Open-Label, Post Market Study: Study the Effects of Differential Target Multiplexed Spinal Cord Stimulation (DTM™SCS) Programs in Treating Intractable Chronic Back Pain in Subjects Without Prior History of Spine Surgery
Phase: NA
Conditions: Chronic Back Pain
Sponsor: SGX Nova LLC

 
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CLINICAL INVESTIGATIONAL PLAN 
Open-Label, Post Market Study: A Clinical Trial to Study the Effects of DTM Spinal Cord 
Stimulation (DTM™SCS) programs in treating Intractable Chronic Back Pain in Subjects 
 without prior history of Spine Surgery 
Protocol Number: 
 
 
DTM-NOVA-2020PM1 
 
NCT Number:  
 
 
NCT04571242 
 
Study Reference: 
 
 
DTM-SCS RCT DDD 
 
Sponsor: 
 
 
 
SGX Nova 
2406 E. Empire St. 
Bloomington, IL 61704 
 
Study Responsibility:  
 
Wesley Park 
 
 
 
 
 
Vice President, Clinical Affairs 
 
 
 
 
 
SGX Nova 
 
Date of Issue:  
 
 
 April 21, 2020 
 
Revision: 
 
 
 
3.0 
 
Revision History: 
 
 
 
 
 
 
Revision 
Description 
Date 
1.0 
Initial Release of Investigational Plan 
21 Feb 2020 
2.0 
Remote Visits 
19 Mar 2020 
3.0 
Remote Programming 
21 Apr 2020 

 
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Study Synopsis 
Study Title 
Open-Label, Post Market Study: A Clinical Trial to Study the Effects of 
Differential Target Multiplexed Spinal Cord Stimulation (DTM™SCS) programs 
in treating Intractable Chronic Back Pain in Subjects without prior history of 
spine surgery 
 
Protocol 
Number 
DTM-NOVA-2020PM1 
Study 
Device 
The IntellisTM neurostimulator, a Spinal Cord Stimulation (SCS) device system 
manufactured and commercialized by Medtronic (Minneapolis, MN) 
 
Study 
Purpose 
The purpose of this investigational study is to study the effects of Differential 
Target Multiplexed Spinal Cord Stimulation (DTM-SCS) in subjects with 
chronic, intractable pain of the trunk with or without lower limb pain, including 
unilateral or bilateral pain without prior history of spine surgery and refractory to 
conservative and surgical interventions 
 
Study 
Design 
This is an open-label prospective, randomized, controlled, multi-center study 
comparing DTM-SCS programming approach to Conventional SCS 
programming approach. 
 
Subjects meeting study entrance criteria will be randomized in a 1:1 ratio to one 
of two study treatment groups: 
• Test treatment group with DTM-SCS programming approach  
• Control treatment group with Conventional SCS programming approach 
 
Data at follow-up visits will be compared between the two treatment groups, and 
in reference to baseline assessments collected at the beginning of the study.  
 
There is an optional two-way crossover to the other treatment group available for 
all subjects who remain implanted at  6 month visit.  
 
Study Size 
Up to 250 subjects may be enrolled at up to 20 clinical sites in the United States 
in order to include an estimated 135 subjects to the point of randomization.   
 
This would allow a minimum of 100 subjects (50% in each treatment arm) to 
complete the 3-month endpoint. 
 
Study 
Duration 
The expected total duration of this study is approximately 32 months.   
Enrollment of subjects is expected to last 18 months.  
Subjects who have received the permanent implant will be followed up for 
approximately 14 months. This consists of Baseline assessments, up to 10 days of 
trial stimulation, and 12 months of treatment following implantation and 
activation of the device.  

 
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Study 
Objective 
The primary objective of this study is to evaluate the effectiveness of DTM-SCS 
in reducing back pain as compared to Conventional SCS for the treatment of 
intractable chronic back pain. 
Inclusion 
Criteria 
A subject must MEET ALL of the following inclusion criteria: 
1. Be a candidate for SCS system (trial and implant) per labeled indication (back 
pain with or without leg pain) 
2. Have been diagnosed with chronic, refractory axial low back pain with a 
neuropathic component and are not eligible for spine surgery (e.g., lumbar 
fusion, discectomy, laminectomy, laminotomy) at the time of enrollment 
3. Has an average back pain intensity ≥ 6.0 cm on the 10.0 cm Visual Analog 
Scale (VAS) at the time of enrollment  
4. Be willing and capable of giving written informed consent to participate in 
this clinical study based on voluntary agreement after a thorough explanation 
of the subject’s participation has been provided. 
5. Be willing and capable of subjective evaluation, read and understand written 
questionnaires, and read, understand and sign the written inform consent. 
6. Be 18 years of age or older at the time of enrollment 
7. Be on a stable pain medication regimen, as determined by the study 
investigator, for at least 30 days prior to enrolling in this study 
8. Be willing to not increase pain medications from baseline through the 3-
Month Visit 
9. Be willing and able to comply with study-related requirements, procedures, 
and visits 
 
Exclusion 
Criteria 
A subject must NOT MEET ANY of the following exclusion criteria: 
1. Had previous lumbar spinal surgery (e.g., lumbar fusion, discectomy, 
laminectomy, laminotomy)  
2. Has a medical, anatomical, and/or psychosocial condition that is 
contraindicated for commercially available IntellisTM SCS systems as 
determined by the Investigator 
3. Has a diagnosed back condition with inflammatory causes of back pain (e.g., 
onset of severe pain with activity), serious spinal pathology and or 
neurological disorders, as determined by the Investigator 
4. Be concurrently participating in another clinical study 
5. Has an existing active implanted device such as a pacemaker, another SCS 
unit, peripheral nerve stimulator, and/or drug delivery pump, etc. 
6. Has a pain in other area(s) and/or medical condition requiring the regular use 
of significant pain medications that could interfere with accurate pain 
reporting, and/or confound evaluation of study endpoints, as determined by 
the Investigator 
7. Has mechanical spine instability as determined by the Investigator 
8. Has undergone, within 30 days prior to enrollment, an interventional 
procedure and/or surgery to treat back and/or leg pain, which is providing 
significant pain relief  
9. Has unresolved major issues of secondary gain (e.g., social, financial, legal), 
as determined by the investigator 

 
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10. Be involved in an injury claim under current litigation or has a pending or 
approved worker’s compensation claim 
11. Be pregnant (determined by urine testing unless female subject is surgically 
sterile or post-menopausal. If female, sexually active, and childbearing age, 
subject must be willing to use a reliable form of birth control.) 
Primary 
Endpoint 
The primary efficacy endpoint is the percentage of randomized subjects who 
respond (a decrease in back pain VAS by at least 50% compared to baseline) to 
SCS therapy at 3 months (non-inferiority analysis).  Subjects who do not have a 
successful Trial Phase are considered failures (non-responders) toward the 
primary endpoint. 
 
 
Table of Contents 
 
CLINICAL INVESTIGATIONAL PLAN ................................................................................1 
Study Synopsis ................................................................................................................................2 
A.  Purpose ......................................................................................................................................7 
A.1.  Study Device .....................................................................................................................7 
A.2.  Purpose of the Investigation ..............................................................................................7 
A.3.  Study Size .........................................................................................................................7 
A.4.  Duration of the Investigation ............................................................................................8 
B.  Protocol .....................................................................................................................................8 
B.1.  Rationale for Study............................................................................................................8 
B.2.  Study Objectives .............................................................................................................10 
B.3.  Selection of Study Population .........................................................................................10 
B.3.1.  Study Population ..............................................................................................10 
B.3.2.  Inclusion Criteria ..............................................................................................10 
B.3.3.  Exclusion Criteria .............................................................................................11 
B.4.  Treatment Groups ............................................................................................................12 
B.5.  Study Design ...................................................................................................................12 
B.5.1.  Overall Design..................................................................................................12 
B.5.2.  Bias Minimization ............................................................................................12 
B.5.3.  Comparison Groups..........................................................................................13 
B.5.4.  Blinding ............................................................................................................13 
B.5.5.  Sample Size ......................................................................................................13 
B.5.5.1 Sample size rationale and statistical power .....................................................13 
B.5.5.2 Overall Sample Size and Enrollment ..............................................................14 
B.5.6.  Study Duration .................................................................................................14 
B.5.7.  Interim Administrative Analyses .....................................................................14 
B.6.  Enrollment, Assessments, Randomization, and Clinical Procedure ...............................15 
B.6.1.  Summary of Study Protocol .............................................................................15 

 
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B.6.2.  Consent/Enrollment ..........................................................................................18 
B.6.3.  Entry Criteria Evaluation .................................................................................18 
B.6.4.  Baseline ............................................................................................................18 
B.6.5.  Randomization .................................................................................................18 
B.6.6.  SCS Trial Phase ................................................................................................19 
B.6.7.  End of Trial Assessment ..................................................................................19 
B.6.8.  Permanent Device Implant (0-60 days from end of successful Trial Phase) ...20 
B.6.9.  Device Activation (0-14 days following Permanent Implant) .........................20 
B.6.10.  Unscheduled Visits .........................................................................................20 
B.6.11.  Telephone Calls ..............................................................................................20 
B.6.12.  1 Month After Device Activation (± 15 days) ...............................................21 
B.6.13.  3 Months After Device Activation (± 21 days) ..............................................21 
B.6.14.  6 Months After Device Activation (± 31 days) ..............................................21 
B.6.15.  9 Months After Device Activation (± 31 days) ..............................................21 
B.6.16. 12 Months After Device Activation (± 45 days) .............................................21 
B.6.17  Other Assessments and Information ...............................................................22 
B.6.18.  Device Explant ...............................................................................................23 
B.6.19.  Early Subject Withdrawal ..............................................................................23 
B.6.20.  Study Completion ...........................................................................................23 
B.6.21.  Study Suspension and Termination ................................................................23 
B.7.  Study Endpoints ..............................................................................................................24 
B.7.1.  Definition of Analysis Populations ..................................................................24 
B.7.2.  Effectiveness Assessment Definitions .............................................................25 
B.7.3.  Primary Endpoint .............................................................................................25 
B.7.4.  Secondary Endpoints ........................................................................................25 
B.7.5.  Additional Data Collection...............................................................................26 
B.8.  Evaluation Criteria ..........................................................................................................27 
B.8.1.  Effectiveness ....................................................................................................27 
B.8.2.  Definition of Success .......................................................................................27 
B.8.3.  Safety ................................................................................................................28 
B.8.3.1 Definitions .......................................................................................................28 
B.8.3.2 Reporting .........................................................................................................29 
B.9.  Data Collection and Analysis ..........................................................................................29 
B.9.1.  Data Collection .................................................................................................29 
B.9.2.  Statistical Analysis ...........................................................................................32 
B.9.2.1 Primary Analyses ............................................................................................32 
B.9.2.2 Secondary Analyses ........................................................................................32 
B.9.2.3 Additional Data ...............................................................................................33 
B.9.2.4 Handling of Missing Data ...............................................................................34 
C.  Risk Analysis ..........................................................................................................................34 
C.1.  Description and Analysis of All Increased Risks to Subjects .........................................34 
C2.  Minimization of Risks ......................................................................................................36 
D.  Description of the Device .......................................................................................................37 
D.1.  Each Important Component, Ingredient, and Property of the Device .............................37 
D.1.1.  Device System Overview .................................................................................37 

 
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D.1.2.  Device System Details .....................................................................................37 
D.1.2.1  Major Components .........................................................................................37 
D.1.2.2.  Surgical Accessories .....................................................................................39 
D.2.  Principle of Operation of the Device ..............................................................................40 
D.3.  Labeling ..........................................................................................................................40 
D.4.  Any Anticipated Changes in the Device .........................................................................40 
E.  Administrative Procedures ....................................................................................................40 
E.1.  Monitoring .......................................................................................................................40 
E.1.1.  Study Clinical Monitor .....................................................................................40 
E.1.2. Monitoring Procedures ......................................................................................40 
E.2.  Data Quality Assurance ...................................................................................................41 
E.3. Study Conduct ..................................................................................................................41 
E.4.  Informed Consent Materials ............................................................................................42 
E.5 Investigators and Institutions .............................................................................................42 
E.6. Amendments and Deviations ............................................................................................42 
E.7. Additional Record and Reports ........................................................................................43 
F.  Appendices ..............................................................................................................................44 
G.  References ...............................................................................................................................45 
 
 
 

 
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A.  Purpose 
A.1.  Study Device 
The IntellisTM neurostimulator is a commercially available implantable component of a Spinal 
Cord Stimulation (SCS) device system manufactured by Medtronic (Minneapolis, MN). The 
system is indicated for spinal cord stimulation (SCS) as an aid in the management of chronic, 
intractable pain of the trunk and/or limbs-including unilateral or bilateral pain associated with 
conditions, including Degenerative Disk Disease (DDD)/herniated disk pain refractory to 
surgical and conservative interventions.  It is designed to deliver electrical stimulation to the 
spinal cord using arrays of electrodes (also called leads) placed in the dorsal epidural space.  
The study will use commercially available IntellisTM neurostimulator and compatible SCS 
system components from Medtronic in accordance to the approved FDA indications and 
labeling. Section D of this Investigational Plan provides detailed description of IntellisTM 
neurostimulator. 
 
A.2.  Purpose of the Investigation 
The purpose of this post-market study is to evaluate the effects of Differential Target Multiplex 
SCS (DTM™SCS) programs in subjects with chronic, intractable pain of the trunk with or 
without lower limb pain associated with the following conditions: Degenerative Disk Disease 
(DDD)/herniated disk refractory to conservative and not a candidate for surgical interventions, 
in the abscense of previous back surgery. Differential Target Multiplexed SCS (DTM-SCS) 
programming approach relies on stimulation parameters that will be set to levels that span 
above the perception threshold, yet well below the levels that could cause uncomfortable 
paresthesia.  This study is a post market, open-label, multi-center, prospective, randomized, 
controlled clinical trial that evaluates the treatment outcomes resulting from DTM-SCS 
programming approach and Conventional SCS programming approach. Both programming 
approaches will be discussed in section B.1 of this Investigational Plan. 
 
This investigation is not comparing two different Spinal Cord Stimulation systems and their 
compatible device components.  Both DTM-SCS and Conventional SCS programs will utilize 
an FDA-approved and commercially available SCS system (IntellisTM neurostimulator and 
compatible SCS components) as is, without any modification using approved parameters under 
approved labeling for indicated population. Outcomes will be assessed via standardized tests.  
 
A.3.  Study Size 
Up to 250 subjects may be enrolled at up to 20 clinical sites in the United States in order to 
include an estimated 135 subjects to the point of randomization and trial phase.  This would 
allow a minimum of 100 subjects (50% in each treatment arm) to complete the 3-month 
endpoint. Sample size estimates are discussed further in section B.5.5 of this Investigational 
Plan.  
 
 
 

 
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A.4.  Duration of the Investigation 
The expected total duration of this study is approximately 32 months.  Enrollment of subjects 
is expected to last 18 months. Subjects that have received the permanent implant will be 
followed up for approximately 14 months. This consists of Baseline assessments, up to 10 days 
of trial stimulation, and 12 months of treatment following implantation and activation of the 
device.  
 
B.  Protocol 
B.1.  Rationale for Study 
It is estimated that about 20% percent of the population worldwide is affected by moderate to 
severe chronic pain1. Chronic pain becomes a burden to the individual as this affects a person’s 
ability to carry out many daily life activities, such as exercising, walking, driving a car, 
attending social events, or performing household chores.  In the United States, chronic pain is 
considered one of the most pervasive and intractable conditions affecting at least one third of 
the population at an estimated cost of five hundred billion dollars per year, when combining 
health-related expenditure and the cost-impact on loss of productivity and income2.  
Conventional medical management, including medication and physical therapy, is often not 
adequate for treating chronic pain. Medication therapy based on opioids may also lead to 
addiction. Extensive use of opioid medications in the United States has led to the declaration 
of an epidemic crisis3. When these treatments fail to provide pain relief, imaging is performed 
to assess candidacy for back surgery4. However, surgery is only indicated for those patients 
with mechanical instability or pinched nerves5.  For the many patients for whom imaging does 
not clearly show a cause of chronic back pain, or for the patients that have confounding medical 
issues precluding an invasive surgical procedure, there are few alternative treatment options6. 
Furthermore, surgical interventions have also failed to remediate severe cases of neuropathies 
and intractable back pain for many patients. Yoshihara et al. evaluated the surgical trends for 
lumbar degenerative disc disease in the US from 2000 to 20097. They reported a 2.4-fold 
population-adjusted increase. Bae et al. reported an increase in the number of lumbar surgical 
fusion for spinal stenosis from 21.5% to 31.2% between 2004 and 20098. Reoperation rate for 
disc herniation and spinal stenosis varied between 10 to 23%9. Overall, 40% of patients 
developed post-laminectomy syndrome or failed back surgery syndrome, requiring further 
treatment, with an estimated incidence of 80,000 cases per year10. Spinal cord stimulation 
(SCS) is a proven therapy that has been in use for about 50 years for various types of chronic 
pain. SCS is a reversible therapy that allows patients to evaluate the therapy for several days 
using an external neurostimulator (ENS) prior to receiving an implantable neurostimulator 
(INS) system11,12,13,14. Taylor et al, showed the cost effectiveness of SCS versus surgery and 
other interventions at $7,058 USD per quality adjusted life year15.  
Spinal Cord Stimulation (SCS) utilizes pulsed electric fields that are applied to the dorsal 
section of the spinal cord via electrode arrays, called leads, implanted in the epidural space.   
Conventional SCS programming approach utilizes pulsed electric fields oscillating in the 40-
250 Hz frequency range. The electric field creates a stimulation pattern (paresthesia) that 
overlays with the targeted pain location. The concept behind Conventional SCS is that the 
stimulation pattern masks pain signals travelling to the brain. Conventional SCS programming 

 
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typically involves giving patients a few program groups, allowing patients to select the 
program group that suits them best. Each program group contains multiple programs that 
deliver, for a given pulse rate, different stimulation parameters (e.g. pulse width, amplitude) to 
same or different electrodes. This approach has been used to create better stimulation patterns 
for the given patient’s pain locations or more tolerable stimulation depending on patient’s 
different positions or postures.  
Historically, Conventional SCS has not had high success for back pain patients due to the 
challenge of having the stimulation pattern overlap the back-pain region without causing 
uncomfortable paresthesia. Although different approaches to SCS exist, Conventional SCS still 
remains the most used SCS programming approach in treating chronic back and leg pain.  
DTM-SCS programming approach relies on stimulation parameters that will be set to levels 
that span above the perception threshold, yet well below the levels that could cause 
uncomfortable paresthesia, which may result in greater pain relief.  This can be done with 
programming parameters that are currently available on the device. 
In a given program group, DTM-SCS will provide programs with different pulse rates and 
pulse widths for the goal of better pain relief.  For example, starting parameters may be a 
combination of a program with 50 Hz pulses with duration of up to 200 microseconds setting 
and a program with 300 Hz with a pulse duration of up to 200 microseconds.  This 
programming approach could result in patients experiencing less uncomfortable stimulation 
than with the Conventional SCS programming approach. This is possible because an DTM-
SCS program group contains programs that allow subjects to access amplitudes below ones 
that could cause uncomfortable paresthesia and make more adjustments to the amplitude..   
There is an ongoing post-market, open-label, prospective, randomized controlled study 
(NCT03606187) evaluating the DTM-SCS programming approach versus the Conventional 
one. The study includes more than 100 subjects randomized in 12 sites in the U.S. At the 3-
month primary endpoint, the responder rate (percentage of subjects with ≥50% pain relief) for 
DTM-SCS programming was 80% vs 51% for the active control arm. Thus, the study met the 
primary objective for non-inferiority. A secondary objective of superiority of DTM-SCS was 
also met for the primary outcome. In addition, the mean percent of back pain relief relative to 
baseline at the 3-months follow up for DTM-SCS was 74% vs. 46% for conventional 
programming.   
Thus, the ongoing study has shown that DTM-SCS is more effective than conventional SCS at 
the 3-month primary endpoint of the study.  Results also show that DTM-SCS shows a risk 
profile in line with that widely documented for conventional SCS.  
Therefore, DTM-SCS offers an alternative approach that might help thousands of chronic pain 
sufferers make substantial improvement in pain relief, reduction in disabilities, and reduce the 
likelihood of uncomfortable paresthesia. 
A multicenter feasibility study (NCT03110601) has also been completed in which DTM-SCS 
programming approach was evaluated during the required period for trialing SCS therapy. In 
this acute study 20 subjects completed a trial with DTM-SCS and Conventional SCS 
programming approaches.  In terms of back pain relief, DTM-SCS programming approach 
provided a mean of 68% pain relief and Conventional SCS programming approach provided a 
mean of 43% pain relief, which translates to DTM-SCS achieving 25% greater reduction than 

 
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Conventional SCS.  Notably with DTM-SCS, 80% of subjects experienced 50% or better back 
pain relief, and 85% of the subjects preferred therapy received through DTM-SCS 
programming approach.  The safety results were in line with expectations of previous SCS 
studies and were mostly resolved within a few days with minimal interventions.  There was 
one serious adverse event, epidural abscess, which although uncommon, is well established as 
a potential risk in SCS trial and was not related to either programming approach. There were 
no unanticipated adverse events. 
The study is a post market, open-label, prospective, randomized, controlled multi-center study 
that will evaluate DTM-SCS programming and Conventional SCS programming for chronic 
back with or without leg pain sufferers without previous back surgery.  There is an optional 
two-way crossover to the other treatment group available for all subjects who remain implanted 
at  the 6 month visit. This scientifically sound study will provide more information on the 
effectiveness of DTM-SCS programming approach. 
 
B.2.  Study Objectives 
The primary objective of this study is to evaluate the effectiveness of DTM-SCS in reducing 
back pain as compared to Conventional SCS for the treatment of intractable chronic back pain 
in subjects without prior history of spine surgery. 
The secondary objectives of this study are to further demonstrate the effectiveness of the DTM-
SCS when compared to Conventional SCS for the treatment of chronic pain of the trunk and 
limbs.  This study will also include the characterization of the safety of DTM-SCS. 
 
B.3.  Selection of Study Population 
 
B.3.1.  Study Population  
The intended study population is individuals suffering from chronic, intractable pain of the 
trunk and/or limbs who are not considered candidates for spine surgery and are candidates 
for commercially available SCS device systems.  
 
B.3.2.  Inclusion Criteria 
In order to participate in the study, a subject must MEET ALL of the following inclusion 
criteria: 
1. Be a candidate for SCS system (trial and implant) per labeled indication (back with 
or without leg pain) 
2. Have been diagnosed with chronic, refractory axial low back pain with a 
neuropathic component and are not eligible for spine surgery (e.g., lumbar fusion, 
discectomy, laminectomy, laminotomy) at the time of enrollment  
3. Has an average back pain intensity ≥ 6.0 cm on the 10.0 cm Visual Analog Scale 
(VAS) at the time of enrollment 

 
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4. Be willing and capable of giving written informed consent to participate in this 
clinical study based on voluntary agreement after a thorough explanation of the 
subject’s participation has been provided. 
5. Be willing and capable of subjective evaluation, read and understand written 
questionnaires, and read, understand and sign the written inform consent  
6. Be 18 years of age or older at the time of enrollment 
7. Be on a stable pain medication regime, as determined by the study investigator, for 
at least 30 days prior to enrolling in this study 
8. Be willing to not increase pain medications from baseline through the 3-Month 
Visit 
9. Be willing and able to comply with study-related requirements, procedures, and 
visits 
 
B.3.3.  Exclusion Criteria 
In order to participate in the study, a subject must NOT MEET ANY of the following 
exclusion criteria: 
1. Had a previous spinal surgery (e.g., lumbar fusion, discectomy, laminectomy, 
laminotomy) 
2. Has a medical, anatomical, and/or psychosocial condition that is contraindicated 
for commercially available IntellisTM SCS systems as determined by the 
Investigator 
3. Has a diagnosed back condition with inflammatory causes of back pain (e.g., 
onset of severe pain with activity), serious spinal pathology and or neurological 
disorders as determined by the Investigator 
4. Be concurrently participating in another clinical study 
5. Has an existing active implanted device such as a pacemaker, another SCS unit, 
peripheral nerve stimulator, and/or drug delivery pump, etc. 
6. Has pain in other area(s) and/or medical condition requiring the regular use of 
significant pain medications that could interfere with accurate pain reporting, study 
procedures, and/or confound evaluation of study endpoints, as determined by the 
Investigator 
7. Has mechanical spine instability as determined by the Investigator 
8. Has undergone, within 30 days prior to enrollment, an interventional procedure 
and/or surgery to treat back and/or leg pain, which is providing significant pain 
relief  
9. Has unresolved major issues of secondary gain (e.g., social, financial, legal), as 
determined by the investigator 
10. Be involved in an injury claim under current litigation or has a pending or 
approved worker’s compensation claim 
11. Be pregnant (determined by urine testing unless female subject is surgically sterile 
or post-menopausal. If female, sexually active, and childbearing age, subject must 
be willing to use a reliable form of birth control.) 
 

 
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B.4.  Treatment Groups 
Subjects meeting the study entrance criteria will be randomized to one of two study treatment 
groups in a 1:1 ratio: 
• Control Treatment Group: Conventional SCS programming approach  
o Stimulation parameters in the 40-250 Hz frequency range will be trialed 
according to standard practice as described in the IntellisTM labeling/manuals 
▪ If frequency parameter above 250 Hz is used during the study, the 
subject will be counted as failure towards Coventional SCS 
programming approach but will continue to permanent implant.  
• Test Treatment Group: DTM-SCS programming approach 
o As with Conventional SCS programming, stimulation parameters will be trialed 
according to standard practice as described in the IntellisTM labeling/manuals. 
Subjects will be given multiple program groups to try. Each DTM-SCS program 
group will have multiple parameters.  The stimulation parameters will be within 
the specifications described in the IntellisTM labeling/manuals.  Each DTM-SCS 
program group has at least two programs with different pulse rate in the 50 to 
1,000 Hz range and each having a maximum pulse width of 1 ms. The subject 
will progress through each of the program groups until satisfactory pain relief 
has been reached. The subject will be able to adjust the amplitude of the signals 
as deemed needed to obtain pain relief.  If sufficient pain relief is not achieved 
with the initial program group, the subject will be instructed to trial another 
DTM-SCS program group. 
 
B.5.  Study Design 
 
B.5.1.  Overall Design 
This is a post market, open-label, multi-center, prospective, randomized, controlled study 
to evaluate DTM-SCS in subjects with chronic, intractable pain of the lower back.  Data at 
follow-up visits will be compared between the two treatment groups, and in reference to 
baseline assessments collected at the beginning of the study. 
 
B.5.2.  Bias Minimization 
This Investigational Plan and its associated documentation have been designed to minimize 
potential sources of bias.  Each Investigator’s qualification for meeting the requirements 
of this investigational plan will be reviewed prior to their participation in this investigation.  
Randomization of subjects to one of the two treatment groups will occur after the subject 
completes Baseline assessments in order to minimize selection bias.  
Each therapy, DTM-SCS programs and Conventional SCS programs, will be programmed 
by clinical representatives of SGX and Medtronic respectively, and in accordance with 
their Conventional therapy algorithms for optimal pain relief. This will minimize bias 
related to potential preference by a given clinical representative to a particular SCS therapy.  

 
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B.5.3.  Comparison Groups 
Both groups in the study are active treatment groups. Treatment outcomes from subjects in 
the DTM-SCS group will be compared to those of the Conventional SCS group.   
 
B.5.4.  Blinding 
Due to the nature of the programs, it is not feasible to blind the subjects, implanting 
physicians or the clinical site personnel to the DTM-SCS programming and Conventional 
programming SCS group assignments. Each SCS group will be programmed under the 
direction of physicians with support of clinical representatives of the Test and Control 
treatments, which may identify the type of treatment to study participants. Also, open 
communication about sensation of paresthesia and pain relief is important in adjusting 
program parameters to provide optimal pain relief for subjects. The assessments of device 
performance are done by the subjects and not by the site personnel so the lack of blinding 
of site personnel should not affect results as pain is the major assessment and subjects tend 
to describe pain truthfully since it affects their everyday life dramatically and not be 
influenced by knowledge of the device programming. Despite the inability to blind the 
study, past SCS studies indicate that there is no reason to believe that subjects and 
Investigators/clinical staff will be influenced one way or another by the knowledge that a 
particular SCS program has been used. Best efforts will be made to limit bias by training 
investigators, clinical site personnel, and all clinical representatives on the relevant areas 
of the study protocol to limit their influence. 
 
B.5.5.  Sample Size 
Primary Endpoint Assessment occurs at the follow up visit 3 months after Device 
Activation.  Based on the primary endpoint requirement, the estimated sample size of this 
study is 100 total subjects (approximately 50 subjects in the DTM-SCS group and 
approximately 50 subjects in Conventional SCS group) who have passed screening 
requirements, have been randomized, and have completed the primary endpoint 
assessment.  Randomization of approximately 135 subjects is planned to maintain power 
in the event of attrition.  
 
The clinical investigational plan requires a screening process for all subjects that provide 
written informed consent. These subjects will undergo screening to assess eligibility. 
Subjects may be excluded for various reasons during screening.  Accordingly, in order to 
include an estimated 135 subjects to the point of randomization and trial phase, up to 250 
subjects may need to be consented and enrolled to account for exclusions prior to 
randomization.  
 
B.5.5.1 Sample size rationale and statistical power 
The sample size estimate to determine primary endpoint is based on the primary 
objective of demonstrating non-inferiority of the test group to the control group at 3 

 
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months.  Established methods were followed in determining the non-inferiority criteria 
and the related sample size estimate 
• Test basis:  Farrington-Manning binomial test for non-inferiority 
• Estimated responder rate of 70% in the test group and 50% in the control 
group 
• Significance level, alpha, of 0.05 one-sided 
• Statistical power = approximately 90% or greater 
• Non-inferiority margin of 10% 
• Randomization:  1:1 
Based on these assumptions, a minimum of 50 randomized and trialed subjects per 
treatment group (100 total) are required. 
 
B.5.5.2 Overall Sample Size and Enrollment 
Based on the primary endpoint requirement, a minimum of 50 subjects per treatment 
group are required (100 total). To account for a combined estimated attrition of 25% 
for subjects that do not complete the Trial Phase, and subjects that exit study before 
the 3-month primary endpoint visit, approximately 135 subjects would need to be 
randomized and trialed.    
To account for 46% attrition prior to randomization (including subject ineligibility 
after signing the informed consent and subject dropout), it is estimated that a total of 
up to 250 subjects would need to be enrolled in the study. 
 
B.5.6.  Study Duration 
This study is expected to last approximately 32 months.  Enrollment of subjects is expected 
to last 18 months. Subjects who are expected to complete the study will commit to it for 
approximately 14 months. This consists of Baseline assessments, up to 10 days of trial 
stimulation, and 12 months of treatment following implantation and activation of the 
device.  
 
B.5.7.  Interim Administrative Analyses  
 
For the purposes of business decisions and planning purposes (e.g., to provide an update to  
third-party investors), administrative analyses may be performed.  The results of the 
analyses will not be widely distributed, and access will be limited to those persons with a 
“need to know”.  Access will be restricted from those involved directly with the study 
conduct or management to prevent the introduction of bias.  The administrative analysis 
will not be used to modify the trial or stop early for potential benefit. As there is no chance 
of early stopping, the type I error rate is not affected. Limiting changes to the protocol and 
access to the interim administrative analysis also prevents operational bias due to 
knowledge of interim results. 

 
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B.6.  Enrollment, Assessments, Randomization, and Clinical Procedure 
Enrollment of subjects will occur at the clinical sites after Institutional Review Board (IRB) 
approvals, and when written informed consent from subjects has been obtained.  Prior to 
enrollment, Investigators and clinical site staff will approach subjects, who have been 
determined to be candidates for SCS therapy and talk about potential participation in the study.  
Following informed consent, the eligibility of subjects to participate in the study will be 
assessed according to inclusion and exclusion criteria outlined in this Investigational Plan.  
Various assessments including pain intensity, evaluation of medical history and records, and 
the Investigator’s clinical judgment will be used in the selection process.  
 
B.6.1.  Summary of Study Protocol 
Potential study subjects will be identified from a pool of candidates for SCS therapy that 
are either affiliated with or referred to the clinical sites.  Notice of availability of the study 
may be used for recruitment purposes, upon approval of the patient recruitment materials 
by the study IRB(s). An informed consent form (ICF) will be given to the potential subject 
for private evaluation. The Investigator or Study Clinical Staff will be available to respond 
to any questions the potential subject may have during evaluation of the ICF. Potential 
study subjects willing to participate in the study will visit the study site for providing 
written consent and for evaluation of eligibility based on inclusion and exclusion criteria.  
Subjects may also be consented via a combination of mail and telephone calls. The RC will 
document the telephone calls and follow-up by signing the consent once the subject returns 
the signed consent. The RC will then provide a photo copy to the subject. Once a consented 
subject is deemed qualified to participate in the study, baseline assessments and 
randomization will occur followed by scheduling of the trial stimulation phase with the 
assigned treatment group.  Subjects who complete a successful SCS trial phase will be 
scheduled to receive a permanent implant of leads and the implanted neurostimulator (INS) 
and will undergo 12 months of stimulation delivery with assessments at 1, 3, 6, 9, and 12 
months after the activation of the therapy. 
All subjects who remain implanted at or after the 6 month visit, but are not getting sufficient 
pain relief and would like to try the other treatment arm’s parameters will have the option 
to cross over to the other treatment group (this is an optional two-way crossover).  X-ray 
may be required to determine lead locations. Crossover must be completed within 30 days 
of the 6 month visit.  
Baseline assessments will include measures for pain intensity, use of medication, extent of 
disability, and quality of life. 
Following completion of the baseline assessment, study subjects will be randomized in a 
1:1 ratio to either the DTM-SCS programming group or the Conventional SCS 
programming group.  
After randomization, subjects will undergo a Trial Phase lasting up to 10 days to determine 
subject’s response to assigned treatment group. Temporary or permanent leads and an 
external neurostimulator (ENS) will be used during the Trial Phase. Subjects will evaluate 
the assigned treatment group based on pain intensity under optimal parameters. Those who 
have a "successful Trial Phase" (defined as a 40% or greater pain reduction from Baseline 

 
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in their back pain) will proceed to permanent implantation of a SCS system to evaluate the 
assigned treatment group. 
The implanted neurostimulator (INS) will be activated within 14 days after surgical 
procedure and SCS therapy will be delivered for the next 12 months. Activation of the 
device marks the initial time point for effectiveness evaluation of the study therapies after 
implantation. Assessments of pain intensity, use of medication and adverse events will be 
made at 1 month following Device Activation.  At 3, 6, 9, and 12 months after Device 
Activation, subjects will be assessed for pain intensity, adverse events, extent of disability, 
use of medication, and quality of life (EuroQol EQ-5D-5L). Patient Global Impression of 
Change, and subject satisfaction will also be recorded at 3, 6, 9 and 12 months after Device 
Activation. Subjects have the option to crossover to the other arm after completing the 6 
months visit (up to 30 days after completing the 6 month visit). 
Figure 1 summarizes the sequence of study-related assessments, procedures, and activities. 
 
 

 
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Figure 1.  Study Flowchart 
 
 

 
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B.6.2.  Consent/Enrollment 
Medical records of all subjects deemed by the Investigator to be potential candidates for 
the study will be de-identified and sent to a sponsor designated physician for pre-screening. 
De-identified medical records should include detailed medical and surgical history of the 
pain condition under study as well any information about comorbidities. Any imaging 
studies (such as MRI, CT, X-ray) should be included for evaluation of the study candidate.  
Once the site has received confirmation that subject may be an appropriate candidate for 
this study, the site may proceed with the eligibility process. This de-identified pre-
screening process assists in reducing unnecessary visits for subjects that would not be 
eligible for this study.   
Written informed consent for participation in the study must be obtained from subjects 
before initiation of any study-related activities.  Following informed consent, subjects will 
be assigned a unique subject identification number and will be considered to be enrolled in 
the study.  Eligibility for advancing to the next stage of the study will be evaluated by the 
Investigator based on the defined inclusion and exclusion criteria. Subjects will be assessed 
for pain intensity and disability.  
 
B.6.3.  Entry Criteria Evaluation  
The eligibility of subjects who have consented participation will be assessed based on the 
inclusion and exclusion criteria.  Study subjects must meet all of the study inclusion criteria 
and none of the study exclusion criteria to be eligible.  Assessments for eligibility include 
average pain intensity (which will be used as Baseline pain intensity), medication usage, 
medical records and history, and the Investigator’s clinical judgment.  Subjects with 
confirmed eligibility will proceed to Baseline assessment, while subjects who do not will 
be discontinued from the study.   
 
B.6.4.  Baseline 
Before a subject is randomized, a subject will be requested to fill out standard 
questionnaires that will assess extent of disability, use of medications, and quality of life.  
The medical and surgical history of the subject will be collected. At this visit and 
subsequent visits, the subject will be assessed for adverse events, medication usage and be 
reminded to not increase pain medications from baseline through the 3-Month Visit.  
Pre-operative assessments will follow the standard of care for SCS therapy and be 
determined by the site Investigator.  
 
B.6.5.  Randomization 
Subsequent to completing Baseline assessments, qualifying subjects will be randomly 
assigned to either one of the two study treatment groups: DTM-SCS programming or 
Conventional SCS programming (active comparator).  Randomization will be stratified by 
gender and whether the subject has leg pain or no leg pain at Baseline. Randomization will 
be done at each study site by randomly permuted blocks. 
 

 
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B.6.6.  SCS Trial Phase 
Subjects will undergo a Trial Phase with the randomly assigned treatment group.  The Trial 
Phase will last up to 10 days and in accordance to approved labeling.  Percutaneous leads 
will be placed in the epidural space at a vertebral level based on the subject’s pain condition 
and pain pattern as described in the Physician Implant Manual. Stimulation will be 
delivered from an external neurostimulator (ENS).   
Anterior-posterior (AP) and lateral X-ray imaging will be done following lead implantation 
at the beginning of the Trial Phase. The subject should flex forward prior to the final AP 
and lateral X-ray imaging.  Imaging may also be done when  lead migration is suspected. 
Stimulation therapy will be as follows for each study arm: 
• For Conventional SCS: stimulation parameters in the 40-250 Hz frequency range 
will be trialed according to standard practice as described in the IntellisTM 
labeling/manuals  
• For DTM-SCS: As with Conventional SCS programming stimulation parameters 
will be trialed according to standard practice as described in the IntellisTM 
labeling/manuals. Subjects will be given multiple program groups to try. Each 
DTM-SCS program group will have multiple parameters.  The stimulation 
parameters will be within the specifications described in the IntellisTM 
labeling/manuals.  Each DTM-SCS program group has at least two programs with 
different pulse rate in the 50 to 1,000 Hz range and each having a maximum pulse 
width of 1 ms. The subject will progress through each of the program groups until 
satisfactory pain relief has been reached. The subject will be able to adjust the 
amplitude of the signals as deemed needed to obtain pain relief.  If sufficient pain 
relief is not achieved with the initial program group, the subject will be instructed 
to trial another DTM-SCS program group. 
Adjustments to a program group may be made based on patient feedback following the 
trialing of a particular program group or set of stimulation parameters. The primary factor 
for assessing response to a given program group or stimulation parameters is the subject’s 
self-reported pain relief.  Adjustments to therapy will be attempted until at least 50% self-
reported back pain reduction from baseline is achieved or until conclusion of the trial phase 
(no more than 10 days). Subjects will be assessed for adverse events and medication usage.  
 
B.6.7.  End of Trial Assessment  
At the end of the Trial Phase, subjects will be assessed for pain intensity under optimal 
therapy parameters. Anterior-posterior (AP) and lateral X-ray imaging may  be done at the 
end of the Trial Phase. The subject will be assessed for adverse events and medication 
usage. 
Those who have a "successful Trial Phase" (defined as a 40% or greater pain reduction 
from Baseline in their back pain) will proceed to permanent implantation of a SCS system 
to evaluate the assigned therapy, and permanent implantation of the IntellisTM SCS system 
will be scheduled. A threshold of 40% for the Trial Phase was predetermined as the 
minimum pain reduction that warrants consideration of a permanent implant and an 

 
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opportunity to achieve a 50% pain reduction as defined in the Individual Subject Success 
criterion (see Section B.7.3).)  
Data from subjects who did not achieve 40% or greater pain reduction in back and do not 
receive permanent implantation will be carried forward toward the primary and secondary 
endpoints. These subjects will exit the study after being followed up for two weeks after 
explant of the leads to assess adverse events. 
 
B.6.8.  Permanent Device Implant (0-60 days from end of successful Trial Phase) 
As described in section B.6.7, subjects who underwent a successful trial of the assigned 
SCS therapy and who agreed to continue into the next stage of the study will proceed to 
permanent implantation stage.  
Permanent percutaneous leads will be placed in the epidural space at a vertebral level based 
on the subject’s pain condition and pain pattern as described in the IntellisTM Physician 
Implant Manual. The INS will be implanted by a trained physician according to standard 
practice and following the Physician Implant Manual for the device.  Anterior-posterior 
(AP) and lateral X-ray imaging will be obtained.  Standard practice of a study site for 
prophylactic pre-surgery antibiotics and post-surgery pain medications will be followed). 
Subjects will be assessed for adverse events and medication usage.  
 
B.6.9.  Device Activation (0-14 days following Permanent Implant) 
Clinical site personnel  will assess if healing of surgical wounds is sufficiently appropriate 
to start charging and programming of the INS. The INS will be initially programmed to the 
group therapy or set of stimulation parameters that provided adequate pain relief during the 
Trial Phase. Adjustments to therapy may be made based on patient response to a program 
group or set of stimulation parameters. The subject will be provided with instructions on 
how to operate the charger and patient remote control at this visit.  Subjects will be assessed 
for adverse events and medication usage.  
 
B.6.10.  Unscheduled Visits 
Unscheduled visits may occur at any time during the study for the assessment of possible 
adverse events, changes in pain medication, and programming adjustments.  Each 
unscheduled visit will be documented and recorded on an eCRF. 
 
B.6.11.  Telephone Calls 
Subjects will be contacted by the study coordinator, via a telephone call, before each study 
visit. The study coordinator will check on the well-being of the subject, remind the subject 
of the upcoming scheduled visit, remind the subject not to change pain medication usage 
at least two weeks prior to the scheduled visit, remind the subject not to start any new 
strenuous activity prior to the visit, and remind the subject to contact the Investigator/study 
staff should he/she have any concerns or questions. The telephone calls should be made 
two to three weeks before the scheduled visit. 

 
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B.6.12.  1 Month After Device Activation (± 15 days) 
Subjects will visit the study site where they will be assessed for pain intensity.  
Programming adjustments may be made, as needed. Anterior-posterior (AP) and lateral X-
ray imaging may be done if significant lead migration is suspected. Subjects will be 
assessed for adverse events and medication usage.  
 
B.6.13.  3 Months After Device Activation (± 21 days) 
Subjects will visit the study site where they will be assessed for pain intensity, extent of 
disability, use of medication, quality of life, Patient Global Impression of Change, and 
subject satisfaction. Paresthesia generated by the stimulator will be assessed. Programming 
adjustments may be made, as needed. Anterior-posterior (AP) and lateral X-ray imaging 
will be done. Subjects will also be assessed for possible adverse events and medication 
usage.  
 
B.6.14.  6 Months After Device Activation (± 31 days) 
Subjects will visit the study site where they will be assessed for pain, extent of disability, 
quality of life, Patient Global Impression of Change, and subject satisfaction.  Paresthesia 
generated by the stimulator will be assessed. Programming adjustments may be made, as 
needed.  Anterior-posterior (AP) and lateral X-ray imaging may be done if significant lead 
migration is suspected. Subjects will also be assessed for possible adverse events and 
medication usage.  
After the 6 month assessment is completed, subjects in both arms will have an option to 
change to the other arm if the subject is not receiving sufficient pain relief and desires to 
try the the other arm’s parameters.  The subject can crossover immediately after completing 
the 6 month assessment or within 30 days after completing the 6 month assessment. At the 
time of crossover, imaging may be required to confirm lead location before programming. 
If the subject has gross lead migration and is not a candidate for a lead revision, the subject 
may have to be withdrawn due to the inability to program effectively. If withdrawn, the 
subject would be continued to be followed by their pain physician as a non-study, 
commercial patient.  
 
B.6.15.  9 Months After Device Activation (± 31 days) 
Subjects will visit the study site where they will be assessed for pain, extent of disability, 
quality of life, Patient Global Impression of Change, and subject satisfaction.  Paresthesia 
generated by the stimulator will be assessed. Programming adjustments may be made, as 
needed.  Subjects will also be assessed for possible adverse events and medication usage.  
 
B.6.16. 12 Months After Device Activation (± 45 days) 
The follow-up visit 12 Months after Device activaction is the final scheduled study visit. 
Subjects will visit the study site where they will be assessed for pain, extent of disability, 
quality of life, Patient Global Impression of Change, and subject satisfaction.  Paresthesia 
generated by the stimulator will be assessed. Programming adjustments may be made, as 

 
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needed.  Subjects will also be assessed for possible adverse events and medication usage.   
If there are no ongoing study related adverse events, the subject will complete the study at 
this visit. In situations where there is an ongoing study related adverse event, subjects will 
be followed until resolution of that adverse event or determination that the subject’s 
condition is stable, at which point the Study Completion Clinical Research Form (eCRF) 
should be completed. 
Beyond the 12 month visit, there will be no additional scheduled follow-up visits in the 
study.  Following the last scheduled study visit, subjects will be followed by the 
Investigator at regular intervals, as dictated by standard of care at each site, in order to 
facilitate pain management, stimulation adjustments, possible revisions and/or 
replacements of neurostimulation components. Any additional non-study related 
monitoring of the subject will be the responsibility of the subject’s personal physician, as 
dictated by reasonable medical care. 
 
  
B.6.17  Other Assessments and Information 
At any time during the study, if lead migration is suspected, the subject may have additional 
AP and lateral X-rays taken to confirm the new lead position in order to aid the Investigator 
in determining a course of action. 
Paresthesia testing may also be performed to assess lead location and therapy coverage of 
pain areas. Programming adjustments may be made based on patient feedback following 
assessment. 
Additional information on Medication Usage: 
• The investigator will instruct all subjects to take the Baseline doses of pain 
medication until the 3-Month Visit.  However, after Device Activation Visit, the 
Investigator may reduce the dose of pain medication if the subject is benefitting 
greatly from SCS and not benefitting from Baseline dose pain medication. 
o Subjects should not fluctuate medication usage nor dosages even if the dose 
is at or below Baseline doses. The research coordinator or investigator 
should  instruct all subjects to maintain stable dosing of medication for at 
least two weeks prior to scheduled follow-up visits. 
• Acetaminophen, NSAIDs or other pain medications (new prescriptions or greater 
than Baseline doses) may only be taken for an acute condition and for a limited 
duration. For each type of pain medication, dosing should not exceed the maximum 
daily dosage recommended by the manufacturer and usage should not continue 
beyond 5 days. Should acute pain medication usage coincide with a follow-up visit, 
the visit will be postponed until two weeks after acute pain medication usage has 
been stopped. 
• Following trial and permanent implants, the clinical site’s standard practice for 
prophylactic pre-surgery antibiotics and post-surgery pain medications will be 
followed. Investigators will instruct subjects not to change usage of any other 
concomitant pain medications. 

 
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B.6.18.  Device Explant 
At any time during the study, a subject may elect to withdraw from the study and have the 
SCS device system explanted.  Additionally, an Investigator may elect to explant a device 
due to an adverse event. 
The Investigator must follow the appropriate guidelines set forth by the Medtronic for 
returning the explanted device and/or lead(s) as well as the accessories (charger, patient 
remote control). 
 
B.6.19.  Early Subject Withdrawal 
Although efforts will be made by Investigators and study staff to encourage subjects to 
remain enrolled in the study, subjects may withdraw early from the study for a number of 
reasons, including but not limited to: 
• Failure of SCS Trial Phase 
• Subject request 
• Investigator request 
• Subject lost to follow-up 
• Subject’s death 
• Adverse events (e.g., intolerable adverse event occurrence that forces subject to 
stop participation in the study) 
If a subject is considering withdrawing from the study due to unsatisfactory effectiveness 
of the assigned treatment, the Investigator will make attempts to improve therapy during a 
study visit. When a subject is withdrawn early from the study, a Study Termination eCRF 
will be completed describing the reason for discontinuation.  Study staff will contact 
subjects to remind them about their scheduled visits and make sufficient efforts to locate a 
subject that is not responding to a contact call. In situations where study withdrawal is due 
to an adverse event, subjects will be followed until resolution of the adverse event or 
determination that the adverse event is not likely to change. 
 
B.6.20.  Study Completion 
All subjects enrolled in the study are expected to complete all scheduled visits through the 
follow up visit 12 months after Device Activation.  A Study Completion eCRF should be 
completed at the end of this visit. If there is an ongoing study related adverse event, subjects 
will be followed until resolution of that adverse event or determination that the adverse 
event is not expected to change. 
 
B.6.21.  Study Suspension and Termination 
Subjects will be considered to have completed all study requirements following the 
completion of the follow up visit 12 Months after Device Activation.  Each clinical site 
will be considered to have completed study requirements at the end of the required 
monitored close out visit.  The study will be considered closed  when all of the requirements 
of this Investigational Plan have been fulfilled, all close out visits have been completed and 
all Sponsor and Investigator reports have been issued and reported to the IRB. 

 
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SGX, the Investigators, or the IRB(s) may suspend or terminate the study early at any time.  
If the study is suspended or terminated prematurely, all subjects that are still enrolled will 
be terminated from the study. A Study Completion eCRF will be completed noting that the 
study has been terminated.  If there is an ongoing adverse event related to the device or 
treatment, the subject will be followed until resolution of the adverse event or 
determination that the adverse event is not likely to change.  
Subsequent follow-up of the subjects after study completion will be the responsibility of 
the subject’s personal physician.   
SGX reserves the right to terminate the study but intends only to exercise this right for 
reasons related to the protection of subjects or valid scientific or business reasons.  SGX 
will notify Investigators and IRBs in writing in the event of study termination.   
SGX reserves the right to stop the enrollment of subjects at any clinical site at any time 
after the clinical site initiation. Possible reasons for suspending or terminating a clinical 
site may include, but are not limited to: 
• Non-compliance by Investigator  
• Failure to obtain proper written informed consent 
• Repeated failure to complete or submit eCRFs in a timely manner 
• Failure to report SAEs to the Sponsor within 48 hours of knowledge of the event 
and to reviewing IRB in accordance with its policies 
• Repeated failure to comply with clearance of queries generated during monitoring 
of the study 
• Inactivity 
 
B.7.  Study Endpoints 
 
B.7.1.  Definition of Analysis Populations  
• Modified Intent to Treat (mITT): All successfully randomized subjects who 
complete the Trial Phase. 
• Intent-to-Treat (ITT): All successfully randomized subjects who met all the 
enrollment criteria. 
• Per-Protocol (PP):  All subjects who received a permanent device implant and 
contributed their data to the 3-month endpoint without any major protocol 
deviations or adverse events (that would render their data unevaluable).  
The primary analysis of the primary and secondary endpoints will be performed on 
the mITT population. Supportive analyses will be performed for the Intent-to-Treat 
and Per-Protocol population.  
For analyses incorporating crossover data (i.e. data gathered in the post 6-month 
periods), analyses will be based on the mITT population with treatment group 
defined by the treatment status at the corresponding time point to capture the impact 
of crossover.  Additional sensitivity analyses censoring data post-crossover will be 
performed to examine the impact of crossover. 

 
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B.7.2.  Effectiveness Assessment Definitions 
• Primary Effectiveness Assessment:  For subjects who have a successful Trial Phase 
and receive a permanent implant, the Primary Efficacy Assessment occurs at the 
follow up visit 3 months after Device Activation.  For subjects who do not have a 
successful Trial Phase (based on subject’s pain score) or subjects who do not want 
a permanent device implant due to insufficient pain relief (based on subject’s 
discontinuation reason), the Primary Efficacy Assessment occurs at the end of the 
Trial Phase.  
 
B.7.3.  Primary Endpoint 
Pain rating on the 10 cm Visual Analog Scale is considered the primary outcome 
measure.  VAS is the most widely used outcome measure in assessing pain due to its 
documented reliability and validity, ease in administration, and minimal training 
requirements for the administrator. 
• Individual Responder:  A decrease in back pain VAS by at least 50% 
at 3 months after Permanent Device Activation as compared with 
Baseline. All subjects must be using the assigned programming 
parameters.  If a subject is switched to a programming parameter that 
is not considered to be DTM-SCS nor Conventional SCS programming 
the subject will be counted as a non-responder for the following follow-
up visit if one of the two following conditions exist: 
o If a subject is switched to a programming parameter that is not 
considered to be DTM-SCS nor Conventional SCS 
programming for a period over two weeks 
o If a subject is switched to a programming parameter that is not 
considered to be DTM-SCS nor Conventional SCS 
programming for any length of time within the 2 weeks prior to 
a follow-up visit.  
Overall Study Success:  The percentage of Individual Responders in the test 
group is shown to be statistically non-inferior to the percentage in the control 
group.  
 
B.7.4.  Secondary Endpoints 
The following secondary endpoints will be evaluated:  
• Comparison of the percentage of Individual Responders between the test and 
control groups in a statistical test of superiority over time (i.e. based on repeated 
measures analysis). In addition, data will be summarized at the individual time 
points at 3 months, 6 months, 9 months, and 12 months.  This will be performed 
based on all observed data with treatement defined as a time dependent covariate, 
and additionally based on censoring data post-crossover. 

 
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• Comparison of change from Baseline in back pain score (VAS) between 
test and control in statistical tests of non-inferiority and superiority.  This 
is calculated as: Change from Baseline in Back Pain VAS = Follow-up 
Visit Pain VAS – Baseline Pain VAS. A negative result reflects a decrease 
in the Pain VAS, while a positive result reflects an increase in Pain VAS. 
All subjects must be using the assigned programming parameters.  If a 
subject is switched to a programming parameter that is not considered to 
be DTM-SCS nor Conventional SCS programming, that subject’s Baseline 
Back Pain VAS will used instead of Follow-up Visit VAS after the 
programming change has occurred for the following follow-up visit if one 
of the two following conditions exist: 
o If a subject is switched to a programming parameter that is not 
considered to be DTM-SCS nor Conventional SCS 
programming for a period over two weeks 
o If a subject is switched to a programming parameter that is not 
considered to be DTM-SCS nor Conventional SCS 
programming for any length of time within the 2 weeks prior to 
a follow-up visit.  
 
Analysis of both secondary endpoints will be based on a repeated measures approach 
that accounts for within subject correlation. Treatment group status for the repeated 
measures models will be based on treatment status at the current time point (i.e. it will 
be based on treatment status incorporating potential crossover, not necessarily the 
original randomized assignment).  
 
B.7.5.  Additional Data Collection  
These following data will be collected: 
• Frequency of treatment emergent adverse events 
• Comparison of opioid medication usage from baseline at 3, 6, 9 and 12 months after 
device activation between the two arms 
• Comparison of mean change from Baseline in Leg Pain VAS, evaluated at 3, 6, 9 
and 12 months after device activation for subjects with baseline leg pain VAS score 
≥ 5 between test and control 
• Comparison of Leg Pain Treatment Success, measured as at least a 50% reduction 
in Leg Pain VAS, evaluated at 3, 6, 9, and 12 months after device activation for 
subjects with baseline leg pain VAS score ≥ 5 between test and control 
• Comparison of patient satisfaction between two arms 
• Patient Global Impression of Change, evaluated at 3, 6, 9 and 12 months after 
device activation 
• Comparison of Patient Global Impression of Change between two arms 

 
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• Comparison of ODI change from baseline at 3, 6, 9 and 12 months after device 
activation between the two arms 
• Comparison of quality of life (QoL) change (from EuroQol EQ-5D-5L) from 
baseline at 3, 6, 9 and 12 months after device activation between the two arms 
• Quality of paresthesia at 3, 6, 9 and 12 months, comparison between test and control  
• Percentage of subjects that crossover 
• Comparison of mean change from last visit prior to crossover to 12 months visit.  
This analysis censors data post-crossover. 
• Activity level based on IntellisTM adaptive data log (when available) 
• Analysis of additional evaluable data items will be based on treatment status at the 
current time point (i.e. it will be based on treatment status incorporating potential 
crossover, not necessarily the original randomized assignment).  
 
B.8.  Evaluation Criteria 
 
B.8.1.  Effectiveness 
Results of the tests and standard questionnaires will be recorded in Case Report Forms at 
Baseline and during follow-up visits.  Changes from Baseline will be calculated and 
compared between the two groups.   
Effectiveness will be measured for each subject using the following tests: 
• Pain 
– Visual Analog Scale (VAS, 10 cm) at Baseline, End of Trial Phase, Months 1, 
3, 6, 9 and 12  
• Disability 
– Oswestry Disability Index Questionnaire 
• Quality of Life 
– EuroQol EQ-5D-5L 
• Impression of Change in Quality of Life 
– Patient Global Impression of Change 
• Satisfaction with Therapy 
– Subject Satisfaction Questionnaire 
 
Study personnel will be appropriately trained for administration of each test.  
 
B.8.2.  Definition of Success 
 
The subject’s self-reported pain intensity score based on the 10 cm Visual Analog Scale 
(VAS) is considered the outcome measure for the efficacy component of the primary 
endpoint. VAS is a widely used outcome measure in assessing pain. It is a reliable and valid 

 
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method, which is easy to administer, and requires minimal training for the test 
administrator. VAS scores will be collected for both back and leg pain.   
Study success will be declared if the non-inferiority test for the primary effectiveness 
endpoint is statistically significant.  
There are no additional pre-specified subject or study-level success criteria for secondary 
and tertiary endpoints.  
 
B.8.3.  Safety 
Safety will be assessed by characterizing adverse events at all study visits with descriptive 
statistics. 
 
B.8.3.1 Definitions 
An adverse event (AE) is any untoward medical occurrence in a subject associated 
with the use of the therapy under the study whether or not related to IntellisTM SCS 
system or the study procedures. An AE is also any event related to any underlying 
medical condition, present at baseline, which increases in severity or frequency by a 
clinically meaningful amount during the study as determined by the Investigator.  
For all adverse events, the Investigator will provide an assessment of the relationship 
to the study.  If the adverse event is study-related, the following parameters will be 
assessed: its seriousness, severity, treatment/intervention provided, and resolution. 
As the efficacy measures in this study are back and leg pain, back and leg pain do not 
need to be reported as an adverse event unless it meets the definition of a serious 
adverse event. Investigators may, however, report any other pain-related adverse 
events during the study.   
Pre-existing conditions will not be reported as an adverse event unless there has been 
a substantial increase in the severity or frequency of the problem, which has not been 
attributed to its natural history. 
A serious adverse event (SAE) is an adverse event that  
• Leads to death 
• Leads to serious deterioration in the health of the subject, that either results in  
o a life-threatening illness or injury (life-threatening is defined as at risk 
of death at the time of the event), or 
o a permanent impairment of a body structure or a body function, or 
o in-patient hospitalization or prolongation of existing hospitalization (in-
patient hospitalization is defined as a hospital admission for a period of 
greater than 24 hours), or  
o medical or surgical intervention to prevent life-threatening illness or 
injury or permanent impairment to a body structure or a body function, 
• Leads to fetal distress, fetal death, or a congenital abnormality or birth defect 
Those known adverse events related to the device, procedure or therapy are listed in 
the section C. (Risk Analysis) of this Investigational Plan. 

 
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B.8.3.2 Reporting 
All AEs and SAEs will be assessed and captured from enrollment through the 
completion of the study on the Adverse Event Source Worksheet.  AEs and SAEs will 
be reported as required by the IRB.  
All Adverse Events (see list in section C.1.) assessed/determined to be study-related  
study will document seriousness, severity, treatment/intervention provided, 
relationship to the device/procedure, and resolution.   
Adverse events that are determined to be not study related by the investigator will not 
be reported in the EDC. 
As would be the common practice when using commercial medical devices, device -
related AEs may be reported by the site (per their institutional policy) to the Customer 
Service or Technical Support of Medtronic as specified in the manufacturer's 
labeling/manuals. 
 
This is a post market, open-label study so Data Monitoring Committee will not be 
used.  
  
B.9.  Data Collection and Analysis 
 
B.9.1.  Data Collection 
Study data will be collected using a secure Electronic Data Capture system meeting the 
requirements of 21 CFR part 11. Each data field completed via the EDC system is expected 
to have a verifiable source document.  The clinical site will enter the data from the source 
documents directly into the EDC system. Subject confidentiality will be maintained, and 
each subject will be identified only by the assigned study subject number.  Subject names 
will not be published. Data collection is summarized in Table 1. 
 
Remote data collection from the subjects is allowed. This should be evaluated on a case by 
case basis, pending Investigator’s approval based on safety and clinical condition. Subjects 
who are not demonstrating study compliance, e.g. not returning phone calls, not charging 
device or turning the device off should not be mailed the questionnaires until they 
demonstrate compliance with the study. The site should continue to contact the subject and 
ensure compliance before mailing the questionnaires. The communications will be 
documented in the source worksheets.  
Visit windows remain in place and should be maintained as much as possible. Subjects 
should be contacted via phone to confirm AEs, medications and concurrent procedures. All 
questionnaires required at a visit should be obtained via phone, email or via mail based on 
site and/or subject preference. 
If by phone: site staff will read each question to the subject an record their answers. The 
site staff should initial and date the bottom of each form and indicate that is was completed 
via phone. 

 
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If by email: the site staff should send the provided questionnaires . Subjects can either print 
and manually complete or complete the forms electronically. 
If manually completed (printed): the subject will be instructed to initial and date 
each page and scan and email or mail the responses back to the sites. 
If the forms are completed electronically: the subject will be instructed to complete 
the questionnaires and return the responses to the site. Ideally, questionnaires will 
be completed and returned to the site within 3 business days. 
If the questionnaires are sent in hard copy by mail: the subjects should be instructed to 
complete the questionnaires and initial and date each page after completion and return to 
site as soon as possible. Ideally, within 3 business days of receipt. 
Source documentation should clearly describe the process utilized for each subject at each 
visit when these alternative methods are utilized.  
Remote data collection/remote visits would apply to any visit that could be conducted 
remotely without the subject being present on-site, including remote programming, if 
available. Procedural visits (trial and IPG) and any unscheduled visits required for adverse 
events obviously should continue to be performed on-site when possible.  

 
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Table 1. Schedule of Study Activities 
 
 
 
 
Activity 
Pre-Trial 
Phase 
 
 
Trial Phase 
Permanent Implant 
(up to 60 days after 
end of trial) 
 
Permanent Implant Phase Follow-up 
Enrollment 
Baseline  
Randomization 
Start Trial 
Phase 
End Trial 
Phase (up to10 
days after start 
of trial) 
Device 
Activation (0-14 
days after 
implant) 
1-month visit 
(±15 days after 
activation) 
3 months visit 
(±21 days after 
activation) 
6 months visit 
(±31 days after 
activation) 
9 months visit 
(±31 days after 
activation) 
12 months visit 
(±45 days after 
activation) 
Informed Consent 
X 
 
 
 
 
 
 
 
 
 
 
 
Pain Intensity Evaluation 
(VAS) 
X 
 
 
 
X 
 
 
X 
X 
X 
X 
X 
Medication Use 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Medical/Surgical History 
X 
X 
 
 
 
 
 
 
 
 
 
 
Eligibility Criteria 
Evaluation 
X 
 
 
 
 
 
 
 
 
 
 
 
Disability Assessment (ODI) 
 
X 
 
 
 
 
 
 
X 
X 
X 
X 
Quality of Life Assessment 
(EQ-5D-5L) 
 
X 
 
 
 
 
 
 
X 
X 
X 
X 
Randomization 
 
 
X 
 
 
 
 
 
 
 
 
 
AP/Lateral x-ray imaging 
 
 
 
X 
[X] 
X 
[X] 
[X] 
X 
[X] 
[X] 
[X]  
Paresthesia Questionnaire 
 
 
 
 
 
 
 
 
X 
X 
X 
X 
Patient Global Impression of 
Change 
 
 
 
 
 
 
 
 
X 
X 
X 
X 
Subject Satisfaction 
 
 
 
 
 
 
 
 
X 
X 
X 
X 
Adverse Event Monitoring 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Device Programming 
 
 
 
X 
 
 
X 
[X] 
[X] 
[X] 
[X] 
[X]  
Device Log 
 
 
 
 
 
 
 
 
[X] 
[X] 
[X] 
[X] 
Cross over 
 
 
 
 
 
 
 
 
 
[X] 
 
 
Study Completion 
 
 
 
 
Xa 
 
 
 
 
 
 
X 
a For subjects that do not have a successful Trial Phase.  
[X] Optional activity. 
 

 
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B.9.2.  Statistical Analysis 
Descriptive statistics will be used to summarize baseline and outcome data collected during 
the study.  Continuous variables will be summarized using means, standard deviations, and 
ranges.  Categorical variables will be summarized in frequency distributions. Repeated 
measures models will account for within subject correlation by use of a compound-
symmetric covariance structure (based on logistic regression/generalized estimating 
equations for binary variables, and linear repeated measures models for continuous 
variables). 
 
B.9.2.1 Primary Analyses 
The primary efficacy endpoint will be evaluated with a Farrington-Manning binomial 
test for non-inferiority with a 10% margin at the one-sided 0.05 alpha level. 
H0: The percentage of subjects (P) who achieve a 50% improvement in their back 
VAS pain score at 3 months in the Test group is inferior to that in the Control 
group. 
PTest  ≤  PControl - 10% 
H1: The percentage of subjects (P) who achieve a 50% improvement in their back 
VAS pain score at 3 months in the Test group is not inferior to that in the 
Control group. 
PTest  >  PControl - 10% 
A 10% margin has been previously used in a similar study.16 Meeting the statistical 
threshold for this test based on a 10% margin should produce clinically acceptable 
results.  
 
B.9.2.2 Secondary Analyses 
The following secondary endpoints will be evaluated: 
• If the primary efficacy endpoint in the test group is found to be non-inferior to 
that in the control group, then a secondary endpoint will evaluate whether the 
proportion of subjects who achieve a 50% improvement in their back pain VAS 
score at 3 months in the test group is superior to that in the control group.  A 
superiority test based on the difference in proportions will be performed based 
on the following null hypothesis, with a one-sided p-value of 0.05 or less 
considered evidence of statistical significance. 
H0: 
The proportion of subjects (P) who achieve a 50% improvement in their 
back pain VAS score at 3 months in the Test group is less than or equal 
to that in the Control group. 
PTest   ≤  PControl  
H1: 
The proportion of subjects (P) who achieve a 50% improvement in their 
back pain VAS score at 3 months in the Test group is greater than that 
in the Control group. 

 
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PTest  >  PControl  
• Change in mean VAS will be evaluated with two-sample t-test of non-
inferiority in means with a 0.65 cm margin at 3 months. 
H0: The change (C) in subject’s VAS pain intensity score relative to baseline at 
the Primary Efficacy Assessment in the Test group is inferior to that of 
subjects in the Control group (active control). 
CTest  ≥  CControl - 0.65 cm 
H1: The change (C) in subject’s VAS pain intensity score relative to baseline at 
the Primary Efficacy Assessment in the Test group is not inferior to that of 
subjects in the Control group (active control). 
CTest  <  CControl - 0.65 cm 
The non-inferiority margin of 0.65 cm was selected based on a previous study of a 
similar therapy against traditional SCS16. In that study, the experimental therapy 
showed a 4.9 point improvement while traditional SCS showed a 3.6 point 
improvement for a difference of 1.3 points. Taking 50% of this treatment effect 
yields the margin of 0.65.   
The following secondary endpoints do not have an associated hypothesis, and no 
significance level will be assigned to statistical tests that may be performed. 
Analysis of these endpoints will be based on a repeated measures approach that 
accounts for within subject correlation. Treatment group status for the repeated 
measures models will be based on treatment status at the current time point (i.e. it 
will be based on treatment status incorporating potential crossover, not necessarily 
the original randomized assignment).  
• 
Comparison of Back Pain Treatment Success (responder rate), measured as 
subjects with at least a 50% reduction in Back Pain VAS, between test and 
control 
• 
Comparison of mean change from Baseline in Back Pain VAS, between test 
and control 
 
B.9.2.3 Additional Data 
• Comparison of Leg Pain Treatment Success (responder rate), measured as 
subjects with at least a 50% reduction in Leg Pain VAS, between test and 
control for subjects with baseline leg pain VAS score ≥ 5 
• Comparison of mean change from Baseline in Leg Pain VAS, between test and 
control for subjects with baseline leg pain VAS score ≥ 5 
• Satisfaction with Therapy:  Subject Satisfaction will be compared between test 
and control 
• Patient Global Impression Change:  The Patient Global Impression of Change 
from Baseline to follow-ups at 3-, 6-, 9- and 12-month visits after device 
activation will be compared between the treatment groups. 

 
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• Oswestry Disability Index (ODI):  The changes in ODI from Baseline to 3-, 6-
, 9- and 12-months will be summarized as continuous variables and compared 
between the treatment groups.  
• Quality of Life:  The changes in the EQ-5D-5L instrument from Baseline to 
follow-ups at 3-, 6-, 9- and 12-months will be summarized as continuous 
variables and compared between the treatment groups. 
• Paresthesia Questionnaire: Questions about the paresthesia will be used at 3-, 
6-, 9-and 12-month visits and compared between test and control   
 
B.9.2.4 Handling of Missing Data 
 
Missing data will be minimized by rigorous follow-up and investigator and site 
training. Additionally, for subjects who do not have a successful Trial Phase, 
results from the Trial Phase will be utilized for the primary endpoint as described 
in Section B.7.2.  Effectiveness Assessment Definitions. Any other data will be 
imputed via Multiple Imputation. Additionally, sensitivity analyses for missing 
data will be performed. Unless otherwise specified, all other analyses will be 
based on the evaluable data with no imputation.  
 
Details on imputation will be provided in a separate statistical analysis plan.  
C.  Risk Analysis 
C.1.  Description and Analysis of All Increased Risks to Subjects 
Spinal Cord Stimulation (SCS) Risks: 
DTM-SCS programming approach will be used with commercially available, FDA approved 
IntellisTM SCS system within approved indications for use. Anticipated potential adverse events 
resulting from the study are expected to be in line with adverse events already documented for 
SCS using a Standard programming approach.  
There are known risks associated with the use of any SCS system.  Known risks are associated 
with the implant procedure, the stimulation, the implanted device (not associated with 
stimulation) and external devices such as the charger and remote control. These are typical of 
commercial SCS systems. Subjects will be informed of these anticipated risks in the study 
consent process. 
 
Risks of Surgery 
Implanting a neurostimulation system has risks similar to spinal procedures, including spinal 
fluid leak (spinal fluid collection under the skin), headaches, swelling, bruising, bleeding, 
infection, or paralysis.  
Subjects on anticoagulation therapy may be at higher risk for problems after surgery such as 
hematomas that could result in paralysis. 
 
 

 
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Spinal Cord Stimulation Risks 
The implantation of a spinal cord stimulation system involves risks that are similar to other 
spinal procedures. In addition to those normally associated with surgery, implantation or use of 
a neurostimulation system includes, but is not limited to the following risks: 
• Allergic or immune system response to the implanted materials 
• Infection 
• Lead or neurostimulator erosion through the skin or migration 
• Leakage of cerebrospinal fluid 
• Loss of pain relief may return patients to their underlying pain condition 
• Persistent pain at the neurostimulator site 
• Placement of the epidural lead is a surgical procedure that may expose patients to 
risks of epidural hemorrhage (bleeding), hematoma, or paralysis 
• Radicular chest wall stimulation 
• Seroma (fluid collection in pocket where stimulator is placed) or hematoma at the 
neurostimulator site 
• Change in stimulation, possibly related to cellular changes around the electrode(s), 
shifts in electrode position, loose electrical connections, lead fractures, which has 
been described by some patients as uncomfortable stimulation (jolting or shocking 
sensation) 
• Over time there could be changes in the level of symptom control. In most cases, 
the physician can correct these changes without surgery. 
• Formation of excessive tissue around the lead in the epidural space can result in 
delayed spinal cord compression and paralysis, requiring surgical intervention. 
Time to onset can range from weeks to many years after implant. 
• The safety of this therapy is unknown for pregnancy, unborn fetus, or delivery 
• Stimulation-dependent gastrointestinal symptoms such as diarrhea, incontinence or 
constipation 
• Stimulation-dependent bladder symptoms such as urinary retention, incontinence 
or frequency 
• Unexpected changes in stimulation - Electromagnetic interference, changes in 
posture, and other activities can cause a perceived increase in stimulation 
 
System Revision Risk 
The Intellis AdaptiveStim Neurostimulator may require replacement in 9 years or earlier, 
regardless of the number of times the neurostimulator is recharged.  It is possible that the system 
will need to be revised (explanted, replaced, or repositioned) earlier than 9 years.  Possible 
reasons for revision/explant may include infection, malfunction, and migration of the system 
components.  The risks associated with system revision are equivalent to the commercially 
available systems.    
Pregnancy Risks 
Pregnant women are not able to take part in this study.  Female subjects must agree to not 
become pregnant during the study by using a medically acceptable method of birth control. If a 

 
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subject becomes pregnant during this study, there may be risks to the unborn child that are not 
yet known.  Subjects will be advised and encouraged to notify the study doctor immediately if 
they think they are or have become pregnant.  Subjects that become pregnant during the study 
will be instructed to turn the neurostimulator “OFF” and will be exited from the study. 
Radiographic Imaging 
As part of the study, subjects may  be required to have fluoroscopic or X-ray images taken of 
their thoracic spine  in addition to the imaging conducted to implant the leads.  This may be 
beyond what is standard of care.  The risk associated with these additional images has been 
considered and determined to be minimal since the total radiation dose will be approximately 
the same as one CT scan of the abdomen.     
Study Risk Control Measures  
The following will be done to mitigate risks associated with the implanted system: 
• Investigators who are experienced with spinal cord stimulation implantation techniques 
will be utilized 
• Instructions will be given to the study participants to ensure they can properly use the 
patient programmer and recharger system 
• Subjects can turn off stimulation at any time during the study with the patient 
programmer or recharger 
• Periodic monitoring of the study participants 
• Written materials that contain precautions, warnings, and contraindications, as well as 
instructions on the use of the devices will be available and/or provided to the clinicians 
and subjects 
Since the efficacy measure in this study is intensity of pain in the back and legs, pain in these 
areas does not need to be reported as an adverse event unless it meets the definition of a serious 
adverse event. However, Investigators may, at their discretion, report any other pain-related 
adverse events during the study.   
C2.  Minimization of Risks 
Neurostimulation therapies, such as SCS, are used as an aid in the management of chronic, 
intractable pain that cannot be effectively managed with medications and/or other conservative 
treatments alone. Patients considered for neurostimulation therapy have typically had pain of 
long duration and have failed multiple therapeutic paths.  
Medtronic has carefully designed and tested the Intellis AdaptiveStim Neurostimulation 
Systems to ensure the safety and performance for the treatment of chronic, intractable pain. 
Medtronic has completed an extensive risk analysis to ensure the identification of potential 
hazards and subsequent mitigation of these hazards to eliminate them entirely or reduce them 
to an acceptable level.   
The risks associated with the surgical implantation of the device, device use, and device failures 
are the same as those observed for commercially available SCS devices. With an existing pre-
market application approval for the commercially available Intellis AdaptiveStim 
Neurostimulation Systems, an established safety profile of probable benefit outweighing risk 
already exists for SCS Therapy for chronic back and/or leg pain. In most cases implantation of 
SCS is a reversible procedure and the system can be turned off or removed. Moreover, 

 
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stimulation parameters are adjustable to minimize or reverse complications and maximize 
therapeutic effects. System output and programming parameters used with the proposed 
stimulation parameters are within the range of the commercially available Intellis AdaptiveStim 
Neurostimulation Systems. The anticipated benefits of the clinical outcomes of SCS therapy 
per the study design outweigh the overall risk. 
Study Investigators are experienced in the diagnosis and treatment of chronic pain, have proper 
surgical and clinical training and will take adequate steps to ensure subject safety throughout 
the entire study.   
Investigators and study personnel will receive product training to become familiar with the 
components of the IntellisTM SCS systems and their functions. They will also receive training 
on assessment tools.  All Investigators and study personnel must provide evidence of training 
in Good Clinical Practice (GCP) in the conduct of clinical trials with human participants.  
D.  Description of the Device 
D.1.  Each Important Component, Ingredient, and Property of the Device 
 
D.1.1.  Device System Overview 
The Intellis™ system is a totally implantable spinal cord stimulation system that is 
indicated to aid in the management of chronic intractable pain of the trunk and/or limbs. 
The system has been approved by the FDA and is available for commercial use. 
The Intellis system system consists of a rechargeable implantable neurostimulator (INS) 
with 16 output channels.  The INS is implanted in a subcutaneous pocket and is capable 
of stimulating the dorsal aspect of the spinal cord when used with one or two 8-contact 
percutaneous leads located in the epidural space.  The INS can be controlled by a Patient 
Programmer and/or a Clinician Programmer.   
Before permanent implantation, a trial phase of therapy lasting up to 10 days is required. 
Components of the system during trial include an External Neurostimulator (ENS) 
capable of delivering the same stimulation as the INS, and Stimulation Leads. Other 
components of the system include Clinician Programmer, Communicator, Patient 
Programmer, Extensions, Charger and charging system, and surgical accessories. 
 
D.1.2.  Device System Details  
 
 
 
Only FDA approved, commercially available components will be used for the study and 
used in a maner that is consistent with approved labeling. 
 
D.1.2.1  Major Components 
Implantable Neurostimulator: Intellis neurostimulator (Model 97715, Medtronic, 
Minneapolis MN) will be used for the study. The INS is a multi-programmable, 
rechargeable device that delivers stimulation through one or two 8-electrode 
percutaneous leads. The stimulation settings are stored in programs. A program is a 
specific combination of pulse width, rate, and amplitude settings acting on a specific 
electrode combination (up to 16 electrodes per program).  Each of the 16 electrodes in 

 
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the leads can be set to be a cathode, an anode, or to remain off.  The INS is powered by 
a Li-Ion rechargeable battery.  The INS is capable of stimulating the dorsal aspect of 
the spinal cord through the electrodes in the leads that are connected to the output 
terminals of the INS. The electrical pulses used for stimulation are generated using a 
single current source.  The INS is designed to produce charge-balanced, biphasic 
rectangular pulses.  
The battery is recharged using an external charger that uses transcutaneous RF energy 
transmission. The INS is capable of communicating with the Charger to control the 
recharging function.   
The INS communicates with the Clinician Programmer and Patient Programmer (also 
called Patient Remote Controller). Clinician Programmer is used to program the INS 
and the ENS. The Patient Programmer is used by the subject to control some of the 
therapy parameters, change therapy programs, and turn stimulation on and off. 
External Neurostimulator (ENS) for Trial Phase: The Medtronic Model 97725 
Wireless External Neurostimulator (ENS) is part of a neurostimulation system used for 
trial stimulation outside of the operating room. The ENS is powered by two standard 
alkaline AAA batteries. The ENS is connected to leads implanted in the subject. The 
subject uses the ENS during the Trial Phase to evaluate the effectiveness of SCS 
therapy prior to receiving a permanent implant. The ENS also communicates with the 
Clinician Programmer system and Patient Remote Controller, similar to the INS.  
Clinician Programmer System:  The Medtronic Model A710 Intellis™ clinician 
programmer application resides on a tablet and is intended to be used by healthcare 
professionals to program the ENS (Model 97725) and IntellisTM INS (Model 97715 and 
97716) for pain therapy. The Clinician Programmer requires the use of the 
Communicator (Model 8880T2) to communicate with the INS.  
Patient Programmer: The Patient Programmer (Model 97745), also called Patient 
Remote Controller, is a handheld unit able to communicate with the INS or ENS.  The 
Patient Programmer is powered by two standard AA alkaline batteries (during trial) or 
a rechargeable battery (after permanent implantation). The Patient Programmer is used 
by subjects to select the SCS therapy program to be applied, to turn on or off the INS 
or ENS, and to change some of therapy parameters such as stimulation amplitude.   
Charging System:  The Charging system (Model 97755) is used by the subject to 
transcutaneously charge the INS battery.  It is a portable device powered by a 
rechargeable battery and can be held in one hand. The charging system used in this 
study is a commercially available charging system manufactured by Medtronic 
(Minneapolis, MN) and fully compatible with the study INS. 
Stimulation Leads and Lead Extensions:  The study will use commercially available 
percutaneous eight-electrode leads manufactured by Medtronic (Minneapolis, MN) and 
compatible with the INS and ENS to be used in this study. The leads are positioned 
percutaneously in the epidural space of the subject and are used for delivering the 
stimulation field to the dorsal aspect of the spinal cord. The percutaneous leads are 
intended to be single use. Temporary or permanent percutaneous leads may be used 
during the Trial Phase of the study. The proximal end of these leads connect directly to 

 
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the ENS. Permanent leads will be used during the Permanent Phase of the study. These 
may be connected to a Lead Extension.  The leads or lead extensions are tunneled 
subcutaneously to connect to the INS. Commercially available lead extensions 
(Medtronic, Minneapolis, MN) compatible with the percutaneous leads and INS may 
be used in this study.  
 
D.1.2.2.  Surgical Accessories 
 
The surgical accessories that will be used in the study will be commercially available 
devices. 
Torque Wrench:  A commercially available Torque Wrench is used to tighten the 
screws that lock a percutaneous lead into the INS and/or a lead extension. It also tighten 
the screws that lock the lead extension into the INS when this is used. 
Lead anchors:  Lead anchors may be used to possibly prevent lead migration and/or 
lead strain. These are used to anchor the percutaneous leads to the supraspinous 
ligament or fascia.  Lead anchors used in this study are commercially available 
(Medtronic, Minneapolis, MN) and designed to slide freely over the lead length to the 
required fixation position. Surgical sutures are then tied around the anchor clamping 
the sleeve in place on the lead.   
Insertion Needle:  Percutaneous leads are implanted in the dorsal epidural space using 
insertion needles.  An insertion needle contains a cannula and stylet that facilitate 
access to the spinal canal for lead placement.  The insertion needle is a 14G epidural 
needle with a thin wall and a modified Touhy non-coring tip.  The cannula and stylet 
are designed to lock together and maintain the orientation of the tip of each component. 
The hub of the insertion needle has a standard luer fitting. 
Stylets:  Stylets are used to push and “steer” a percutaneous lead into the desired place 
within the epidural space.  The distal end of the stylet could be straight or curved.  The 
implanter is able to use either one in order to comfortably maneuver a percutaneous 
lead through the epidural space until it reaches the desired implant location. 
Tunneling Tool:  A Tunneling Tool is used to create a subcutaneous tunnel that directs 
the percutaneous leads or lead extensions from the midline incision to the leads from 
the INS implant site.  This is a single use tool.  
INS Template:  The INS Template is an aid to be used for the implanter intended for 
proper sizing of the INS pocket within each subject. 
INS Port Plug:  An INS Port Plug is used to seal the port of the INS that is not in use 
when only one percutaneous lead is implanted. 
Lead Blank:  A Lead Blank is an optional aid made out of flexible stainless steel that 
has an outer diameter similar in size to the percutaneous lead. A lead blank can be 
optionally used to clear a path for the introduction of a percutaneous lead into the 
epidural space.  
 
 
 

 
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D.2.  Principle of Operation of the Device 
Only commercially approved IntellisTM SCS system will be used according to its indications 
for use.  Spinal cord stimulation therapy for pain management has been used for more than four 
decades. Its efficacy and safety has been widely documented.  
 
D.3.  Labeling 
Instructions for Use:  The study devices will be used in accordance with IntellisTM Manual. 
 
D.4.  Any Anticipated Changes in the Device 
There are no anticipated changes at this time. 
 
E.  Administrative Procedures 
E.1.  Monitoring  
 
Clinical site monitoring is conducted to ensure that the rights and well-being of trial participants 
are protected, that the reported trial data are accurate, complete, and verifiable, and that the 
conduct of the trial is in compliance with the currently approved protocol/amendment(s), and 
with applicable regulatory requirement(s).   
E.1.1.  Study Clinical Monitor 
SGX Nova (sponsor) will assign a Clinical Monitor(s) in order to fulfill the required 
Sponsor and monitoring responsibilities according to the Study Monitoring Plan.  The 
Study Monitoring Plan describes in detail who will conduct the monitoring, at what 
frequency monitoring will be done, at what level of detail monitoring will be performed, 
the distribution of monitoring reports, and key monitoring activities and specifies the data 
to be reviewed over the course of the clinical study. The monitoring plan will facilitate 
compliance with Good Clinical Practices (GCP) and other relevant guidelines. The 
clinical study monitors will conduct monitoring visits in accordance with this plan.  
 
E.1.2. Monitoring Procedures 
Monitoring visits to the clinical investigational sites will be made on-site periodically and 
according to the monitoring Plan.  These visits will ensure that Investigators and their 
staff understand and accept their defined responsibilities, assess compliance with current 
GCP guidelines, evaluate clinical trial progress, assess the continued acceptability of the 
site facilities, evaluate compliance with this investigational plan, and verify the data 
entered on the eCRFs. Remote monitoring visits may also be made periodically.  

 
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Investigators are to maintain, in an appropriate secure location, all source documents as 
required by the investigational plan. Source documents include signed informed consents. 
subject completed questionnaires, laboratory results, supporting medical records, 
supporting study worksheets and any applicable electronic files.  These source documents 
will be used by the Clinical Monitor at the scheduled monitoring visits to verify 
information entered into the EDC System. Clinical monitoring activities will include 
review and resolution of missing or inconsistent results to assure the accuracy of the 
reported data.  Where any discrepancies are noted, the Clinical Monitor will generate 
queries. Discrepancies will be resolved with the Investigator and/or an individual 
designated by the Investigator.  If data is incomplete, the Investigator will attempt to 
obtain the missing data.  The original source documents will remain stored in a secure 
location at the clinical sites as designated by the Investigator.   
The safety and welfare of study subjects will be ensured by following the appropriate 
GCP guidelines for informed consent, including proper documentation (Informed 
Consent Form) by following the investigational plan, and by reporting and following up 
study-related adverse events as appropriate. 
The Clinical Monitor will summarize the evaluation and assessment of each monitoring 
visit in written reports. These reports will identify any issues with repeated data recording 
or reporting and will specify clear recommendations for resolution of noted deficiencies. 
The conduct and monitoring of the clinical investigation will be conducted in accordance 
with sponsor’s internal procedures.   
 
E.2.  Data Quality Assurance 
Data collection is the responsibility of the clinical trial staff at the site under the supervision of 
the site investigator. The investigator is responsible for ensuring the accuracy, completeness, 
legibility, and timeliness of the data reported. The subject data will be entered into an electronic 
data capture system (EDC) system following the study visits. Paper copies of the study visit 
worksheets will be provided for use as source document worksheets for recording data for each 
participant enrolled in the study.  All source documents should be completed in a neat, legible 
manner to ensure accurate interpretation of data. Data recorded in the electronic case report 
form (eCRF) should be consistent with the data recorded on the source documents. Data will 
be reviewed to identify inconsistent or missing data as well as potential study-related adverse 
events.  Data discrepancies will be addressed by written communication or by telephone with 
the clinical site and/or during clinical site monitoring visits. The sponsor and representatives of 
regulatory authorities are permitted to access study documents (e.g. investigational plan, 
eCRFs, medical records/files) as needed. All attempts will be made to preserve the privacy and 
confidentiality of subjects. 
 
E.3. Study Conduct 
The Investigator agrees that the study will be conducted according to this investigation plan, 
the principles of GCPs as outlined in the United States Code of Federal Regulations (CFR) - 21 
CFR Parts 50, 56 and 812, and the Sponsor internal standard operating procedures.  The 

 
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Investigator will conduct all aspects of the study in accordance with all Federal and local laws 
of pertinent regulatory authorities.  
The Investigator will assure correct implementation and conduct of the trial including those 
study related duties delegated to other appropriately qualified individuals and designated in the 
delegation of authority documentation.  The Investigator will assure that study staff cooperates 
with monitoring and audits, and will demonstrate due diligence in recruiting, screening, and 
retaining study subjects. 
The Investigator will also be responsible for filing an annual study progress report to the IRB 
as per IRB guidelines. The Investigator and/or Sponsor, as required by local regulations, are 
required to report in writing to the IRB, notice of completion, termination, or discontinuation 
of the study. If the study is discontinued for safety concerns, the Investigator and/or Sponsor 
will notify the IRB immediately.  
The Investigator is also responsible for recording and assessing the relationship to the study and 
the seriousness of Adverse Events. Investigators must report any study related serious adverse 
event (SAE) to the sponsor within 48 hours of knowledge of the event and to the IRB as per 
their regulations. 
The Investigator is also responsible for promptly reporting to the Sponsor any deviations and 
exceptions to this investigational plan and to the IRB per their requirements. 
 
E.4.  Informed Consent Materials 
Informed consent must be obtained from all subjects prior to study participation.  Informed 
consent will be obtained by the Investigator or an Investigator-designated healthcare 
professional as per GCP guidelines.  An informed consent form (ICF) will be provided to 
potential subjects for their private evaluation. If a subject consents to participate, the ICF must 
be signed by the subject or a legally authorized representative of the subject.  Study ICF must 
be approved by the IRB. Signed ICFs will be retained in the subject's study records at the 
clinical site. Subjects may be consented via a combination of mail and telephone calls. The RC 
will document the telephone calls and follow-up by signing the consent once the subject returns 
the signed consent. The RC will then provide a photo copy to the subject.  
The ICF will be in compliance with the requirements set forth in 21 CFR 50, Protection of 
Human Subjects. 
 
E.5 Investigators and Institutions 
The clinical Investigators participating in this study will be chosen based on their qualifications 
and experience.   
 
E.6. Amendments and Deviations 
This investigational plan is to be followed by Investigators and all personnel involved in the 
clinical study.  Any changes to the study covered by this investigational plan must be 
documented on a formal investigational plan amendment prior to implementation in the study.  

 
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Changes to the investigational plan may be initiated by the sponsor or at the request of an 
Investigator.  A formal change to this study under this investigational plan cannot be initiated 
by Investigator or clinical site personnel without sponsor’s approval, IRB approval, and the 
Investigator’s approval. 
Exception for Emergency Deviation:  An exception to the policy noted 
above is an emergency deviation to the investigational plan which may be 
initiated by the Investigator without prior approval from sponsor only in 
cases where a change is necessary to eliminate any immediate apparent 
hazard to subjects.  Emergency deviations must be reported to the Sponsor 
and the IRB no later than 24 hours following the emergency. 
Deviations from the investigational plan and study requirements (including GCP guidelines) 
will be reviewed by the sponsor and will be evaluated on an ongoing basis. Appropriate 
corrective actions will be implemented as necessary. 
 
E.7. Additional Record and Reports 
This study will be registered on clinicaltrials.gov.  Sponsor/Investigator Records and Reports 
will be maintained and provided in accordance to 21 CFR 812.140 and 812.150.  No additional 
records or reports will be maintained. 
 
 
 

 
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F.  Appendices 
 
A. Informed Consent Form 
B. Subject Questionnaires 
 
 
 

 
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G.  References 
 
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Research. Washington (DC): National Academies Press (US), 2011, pp. 2. 
3 https://www.hhs.gov/opioids/about-the-epidemic/index.html 
4 Weinstein, J.N., et al., Surgical versus nonoperative treatment for lumbar spinal stenosis four-
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p. 1329-38. 
5 Chen, E., K.B. Tong, and M. Laouri, Surgical treatment patterns among Medicare beneficiaries 
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6 Ragab, A. and R.D. Deshazo, Management of back pain in patients with previous back surgery. 
Am J Med, 2008. 121(4): p. 272-8 
7 Yoshihara H, Yoneoka D. National trends in the surgical treatment for lumbar degenerative 
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8 Bae HW, Rajaee SS, Kanin LE. Nation-wide trends in the surgical management  of lumbar 
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12 Deer TR, Mekhail N, Provenzano D, et al. The appropriate use of neurostimulation of the 
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15 Taylor RS, Ryan J, O’Donell R, Eldabe S, Kumar K, North RB. The cost-effectiveness of 
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