A Prospective, Multicenter, Single-arm Study Examining ECAP-controlled, Closed-loop Stimulation With the Evoke Spinal Cord Stimulator (SCS) System to Treat Patients With Chronic Pain of the Trunk and/or Limbs
Phase: NA
Conditions: Chronic Pain, Back Pain, Pain
Sponsor: Saluda Medical Pty Ltd



ECAP Clinical Study Protocol 
 
 
 
 
 
 
          
 
 
Saluda Medical Americas, Inc. 
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CLIN-PCL-006732 
TABLE OF CONTENTS 
 
1 
CLINICAL PROTOCOL SUMMARY ............................................................................................... 5 
2 
BACKGROUND (REPORT OF PRIOR INVESTIGATIONS) .......................................................... 6 
2.1 
Disease Summary .................................................................................................................. 6 
2.2 
Current Treatment Options ..................................................................................................... 6 
2.3 
Rationale for the Proposed Treatment ................................................................................... 7 
2.4 
Summary of Prior Preclinical and Clinical Experience............................................................ 8 
 
 
 
 
2.5 
Rationale for Clinical Study ................................................................................................... 18 
3 
DEVICE DESCRIPTION AND INDICATION FOR USE ............................................................... 18 
3.1 
Device Description ................................................................................................................ 18 
3.1.1 
Investigational Device ................................................................................................... 18 
3.2 
Target Indication for Use ...................................................................................................... 19 
4 
STUDY PURPOSE AND OBJECTIVES ....................................................................................... 19 
4.1 
Study Purpose ...................................................................................................................... 19 
4.2 
Primary Objectives ................................................................................................................ 19 
5 
STUDY DESIGN ........................................................................................................................... 19 
6 
STUDY POPULATION ................................................................................................................. 19 
6.1 
Study Sites ............................................................................................................................ 19 
6.2 
Inclusion Criteria ................................................................................................................... 20 
6.3 
Exclusion Criteria .................................................................................................................. 20 
7 
STUDY ASSESSMENTS .............................................................................................................. 20 
7.1 
Study Pain Assessment ........................................................................................................ 20 
7.2 
Patient Global Impression of Change (PGIC) and Patient Satisfaction................................ 21 
7.3 
PROMIS-29+2 ...................................................................................................................... 21 
7.4 
PROMIS-10 Global ............................................................................................................... 21 
7.5 
Profile of Mood States 2nd Edition – Adult Short (POMS 2-A Short) .................................... 22 
7.6 
Stimulation Characteristics ................................................................................................... 22 
7.7 
Posture Change Measurements ........................................................................................... 22 
7.8 
Neurophysiological Measurements....................................................................................... 22 
7.9 
Programming Parameters and Characteristics ..................................................................... 22 
7.10 
Additional Optional Assessments ......................................................................................... 22 
8 
STUDY PROCEDURES ............................................................................................................... 23 
8.1 
Visit Schedule ....................................................................................................................... 24 
8.2 
Screening/Baseline Evaluation ............................................................................................. 26 
8.3 
Enrollment ............................................................................................................................. 26 
8.4 
Temporary SCS Trial Phase ................................................................................................. 26 
8.5 
Implant Procedure/Post-procedure ....................................................................................... 27 
8.6 
Follow-up Visits ..................................................................................................................... 27 

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8.7 
Programming Sessions ......................................................................................................... 27 
8.8 
Revisions, Replacements, and Explants .............................................................................. 27 
8.9 
Study Exit – Completion and Withdrawal ............................................................................. 27 
8.10 
Concomitant Medications ..................................................................................................... 28 
9 
ADVERSE EVENTS ..................................................................................................................... 28 
9.1 
Adverse Event Definitions ..................................................................................................... 28 
9.1.1 
Adverse Event ............................................................................................................... 28 
9.1.2 
Serious Adverse Event ................................................................................................. 28 
9.1.3 
Unanticipated Adverse Device Effects.......................................................................... 28 
9.2 
Adverse Event Recording and Reporting ............................................................................. 28 
9.2.1 
Adverse Event Recording ............................................................................................. 28 
9.2.2 
Adverse Event Reporting .............................................................................................. 29 
9.3 
Independent Medical Reviewer and/or Adjudication Committee .......................................... 29 
10 
DEVICE DEFICIENCIES .............................................................................................................. 29 
10.1 
Device Deficiency Definitions ............................................................................................... 29 
10.2 
Device Deficiency Reporting ................................................................................................. 29 
11 
STATISTICAL ANALYSIS ............................................................................................................ 30 
11.1 
Sample Size .......................................................................................................................... 30 
11.2 
Study Outcomes ................................................................................................................... 30 
11.3 
General Statistical Procedures ............................................................................................. 30 
11.4 
Timing of Analyses ............................................................................................................... 30 
12 
RISK ANALYSIS ........................................................................................................................... 30 
12.1 
Potential Risks ...................................................................................................................... 30 
12.2 
Minimization of Risks ............................................................................................................ 31 
12.3 
Potential Benefits .................................................................................................................. 31 
12.4 
Benefit-Risk Conclusions ...................................................................................................... 31 
13 
STUDY ADMINISTRATION .......................................................................................................... 32 
13.1 
Study Materials ..................................................................................................................... 32 
13.1.1 
Packaging and Labeling ............................................................................................... 32 
13.1.2 
Handling and Storage ................................................................................................... 32 
13.1.3 
Product Accountability .................................................................................................. 32 
13.2 
Ethics .................................................................................................................................... 32 
13.2.1 
Institutional Review Board Approval ............................................................................. 32 
13.2.2 
Informed Consent ......................................................................................................... 32 
13.2.3 
Subject Confidentiality .................................................................................................. 33 
13.3 
Data and Quality Management ............................................................................................. 33 
13.3.1 
Data Collection and Management ................................................................................ 33 
13.3.2 
Monitoring ..................................................................................................................... 33 
13.3.3 
Audits/Inspections ......................................................................................................... 33 
13.4 
Access to Study Records ...................................................................................................... 34 

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13.5 
Investigation Site and Subject Training ................................................................................ 34 
13.5.1 
Pain Assessment Training ............................................................................................ 34 
13.6 
Investigator Responsibilities ................................................................................................. 34 
13.7 
Investigator Agreement and Financial Disclosure ................................................................ 34 
13.7.1 
Investigator Records ..................................................................................................... 35 
13.7.2 
Investigator Reports ...................................................................................................... 35 
13.8 
Sponsor Responsibilities ...................................................................................................... 36 
13.8.1 
Sponsor Representatives ............................................................................................. 36 
13.9 
Deviations to the Protocol ..................................................................................................... 36 
13.10 Amendments to the Protocol ................................................................................................ 36 
13.11 Completion, Early Termination, or Suspension of the Study ................................................ 37 
13.12 Record Retention .................................................................................................................. 37 
13.13 Clinical Trials Registry/Database (ClinicalTrials.gov) ........................................................... 37 
13.14 Publication ............................................................................................................................ 37 
 
ABBREVIATIONS AND ACRONYMS .................................................................................................. 39 
BIBLIOGRAPHY ................................................................................................................................... 41 
 
 
 
 
 
 
 
 

ECAP Clinical Study Protocol 
 
 
 
 
 
 
          
 
 
Saluda Medical Americas, Inc. 
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CLIN-PCL-006732 
1 
CLINICAL PROTOCOL SUMMARY 
Title 
ECAP Study: A prospective, multicenter, single-arm study examining ECAP-
controlled, closed-loop stimulation with the Evoke Spinal Cord Stimulator (SCS) 
System to treat patients with chronic pain of the trunk and/or limbs. 
Investigational 
Device 
Evoke Spinal Cord Stimulator (SCS) System (Evoke System) 
 
The Evoke System measures and records spinal cord (SC) activation resulting from 
stimulation via evoked compound action potentials (ECAPs).  The Evoke System can 
be programmed to provide ECAP-controlled, closed-loop SCS or open-loop, fixed-
output SCS; ECAPs may be measured and recorded in either stimulation mode. 
Target Indication for 
Use 
The Evoke System is indicated as an aid in the management of chronic, intractable 
pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the 
following: failed back surgery syndrome, intractable low back pain and leg pain. 
Purpose 
The purpose of this study is to evaluate neurophysiological measures and clinical 
outcomes of the Evoke System to treat trunk and/or limb pain in a real-world 
population.  
Study Design 
This study is a prospective, multicenter, single-arm study. Data will be collected at 
baseline, time of procedure (trial and permanent), trial phase, and at 1, 3, 6, 12, 
18, and 24 months post-implantation. 
Primary Objective 
The primary objective of this study is to collect data in a real-world population while 
further characterizing neurophysiological measures and clinical outcomes.  
Statistical Analysis  
A number of outcome variables of interest will be collected and assessed across study 
visits. No pre-planned formal statistical hypothesis tests will be performed.  
Multivariable regression modeling and descriptive statistics will be utilized.    
Data Collection 
The following data will be collected:  
x 
Baseline characteristics and demographics 
x 
Procedure characteristics 
x 
Medications 
x 
Study Pain Assessment  
x 
PROMIS-29+2  
x 
PROMIS-10 Global  
x 
Profile of Mood States (POMS 2-A Short)  
x 
Patient Global Impression of Change (PGIC) and Patient Satisfaction 
x 
Stimulation characteristics 
x 
Posture change measurements 
x 
Neurophysiological measurements 
x 
Programming parameters and characteristics 
x 
Safety (adverse events, device deficiencies, protocol deviations) 
Inclusion Criteria 
Subjects enrolled in this study must meet all of the following inclusion criteria (based 
on investigator judgement): 
1. Subject has chronic intractable pain of the trunk and/or limbs (VAS ≥6 cm in at 
least one of the regions intended to be treated with SCS). 
2. Subject is willing and capable of giving informed consent and able to comply 
with study-related requirements, procedures, and visits. 
3. Subject has trunk and/or limb pain such that lead placement will be in the 
lumbar to cervical region. 
Exclusion Criteria 
Subjects enrolled in this study must not meet any of the following exclusion criteria 
(based on investigator judgement):  
1. Subject is unable to operate the system. 
2. Subject is an unsuitable surgical candidate.  
3. Subject has a condition currently requiring or likely to require the use of 
diathermy.  
4. Subject has another implantable stimulator such as demand type pacemakers 
or cardioverter defibrillator. 
5. Subject is <18 years old. 
6. Subject is pregnant or nursing. 

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7. Subject is allergic, or has shown hypersensitivity, to any materials of the 
neurostimulation system which come in contact with the body. 
8. Subject is involved in an injury claim under current litigation or has 
pending/approved worker’s compensation claim. 
9. Subject has prior experience with SCS. 
10. Subject is being treated with electroconvulsive therapy (ECT) or transcranial 
magnetic stimulation (rTMS). 
Investigation Sites 
Up to 25 US sites. 
Enrollment 
Up to 300 subjects (enrollment defined as trial procedure). 
Enrollment is anticipated to take 36 months. 
 
2 
BACKGROUND (REPORT OF PRIOR INVESTIGATIONS) 
2.1 
Disease Summary 
Chronic pain is one of the most common reasons for medical care resulting in one of the largest and 
costliest medical health problems in the developed world and it is likely to worsen(1–3).  Chronic pain 
persists well after the initial injury or illness that produced the initial pain has healed. The International 
Association for the Study of Pain (IASP) has defined chronic pain as pain that lasts more than three to 
six months beyond the normal time of healing(4). Chronic pain invariably is generated by physical, 
psychological, and environmental factors (bio-psycho-social concept of chronic pain). It is difficult to 
manage, and many afflicted patients have a florid medical history with multiple comorbidities. Chronic 
pain is also difficult to generally define beyond its chronicity. Chronic pain is routinely characterized by 
multiple aspects including: the nature of the pain as perceived and reported (e.g. nociceptive, 
neuropathic, ischemic), the pathophysiology causing the pain (e.g., painful diabetic neuropathy), or the 
anatomical location that the pain is perceived (e.g., chronic low back pain), or a combination of these 
(e.g., discogenic low back pain). The published Classification of Chronic Pain, Descriptions of Chronic 
Pain Syndromes and Definitions of Pain Terms from IASP lists around 100 separately identifiable chronic 
pain conditions(4).   
2.2 
Current Treatment Options  
The multifaceted nature of chronic pain requires interdisciplinary assessment and multimodal treatment. 
First line treatment strategies are generally conservative treatments including: exercise programs, 
physical therapy (PT), occupational therapy, cognitive behavioral therapy (CBT), biofeedback, 
acupuncture, transcutaneous electrical nerve stimulation (TENS), and oral medications. Second line 
treatments become more intensive and involve the use of more extreme CBT, more powerful 
medications such as systemic opioids, and interventional techniques such as nerve blocks (local 
anesthetic or steroids) and spinal injections. The last line of treatment involves more advanced therapies 
that require surgical interventions. Systems such as intrathecal drug delivery (IDD) or spinal cord 
stimulators (SCS) may be implanted. Surgery to repair an anatomical issue responsible for the pain may 
be performed. Finally, surgical techniques that block pathways to the brain such as cordotomy, 
rhizotomy, and thalamotomy may be used rarely in extreme cases. 
 
Recent guidelines and the literature on the treatment for chronic pain of the trunk and/or limbs 
demonstrate that each of the surgical interventions have the potential to be effective in managing pain, 
increasing patient activity, and to result in high patient satisfaction when conservative treatment 
modalities have failed. The risk profile for SCS therapy has advantages compared to surgical revision 
and neuroablation due to the fact it is reversible as the device can be surgically removed.  Furthermore, 
typically patients undergo a trial period with SCS, in which leads are temporarily placed in the epidural 
space and connected to an external pulse generator, to assess tolerability and the degree of pain relief 
prior to being permanently implanted.  The Neuromodulation Foundation recommends that an SCS trial 
precede major reconstructive procedures and ablative therapies (5). In addition, SCS therapy has the 

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advantage of not having drug side effects, including respiratory distress, as compared to IDD systems, 
or addictive properties, as compared to opioid usage, which is currently of epidemic proportions in the 
United States (US).  There is consensus among national medical societies to recommend SCS as a 
treatment option in patients with chronic, severe pain for which conservative treatment modalities have 
failed or are contraindicated(5–13).  SCS may be delivered in parallel with other therapies and should 
be used as part of an overall multimodal treatment strategy. 
2.3 
Rationale for the Proposed Treatment  
SCS is a well-established therapy with a long history of use in treating chronic intractable pain of the 
trunk and/or limbs.  SCS consists of applying an electrical stimulus to the spinal cord which causes the 
activated fibers (e.g., Aβ-fibers) to generate action potentials.  Aβ-fibers are the low-threshold sensory 
fibers in the dorsal column that contribute to inhibition of pain signals in the dorsal horn (14).  The action 
potentials summed together form the electrically evoked compound action potential (ECAP). Therefore, 
ECAPs are a direct measure of spinal cord fiber activation that generates pain inhibition for an individual.  
 
The original SCS device consisted of an implanted radiofrequency-controlled power source connected 
to two electrodes (Shealy et al. 1967).  Over the last 50 years there have been many advances in SCS 
therapy, including a better understanding of the target patient population and improvements in device 
technology and reliability. The technology has evolved from large profile, single channel, non-
rechargeable implantable pulse generators (IPG) and monopolar leads, to smaller profile, multichannel, 
rechargeable IPGs with new programming parameters and multiple contact leads with various electrode 
arrays. 
 
A significant challenge that still remains in SCS, however, is the ever-changing distance between the 
stimulating electrodes relative to their spinal cord target. The electrode is fixed in the epidural space, 
while the spinal cord changes position within the cerebrospinal fluid with every movement, including the 
cardiorespiratory cycle (e.g., breathing, heartbeat), coughing, or changes in body position (e.g., standing, 
sitting, lying). Small changes in distance between the electrode and spinal cord result in large changes 
in the current reaching the spinal cord, as the current density with SCS varies with the inverse of the 
distance between the electrode and spinal cord squared (15). Thus, at a fixed SCS output level, the 
degree of spinal cord (SC) activation varies widely.  
 
Currently available SCS systems, regardless of the stimulation parameters, are open-loop systems and 
incapable of measuring SC activation or varying stimulation output based upon such measurement. For 
these systems, the stimulation is fixed based on in-clinic programmed settings. There is a feed-forward 
system (16) with an accelerometer located in the pulse generator, distant from the electrode to spinal 
cord interface, that utilizes pre-programmed, fixed output stimulation programs based on gross postural 
changes (17). In all cases, however, the stimulation output does not vary based upon how much current 
is reaching the spinal cord, which can result in significant variation in SC activation. To manage variance 
in stimulation, patients generally reduce the stimulation amplitude using a remote control, which 
improves tolerability of stimulation and reduces the incidence of overstimulation, but also reduces the 
amount of analgesia that can be achieved (18).  
 
To address these limitations, the Evoke System has been developed that is able to record in vivo human 
spinal cord electrophysiology continuously in real time (19,20). An ECAP is measured for each 
stimulation pulse delivered; this reflects the degree of SC activation elicited by SCS. The system may 
operate in fixed-output, open-loop (plus ECAP measurement) or ECAP-controlled, closed-loop mode. In 
open-loop SCS, the system measures ECAPs, which may be used to determine optimal stimulation 
settings, but are not used to automatically adjust stimulation current to maintain a target response. In 
closed-loop SCS, the difference between the measured ECAP and the target ECAP amplitude is 
minimized by automatically adjusting the stimulation current to maintain consistent SC activation within 
the individuals’ therapeutic window. By real-time modulation of the output current, the closed-loop system 

ECAP Clinical Study Protocol 
 
 
 
 
 
 
          
 
 
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CLIN-PCL-006732 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 

ECAP Clinical Study Protocol 
 
 
 
 
 
 
          
 
 
Saluda Medical Americas, Inc. 
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CLIN-PCL-006732 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ECAP Clinical Study Protocol 
 
 
 
 
 
 
          
 
 
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CLIN-PCL-006732 
adjusting the stimulation current for every stimulus.  In doing so, it maintains spinal cord activation near 
the target level (Figure 1).  The system is designed to operate in either ECAP-controlled, closed-loop 
stimulation mode, or open-loop (fixed-output) stimulation mode equivalent to other commercially 
available SCS systems.  ECAPs may be measured and recorded in either stimulation mode. 
 
 
 
Figure 1: Feedback Mechanism – ECAP-Controlled, Closed-Loop SCS 
3.2 
Target Indication for Use 
The Evoke System is indicated as an aid in the management of chronic intractable pain of the trunk 
and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery 
syndrome, intractable low back pain and leg pain. 
4 
STUDY PURPOSE AND OBJECTIVES 
4.1 
Study Purpose 
The purpose of this study is to evaluate neurophysiological measures and clinical outcomes of the Evoke 
System to treat trunk and/or limb pain in a real-world population. 
4.2 
Primary Objectives 
The primary objective of this study is to collect data in a real-world population while further characterizing 
neurophysiological measures and clinical outcomes. 
5 
STUDY DESIGN 
This study is a prospective, multicenter, single-arm study designed to examine ECAP-controlled, closed-
loop stimulation with the Evoke System to treat patients with chronic pain of the trunk and/or limbs.   
 
Subjects with chronic, intractable pain of the trunk and/or limbs will be screened for participation in this 
study.  Subjects who provide informed consent and meet the study eligibility criteria undergo a trial 
procedure and will be enrolled.  Following the trial phase subjects may receive a permanent implant and 
be followed up at 1-, 3-, 6-, 12-, 18-, and 24-months following the permanent implant.       
6 
STUDY POPULATION 
6.1 
Study Sites 
Study subjects will be enrolled at up to 25 US sites. 

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6.2 
Inclusion Criteria 
Subjects enrolled in this study must meet the following inclusion criteria, as determined by the 
Investigator:  
 
1. Subject has chronic intractable pain of the trunk and/or limbs (VAS ≥6 cm in at least one of  the 
regions intended to be treated with SCS). 
 
2. Subject is willing and capable of giving informed consent and able to comply with study-related 
requirements, procedures, and visits. 
 
3. Subject has trunk and/or limb pain such that lead placement will be in the lumbar to cervical 
region. 
6.3 
Exclusion Criteria 
Subjects enrolled in this study must not meet the following exclusion criteria, as determined by the 
Investigator: 
 
1. Subject is unable to operate the system. 
 
2. Subject is an unsuitable surgical candidate. 
 
3. Subject has a condition currently requiring or likely to require the use of diathermy. 
 
4. Subject has another implantable stimulator such as demand type pacemakers or cardioverter 
defibrillator. 
 
5. Subject is <18 years old. 
 
6. Subject is pregnant or nursing. 
 
7. Subject is allergic, or has shown hypersensitivity, to any materials of the neurostimulation 
system which come in contact with the body. 
 
8. Subject is involved in an injury claim under current litigation or has pending/approved worker’s 
compensation claim. 
 
9. Subject has prior experience with SCS. 
 
10. Subject is being treated with electroconvulsive therapy (ECT) or transcranial magnetic 
stimulation (rTMS). 
7 
STUDY ASSESSMENTS 
7.1 
Study Pain Assessment 
The Study Pain Assessment includes the following:  
 
x 
A body map drawing for subjects to shade in the areas of the subject’s pain that are intended to 
be treated with SCS (i.e., “study pain”).  The Investigator will review the pain map with the subject 
and identify which are the pain locations intended to be treated with SCS and which are not. 
 
x 
A Visual Analogue Scale (VAS) to rate study pain intensity for each region shaded as having 
study pain on the body map. The VAS consists of a 10 cm line with two end-points representing 
“no pain” and “worst pain imaginable”. Subjects are asked to rate their pain by placing a mark 

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on the line corresponding to their level of pain. The distance along the line from the “no pain” 
end to the subject’s mark is measured.   
 
x 
Questions regarding the quality and nature of the subjects’ study pain and sleep. 
 
x 
At Baseline only: 
 
o 
Douleur Neuropathique 4 Questions (DN4), which is a screening tool for neuropathic 
pain with 10 items split across four questions regarding the subjects’ study indication 
pain.  Seven items related to pain quality (i.e. sensory and pain descriptors) are based 
on an interview with the patient and 3 items are based on the clinical examination.   
 
o 
Questions regarding the study pain etiology and pathophysiology. 
7.2 
Patient Global Impression of Change (PGIC) and Patient Satisfaction 
Patient Global Impression of Change (PGIC) is a single item measure of global improvement with 
treatment.  The subject is presented with a 7-point rating scale containing the options “very much 
improved”, “much improved”, “minimally improved”, “no change”, “minimally worse”, “much worse”, and 
“very much worse”.   
 
Subject recommendation of and satisfaction with the stimulation therapy and study pain relief will also 
be collected.  Recommendation options include “strongly recommend,” “recommend,” “neutral,” “not 
recommend,” and “definitely not recommend.”  Satisfaction options include “very satisfied,” “satisfied,” 
“neither satisfied nor unsatisfied,” “unsatisfied,” and “very unsatisfied.”   
7.3 
PROMIS-29+2 
The PROMIS-29+2 consist of the PROMIS-29 profile (v2.1) and two PROMIS Cognitive Function 
Abilities items. The PROMIS-29 is a 29-item profile instrument that assesses 8 universal domains (not 
disease-specific): Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to 
Participate in Social Roles and Activities, Pain Interference, and Pain Intensity. The first seven 
domains are assessed with 4 questions each; Pain Intensity is measured with a single 11-point 
numeric rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain). High scores represent more 
of the domain being measured. Thus, on symptom-oriented (negatively-worded) domains of PROMIS-
29 (anxiety, depression, fatigue, pain interference, and sleep disturbance), higher scores represent 
worse symptomatology. On the function-oriented (positively-worded) domains (physical functioning and 
social role) higher scores represent better functioning. The addition of the two items from the PROMIS 
Cognitive Function Abilities, for a total of 31 questions, allows for incorporation of the PROMIS 
Preference Scoring System (PROPr), which is a generic societal, preference-based summary score 
(also called a health utility score). The PROPr is measured on scale where 0 is the utility of being dead 
and 1 the utility of “full health.” The lowest possible score is –0.022 (for a state viewed as worse than 
dead), and the highest possible score is 1.  
 
7.4 
PROMIS-10 Global 
The PROMIS Global Health measure produces two scores: Physical Health and Mental Health. PROMIS 
Global includes 10 items: four items that reflect different aspects of physical health (e.g., fatigue, physical 
function, pain) contribute to a Global Physical Health score, and four items that reflect different aspects 
of mental health (e.g., mood, cognition, social activities/role) contribute to a Global Mental Health score. 
A change in Global Physical Health may be the result of a change in fatigue, physical function, or other 
domain of physical health. The scores present a summary of multiple aspects of health. Higher PROMIS 
T-score represents more of the concept being measured. Thus, a person who has T- scores of 60 for 
the Global Physical Health or Global Mental Health scales is one standard deviation better (more healthy) 
than the general population. 

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7.5 
Profile of Mood States 2nd Edition – Adult Short (POMS 2-A Short) 
The Profile of Mood States 2nd Edition – Adult Short (POMS 2-A Short) is a 35 item, 5-point Likert scale 
that measures mood states overall (Total Mood Disturbance) as well as for six mood clusters: Tension-
Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-
Bewilderment. A scale score is also calculated for Friendliness, which is considered separately as a 
mood state that may influence the severity of the mood disturbance through interpersonal functioning.  
Higher scores indicate more negative mood states except for Vigor-Activity where higher scores indicate 
increased Vigor. 
7.6 
Stimulation Characteristics 
Subjects will be asked questions about stimulation sensation and to shade in the areas where they 
typically experience stimulation sensation on a body map drawing.   
7.7 
Posture Change Measurements 
Data on stimulation intensity and ECAP amplitude at various stimulation levels (i.e., activation plot) and 
in different postures will be collected in both stimulation modes.  Subjects will rate the stimulation intensity 
on an 11-point numeric rating scale (0 equals “no feeling” and 10 equals “very intense”).  All data will be 
recorded on device logs, except subject ratings, which will be recorded on the CRF. 
7.8 
Neurophysiological Measurements  
Neurophysiological measurements of the stimulated fibers (e.g., ECAP features, conduction velocity, 
chronaxie, rheobase, late responses) will be collected.  Data is automatically recorded on the device 
logs.  
7.9 
Programming Parameters and Characteristics 
Program parameters (e.g., frequency, pulse width, stimulation amplitude) and characteristics (e.g., 
usage) will be collected.  Data is automatically recorded on the device logs. 
7.10 Additional Optional Assessments  
Optional assessments to collect additional data may be requested that subjects can elect to participate 
in.  Potential assessments include (but are not limited to):  
x 
Medication interaction: Additional neurophysiological data may be collected during changes in 
medication to measure the effect of medications on spinal cord activation. Subjects may be 
requested to return to original doses of medications temporarily during this time.  For example, 
if a subject is tapering medications, they may be asked to record their daily intake and return to 
the clinic for additional visits to collect neurophysiological measurements and optimize their 
stimulation therapy during the taper. 
x 
Programming algorithms and dose:  Various programming parameter algorithms and/or various 
levels of therapy or spinal cord activation “dose” may be evaluated.   
x 
Usability: As new or modified products becomes available during the study, questions that 
pertain to the technical capability/performance (usability) of the product(s) may be asked of 
subjects.  
x 
Pain signs/symptoms with stimulation on and/or off (e.g., Neuropathic Pain Symptom Inventory 
(NPSI), Complex Regional Pain Syndrome (CRPS)-specific questions, bedside-Quantitative 
Sensory Testing (bedside-QST)) 
 
These assessments may occur anytime during the study. These optional assessments are in addition to 
the required protocol data collection and there are no foreseeable additional risks to the subject.  If 
additional testing is deemed to have additional risks, the investigator will obtain a separate consent. 
 

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Data will be collected on a CRF and/or the device log files based on the specific requirements. 
8 
STUDY PROCEDURES 

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8.2 
Screening/Baseline Evaluation 
Potential study subjects will be identified and informed of the study.  Subjects who provide informed 
consent for study participation (refer to section 13.2.2) will complete the study-specific baseline 
assessments.  Medical records documenting the condition of the subject, including relevant previous 
medical history and results of diagnostic tests, will be obtained.   Data collected during 
screening/baseline include: 
x 
Determination of subject study eligibility (inclusion/exclusion criteria) 
x 
Demographics, medical history, and physical examination  
x 
Study Pain Assessment (including DN4 and pain etiology/pathophysiology) 
x 
PROMIS-29+2 
x 
PROMIS-10 Global 
x 
POMS 2-A Short 
8.3 
Enrollment 
Subjects who provide informed consent and meet eligibility criteria will be considered enrolled at the 
time of the trial procedure.  
8.4 
Temporary SCS Trial Phase 
Before permanent implant of the Evoke System, subjects will undergo a trial stimulation phase with the 
external stimulator attached to one or two Evoke leads. The procedure will be performed in accordance 
with standard of care and the Evoke IFU.  The device will be programmed for pain coverage in 
accordance with the Evoke IFU. Timing of post-procedure programming will occur at the discretion of 
the Investigator. 
 
The trial will last up to 30 days (typically 1 week) to determine if the subject will proceed to the permanent 
implant. Subjects may have multiple visits during the trial phase in order to optimize stimulation settings.  
The following data will be collected during the trial phase: 
 
Trial Procedure/Post-procedure: 
x 
Trial procedure data 
x 
X-rays (AP and lateral) during the procedure  
x 
Posture change measurements (to be collected at least once post-procedure through Trial End) 
x 
Neurophysiological measurements (to be collected at least once post-procedure through Trial 
End) 
x 
Device programming  
 
Trial End: 
x 
Study Pain Assessment 
x 
PROMIS-29+2 
x 
PROMIS-10 Global 
x 
POMS 2-A Short 
x 
PGIC & Patient Satisfaction 
x 
Stimulation characteristics 
x 
Posture change measurements (to be collected at least once post-procedure through Trial End) 
x 
Neurophysiological measurements (to be collected at least once post-procedure through Trial 
End)  
x 
X-rays (AP and lateral) prior to lead pull  
x 
Lead pull procedure 

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8.5 
Implant Procedure/Post-procedure  
Subjects will be approved to undergo implantation of the Evoke System if the subjects’ trial was 
successful based on physician and subject determination.  
 
The permanent implant will involve the implantation of the Evoke stimulator and one or two Evoke leads. 
The implant procedure will be performed in accordance with standard of care and the IFU, and 
programming will be performed in accordance with the IFU.  Timing of post-procedure programming will 
occur at the discretion of the Investigator, prior to the 1-month follow-up visit.   
 
The following data will be collected during the implant procedure/post-procedure:   
x 
Implant procedure data 
x 
X-rays (AP and lateral) during the procedure  
x 
X-rays (AP and lateral) post-procedure, prior to 1-month follow-up 
x 
Neurophysiological measurements (optional) 
x 
Device programming  
8.6 
Follow-up Visits  
Subjects will be followed-up at 1 month (30, -14 days, +21days), 3 months (90±21 days), 6 months 
(180±30 days), 12 months (365±60 days), 18 months (545±90 days), 24 months (730±90 days).  
Subjects may have their device reprogrammed throughout follow-up.  The following data will be 
collected during follow-up: 
 
x 
Study Pain Assessment  
x 
PROMIS-29+2 
x 
PROMIS-10 Global 
x 
POMS 2-A Short 
PGIC & Patient Satisfaction 
x 
Stimulation characteristics 
x 
Posture change measurements 
x 
Neurophysiologic measurements 
x 
Device programming (as needed) 
8.7 
Programming Sessions 
Device programming will initially occur following the trial and implant procedures. Programming 
adjustments may occur as many times as needed after initial programming (for either the trial or the 
permanent implant) to optimize treatment.  Programming will be performed in accordance with the IFU 
by the Sponsor representative.   
8.8 
Revisions, Replacements, and Explants 
During the study subjects may require a device revision, replacement or explant.  The following data 
will be collected for revisions, replacements, and explants: 
x 
Revision/replacement/explant procedure data 
x 
Adverse Events 
x 
Device deficiencies 
x 
X-rays (as needed) 
x 
Neurophysiologic measurements (optional) 
8.9 
Study Exit – Completion and Withdrawal 
At the end of the subjects’ study participation, either due to study completion or early withdrawal, a 
study exit form will be completed documenting the date and reason for study exit. The study exit form 

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is only required for enrolled subjects. For those subjects who miss a scheduled study visit, the site shall 
attempt to contact the subject at least three times, with at least one attempt being a certified letter, prior 
to considering the subject lost to follow-up (LTF). For subjects who withdraw from the study early, all 
attempts will be made to collect safety data.  
8.10 Concomitant Medications  
Medications will be collected at baseline and changes will be tracked throughout the subjects’ 
participation in the study.  
9 
ADVERSE EVENTS 
9.1 
Adverse Event Definitions 
9.1.1 
Adverse Event 
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, 
or untoward clinical signs in subjects, whether or not related to the investigational medical device. 
9.1.2 
Serious Adverse Event 
A serious adverse event (SAE) is defined as an AE that  
x 
Led to death, 
x 
Led to serious deterioration in the health of the subject, and that either resulted in: 
1. a life-threatening illness or injury, or 
2. a permanent impairment of a body structure or a body function, or 
3. prolonged hospitalization, or 
4. medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function, 
x 
Led to fetal distress, fetal death, or congenital anomaly or birth defect. 
 
Note: Planned hospitalization for a pre-existing condition or a procedure required by the protocol (e.g., 
the index implant procedure, or device replacement due to normal battery depletion or lead migration), 
or a hospitalization without serious deterioration in health, is not considered an SAE. 
9.1.3 
Unanticipated Adverse Device Effects 
An unanticipated adverse device effect (UADE) means any serious adverse effect on health or safety 
or any life-threatening problem or death caused by or associated with a device, if that effect, problem, 
or death was not previously identified in nature, severity, or degree of incidence in the investigational 
plan or application, or any other unanticipated serious problem associated with a device that relates to 
the rights, safety, or welfare of subjects. 
 
An event will not be considered a UADE if it is a known consequence of the underlying disease or 
condition under investigation, surgery, or other events that commonly occur in the study population 
independent of the investigational device. 
 
The final determination of whether an AE meets the definition of a UADE will be made by the 
independent adjudication committee for this study. 
9.2 
Adverse Event Recording and Reporting 
9.2.1 
Adverse Event Recording  
Investigators are responsible for providing a description of all AEs, including the clinical outcome for the 
subject. Investigators will evaluate each event for seriousness, severity, and relatedness to the 
procedure, device, or stimulation therapy. Investigators must supply the Sponsor with any additional 
information related to safety reporting of a particular event.   

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9.2.2 
Adverse Event Reporting 
Investigators are required to report all AEs from the time of consent (except as outlined below). If an 
AE leads to multiple outcomes that sequentially worsen, only the worst AE will be reported. 
 
Investigators shall report AEs to the Sponsor, and to their reviewing IRB per the IRB’s reporting 
requirements. Investigators are required to report UADEs to the Sponsor and their reviewing IRB as 
soon as possible, but in no event later than 10 working days after the Investigator first learns of the 
effect, per 21 CFR 812.150 (refer to section 13.7.2 for Investigator reporting requirements). 
 
AE reporting exceptions: 
x 
AEs that would be reasonably expected to be associated with any surgical procedure (e.g., 
anesthesia associated symptoms, surgical site pain, post-procedure pain) will not be required 
to be reported as AEs unless, in the opinion of the Investigator, the nature and/or severity is 
outside of what is typical for SCS procedures and recovery. 
 
x 
Lack of efficacy, by itself, does not constitute an AE since failure to receive therapeutic benefit 
is an issue of efficacy, not safety. 
  
x 
Loss of therapy/stimulation does not constitute an AE unless an untoward medical occurrence 
results.   
 
x 
A subject’s perception of the stimulation induced feeling of stimulation sensation is called 
paresthesia. There are well-known challenges associated with optimizing SCS such as 
changes in stimulation intensity and stimulation in unwanted areas.  These will not be reported 
as AEs unless the Investigator determines the nature and/or severity is outside what is typical 
for neurostimulation.   
 
x 
Temporary changes in symptoms and stimulation that are alleviated with programming will not 
be reported as AEs unless the Investigator determines the nature and/or severity is outside 
what is typical for neurostimulation.  
9.3 
Independent Medical Reviewer and/or Adjudication Committee 
Independent medical reviewer and/or adjudication committee will be responsible for the review, 
evaluation, categorization, and adjudication of all AEs that occur during the clinical study. AEs will be 
reported based on this adjudication.   
10 DEVICE DEFICIENCIES 
10.1 Device Deficiency Definitions 
A device deficiency is an inadequacy of a medical device with respect to its identity, quality, durability, 
reliability, safety or performance. Device deficiencies include malfunctions, use errors, and 
inadequate labelling. 
10.2 Device Deficiency Reporting 
The Investigator shall report all suspected device deficiencies to the Sponsor. Device deficiencies will 
not necessarily result in an AE. However, if an AE is associated with a device deficiency, the AE shall 
be documented and reported.   

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11 STATISTICAL ANALYSIS 
11.1 Sample Size 
A sample size of 300 will provide a precision (defined as the half-width of the two-sided 95% exact 
binomial confidence interval) of approximately ±6% or smaller for any event based on an incidence of 
50%; an observed lower or higher incidence will produce a more precise (i.e. narrower) interval (25). 
11.2  Study Outcomes 
 
A number of outcome variables of interest will be collected and assessed across study visits to 
characterize neurophysiological measures and clinical outcomes with the Evoke System. 
11.3 General Statistical Procedures  
The following general statistical methods will be employed to assess the study data: 
 
x 
There are no pre-planned formal statistical hypothesis tests. 
 
x 
Standard summary statistics will be used to summarize key study variables. Categorical 
variables will be summarized via incidence and percent. Continuous variables will be 
summarized via mean, median, standard deviation, and range.  
 
x 
Findings of significance may be presented and include p-values and/or 95% confidence 
intervals as appropriate. 
 
x 
Standard tests for significance will be employed, including one sample t-tests.  Additional 
exploratory analyses may be performed and include correlation analysis, linear and logistic 
regression analyses, repeated measures analyses, and generalized estimating equation (GEE) 
analyses as appropriate. 
 
x 
Unless stated otherwise, statistical significance is defined as achieving a p-value less than 0.05.  
P-values will be nominal and not adjusted for multiplicity.  
 
x 
In the event planned parametric methods are found to be inappropriate based upon observed 
distributions of individual variables, appropriate non-parametric methods will be employed. 
 
x 
The incidence of all distinct AEs will be presented. AEs will also be summarized by seriousness, 
severity, and relatedness to the procedure, device, and/or stimulation. AEs will be reported 
based on the adjudication committee determination. 
11.4 Timing of Analyses  
As there are no formal pre-planned hypothesis tests, statistical analyses may be completed at any time.  
Reporting will be completed as required per the regulations and governing IRBs. 
12 RISK ANALYSIS 
12.1  Potential Risks 
Risks associated with the Evoke System are similar to those of other open-loop SCS systems, which 
are generally minor. All medical procedures involve some risk of injury, including death. Other 
anticipated risks associated with the Evoke System are listed in this protocol or found in the literature, 
post-market surveillance data (e.g., FDA Manufacturer and User Facility Device Experience (MAUDE) 
database), and device labeling for SCS systems.  Please refer to the current Evoke IFUs for the most 
up-to-date risks associated with the Evoke System. 
 

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In addition to the general surgical risks, potential risks to subjects associated with implantation and use 
of the Evoke System include, but are not limited to: 
x 
Undesirable changes in stimulation sensation and/or location  
x 
Uncomfortable changes in stimulation (over and/or under stimulation)  
x 
Persistent post-surgical pain at hardware implantation sites  
x 
CLS migration, which may result in pain or difficulty in charging  
x 
Seroma or hematoma at surgery sites  
x 
Epidural hemorrhage, spinal cord injury and possible paralysis  
x 
Lead migration from the location chosen at initial implantation resulting in stimulation changes  
x 
Breakage of the lead or failure of other system components, which may result in loss of 
stimulation  
x 
Rejection of, or allergic reaction to, the implanted components  
x 
Infection that may require hospitalization with intravenous antibiotic therapy  
x 
Cerebrospinal fluid (CSF) leakage  
x 
Inadequate pain relief following system implantation  
x 
Erosion of the lead or CLS through the skin  
x 
Weakness, clumsiness, numbness or pain  
 
Subjects may require surgery (including revision, explant, and replacement) as a result of any of the 
above.  
12.2  Minimization of Risks 
All known and foreseeable risks associated with the Evoke System have been identified and mitigated 
with appropriate risk controls to reduce the risk as far as possible. 
 
Risks in this study will be minimized by strict compliance with this protocol, and adherence to the 
guidelines for subject selection, site training, and close monitoring of the subject status. In addition, the 
product labeling details instructions for device use, risks, warnings and precautions, which must be 
followed to minimize risk to subjects.  Additionally, only licensed and qualified physicians trained on the 
Evoke System will implant the device, and device programming will be performed by a trained Sponsor 
representative with the oversight of the Investigator.  
12.3  Potential Benefits 
There are several potential benefits of the Evoke System, and specifically with regard to ECAP-
controlled closed-loop stimulation, to participating study subjects suffering from chronic, intractable pain 
of the trunk and/or limbs.  These include:   
x 
The Evoke System may provide insight into the neurophysiological mechanisms of chronic pain 
and SCS. 
x 
The Evoke System may provide significant pain relief. 
x 
The Evoke System may allow patients to reduce their pain medications. 
x 
The Evoke System may improve patients’ quality of life, sleep quality, emotional and/or physical 
functioning. 
x 
The Evoke closed-loop stimulation mode may reduce variation in electrical field strengths 
reaching the spinal cord due to normal physiological activity and movement. 
x 
The Evoke closed-loop stimulation mode may be more effective in providing pain relief 
compared to open-loop stimulation.   
12.4 Benefit-Risk Conclusions 
SCS has been used for over 50 years to aid in the management of chronic, intractable pain of the trunk 
and limbs. The risks associated with participation in this study are outweighed by the potential benefits 
and value of the research. The evidence clearly indicates that although there are risks associated with 
the procedure and the device, the incidence rates are very low, and the majority of complications that 
can result can be treated. In addition, the procedure itself is completely reversible as the device, 

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including the leads, can be removed.  The Evoke System has the added benefit compared to other SCS 
systems in that it can measure spinal cord activation resulting from stimulation and use this measure to 
automatically adjust stimulation current to maintain a target response.  By real-time modulation of the 
output current, the closed-loop system maintains consistent SC activation and thus may maximize the 
therapeutic effect through the corresponding inhibition of pain processing pathways. 
 
13 STUDY ADMINISTRATION 
13.1 Study Materials 
13.1.1 Packaging and Labeling 
In accordance with 21 CFR Part 812, the study device or its immediate package will bear a label with 
the following information: the name and place of business of the manufacturer, packer, or distributor (in 
accordance with 21 CFR Part 801), the quantity of contents, if appropriate, and the following statement: 
“CAUTION—Investigational device. Limited by Federal (or United States) law to investigational use.” 
Labeling describing all relevant contraindications, hazards, adverse effects, interfering substances or 
devices, warnings, and precautions are provided in the IFU. 
13.1.2 Handling and Storage 
The Investigator must ensure that the study devices are controlled and stored according to the IFU.  All 
supplies are to be used only for this study protocol and not for any other purpose. Products are not to 
be used after the expiration date indicated on the label. The Investigator must not destroy any unused 
supply unless instructed by the Sponsor. 
13.1.3 Product Accountability 
The Investigator is responsible for study device accountability, reconciliation, and record maintenance.  
The Investigator must maintain study device accountability records throughout the course of the study. 
13.2 Ethics 
13.2.1 Institutional Review Board Approval 
The protocol, informed consent form (ICF) and authorization for the use and disclosure of health 
information per the Health Insurance Portability Accountability Act (HIPAA) must be approved by the 
investigation site’s Institutional Review Board (IRB) before subject enrollment. Changes to the protocol 
must be approved in writing by the Sponsor and the IRB (as applicable) before the change is 
implemented.  
 
A copy of the IRB approval letter (and approved ICF and subject materials) must be submitted to the 
Sponsor. Investigators are responsible for submitting and obtaining initial approval and continuing 
approval of the study from the IRB and forwarding copies of the approval documentation to the Sponsor.     
13.2.2 Informed Consent 
The Investigator will prepare an ICF in accordance with this study protocol, regulatory requirements (21 
CFR Part 50), Good Clinical Practices (GCP), and the ethical principles that have their origin in the 
Declaration of Helsinki using the sample ICF provided in Appendix A of this study protocol.   
 
As part of the consent process, the subject will have ample time and opportunity to ask questions of, 
and receive answers from the personnel conducting the study, and to decide whether to participate in 
the study. The information that is given to the subject shall be in language understandable to them. 

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Neither the Investigator nor the investigation site personnel shall coerce or unduly influence the subject 
to participate or continue to participate in the study. 
 
All subjects must document their consent for study participation and authorization for use and disclosure 
of health information by signing the IRB-approved ICF. The Investigator will retain the original ICF 
signed by the subject and a copy of the ICF will be provided to the subject. 
 
The Sponsor will inform the Investigator whenever information becomes available that may be relevant 
to the subject’s consent, and will revise the ICF accordingly and provide it to the Investigator for approval 
by the IRB. The Investigator or his/her authorized designee shall inform the subject of this information.  
After approval by the IRB, a copy of this ICF must be provided to the participating subjects, and the 
informed consent process as described above repeated, in accordance with the IRB requirements. 
13.2.3 Subject Confidentiality 
The Sponsor and its designees will make every reasonable effort to protect the confidentiality of the 
subjects participating in the study. Only Sponsor personnel or contracted agents of the Sponsor will 
have access to these confidential files and will act in accordance with applicable regulations as required 
by HIPAA. The IRBs and FDA also have the right to inspect and copy all records pertinent to this study.  
All data used in the reporting of the study will eliminate any identifiable reference to the subjects. 
13.3 Data and Quality Management 
This study will be conducted in accordance with the regulatory requirements, GCP, and the ethical 
principles that have their origin in the Declaration of Helsinki. The study shall not begin until receipt of 
the required approval from the FDA and reviewing IRB. Any additional requirements imposed by the 
FDA or the IRB shall be followed as appropriate. 
13.3.1 Data Collection and Management 
Subject data will be collected and entered in an electronic data capture (EDC) system specifically 
created for this study in accordance with this study protocol, regulatory requirements (21 CFR Part 11), 
and GCP. Data from other external sources (e.g., device logs) may also be entered into the EDC 
system. Data may be reviewed by the Sponsor using programmed or manual queries to ensure 
accuracy of the data entered and minimize the occurrence of missing data. Data management activities 
will be specified in the Data Management Plan. 
13.3.2 Monitoring 
The study will be monitored to ensure the rights and well-being of human subjects are protected; the 
reported study data are accurate, complete, and verifiable from source documents; and the conduct of 
the study is in compliance with the study protocol, regulatory requirements, GCP, Declaration of 
Helsinki, and any conditions of approval imposed by the reviewing IRB and FDA. Monitors will be 
qualified by training and experience to monitor the study in accordance with these requirements.  
Monitoring activities will be conducted in accordance with the Monitoring Plan. 
13.3.3 Audits/Inspections 
Audits of the investigation sites may be performed by the Sponsor or designee, independent of and 
separate from routine monitoring or quality control functions, to evaluate study conduct and compliance 
with the study protocol, applicable regulatory requirements, GCP, Declaration of Helsinki, and any 
conditions of approval imposed by the reviewing IRB and FDA. 
 
The FDA or other regulatory agencies may perform inspections of the investigation sites before, during, 
or after the conclusion of the study. The Investigator shall contact the Sponsor immediately upon 

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notification of inspection, and must fully cooperate with the regulatory agency by permitting inspections 
at reasonable times and in a reasonable manner. 
13.4 Access to Study Records 
The Investigator must permit monitoring and auditing by the Sponsor or designee, and inspection by 
the appropriate regulatory authorities, and provide direct access to all requested study-related records. 
13.5 Investigation Site and Subject Training 
All implanting Investigators will be trained on the device. All primary site personnel (Investigator(s) and 
core site staff) will be trained on the study protocol and the applicable Code of Federal Regulations 
(CFRs).  Support staff may be trained minimally based on delegated tasks.   
13.5.1 Pain Assessment Training 
Despite having validated methods for collecting pain measures, chronic pain clinical studies have been 
plagued by large variability in subjects’ perception of pain and inconsistent reporting of these 
measurements.  For example, a subject may give substantially differing pain scores at different follow-
up time points but describe their pain as not having changed.  For this reason, subject and 
Investigator/investigation site staff training on properly completing pain assessments will be performed 
to provide reliable and useful data.  The training is two-fold, 1) train on the scale being used, and 2) 
train on the pain that is intended to be treated with SCS (to set expectations appropriately).  As 
described by IMMPACT recommendations (26), this protocol requires Investigators (preferably the 
implanting Investigators) to perform a thorough training with the potential subject as part of the baseline 
assessment to set and manage appropriate expectations and increase subject understanding of the 
study indication pain (i.e., pain intended to be treated with SCS), as well as, differentiate comorbid pain 
conditions (non-index/non-study indication pain) to increase the likelihood of conscientious subject 
reporting of pain that is intended to be treated in the study.  To obtain accurate reporting at follow-up, 
re-training will utilize the baseline pain map to remind the subject of the pain identified at baseline in 
which the Investigator intended to treat.  Re-training of subjects on the proper completion of pain 
assessments to provide reliable and useful data may be conducted at any time during the study as the 
Investigator and site staff deem necessary. 
13.6 Investigator Responsibilities 
The Investigator is responsible for ensuring the study is conducted according to the signed Clinical Trial 
Agreement (CTA)/Investigator Agreement (IA), study protocol, regulatory requirements, GCP, 
Declaration of Helsinki, and any conditions of approval imposed by the reviewing IRB and FDA; for 
protecting the rights, safety, and welfare of subjects under the Investigator's care; and for the control of 
devices under investigation.  
13.7 Investigator Agreement and Financial Disclosure 
The Principal Investigator (PI) at each site will be required to sign the Investigator’s Agreement, as per 
21 CFR Part 812. 
 
In addition, in accordance with 21 CFR Part 54, all Investigators will be required to sign a Financial 
Disclosure form, which certifies or discloses the Investigator’s and his/her immediate family’s financial 
interests and arrangements with Saluda Medical.  Investigators must inform the Sponsor of any changes 
to the information within the financial disclosure throughout the course of the study and for a period of 
two years after the device is approved by the FDA or the study is terminated, whichever is later. 

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13.7.1 Investigator Records 
Records to be maintained by the Investigator in the investigation site’s essential study files for this study 
include, but are not limited to: 
x 
Study protocol and all amendments 
x 
Signed IA for the PI 
x 
Signed Financial Disclosure for all Investigators 
x 
IRB approval letter(s) including approved consent and HIPAA authorization form(s), and subject 
materials 
x 
IRB Membership list(s) or Letter of Assurance 
x 
All relevant correspondence relating to the study between the site and Sponsor, the site and 
IRB 
x 
Curriculum Vitae (CV) for all Investigators 
x 
Training documentation 
x 
Delegation of Authority 
x 
Investigational device accountability records including: date, quantity, lot/serial numbers of all 
devices, identification of all persons the device was used on and final disposition.  
 
The following records must be maintained for each subject enrolled in the study: 
x 
Signed ICF and Authorization for the Use and Disclosure of Health Information 
x 
AEs and any supporting documentation 
x 
Protocol deviations 
x 
Source documentation: complete medical records, including procedure reports, professional 
notes, etc. 
13.7.2 Investigator Reports 
Investigators are required to prepare and submit the following complete, accurate, and timely reports: 
 
x 
An Investigator shall submit to the Sponsor and to the reviewing IRB a report of any UADE 
occurring during an investigation as soon as possible, but in no event later than 10 working 
days after the Investigator first learns of the effect.  
 
x 
An Investigator shall report to the Sponsor, within 5 working days, a withdrawal of approval 
by the reviewing IRB of the Investigator's part of an investigation.  
 
x 
An Investigator shall submit progress reports on the investigation to the Sponsor, the monitor, 
and the reviewing IRB at regular intervals, but in no event less often than yearly. 
 
x 
An Investigator shall notify the Sponsor and the reviewing IRB of any deviation from the 
investigational plan to protect the life or physical well-being of a subject in an emergency. 
Such notice shall be given as soon as possible, but in no event later than 5 working days after 
the emergency occurred. Except in such an emergency, prior approval by the Sponsor is 
required for changes in or deviations from a plan, and if these changes or deviations may affect 
the scientific soundness of the plan or the rights, safety, or welfare of human subjects, FDA and 
IRB in accordance with 812.35(a) also is required. 
 
x 
If an Investigator uses a device without obtaining informed consent, the Investigator shall 
report such use to the Sponsor and the reviewing IRB within 5 working days after the use 
occurs.  
 
x 
An Investigator shall, within 3 months after termination or completion of the investigation or the 
Investigator's part of the investigation, submit a final report to the Sponsor and the reviewing 
IRB.  
 
x 
An Investigator shall, upon request by a reviewing IRB or FDA, provide accurate, complete, 
and current information about any aspect of the investigation. 

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13.8 Sponsor Responsibilities 
Saluda Medical Americas, Inc., a fully owned subsidiary of Saluda Medical Pty. Ltd., will serve as 
Sponsor of this clinical investigation and is responsible for selecting qualified Investigators and providing 
them with the information they need to conduct the investigation properly, ensuring proper monitoring 
of the investigation, ensuring that IRB review and approval are obtained, submitting an IDE application 
to FDA, ensuring that any reviewing IRB and FDA are promptly informed of significant new information 
about an investigation, as required in 21 CFR 812 Subpart C, and for Sponsor records and reports 
outlined in 21 CFR Part 812 Subpart G. 
13.8.1 Sponsor Representatives 
Sponsor representatives may participate in the conduct of the trial to the extent described in this 
protocol. Participation in the study will be limited to Sponsor personnel who are appropriately trained. 
Sponsor representatives will operate equipment during the procedures and follow-up, and interact with 
the subject to accomplish procedure and programming activities. Typical tasks may include: 
x 
Interrogating and downloading the device data 
x 
Programming device parameters 
x 
Clarifying device behavior, operation, or diagnostic output  
x 
Assisting with the collection of study data from the device 
x 
Entering data on study worksheets for procedures and programming 
x 
Recording any device deficiencies 
 
The Sponsor representatives may contact the subject at any time to check on their stimulation therapy 
and device functionality.  Based on this interaction, additional training or troubleshooting may be 
provided or the subject may be asked to come into the clinic for reprogramming or troubleshooting.  If 
unsolicited information is reported by the subject that is outside the technical nature of the device, the 
subject will be advised to contact the Investigator.   
 
At no point shall personnel from the Sponsor: 
x 
Practice medicine 
x 
Provide medical diagnosis or treatment to subjects 
x 
Discuss a subject’s medical condition or treatment with a subject without the oversight of a 
healthcare professional 
13.9 Deviations to the Protocol 
An Investigator is required to conduct this study in accordance with the signed CTA/IA, study protocol, 
regulatory requirements, GCP, Declaration of Helsinki, and any conditions of approval imposed by the 
reviewing IRB and FDA.  
 
In accordance with FDA regulation 21 CFR Part 812.150(a)(4), the Investigator shall notify the Sponsor 
and the reviewing IRB of any deviation from the investigational plan to protect the life or physical well-
being of a subject in an emergency. Such notice shall be given as soon as possible, but no later than 
five working days after the emergency occurred.  
 
All deviations from the study protocol must be reported to the Sponsor. Except in an emergency, prior 
approval by the Sponsor is required for an anticipated change in or deviation from the plan and, if these 
changes or deviations could affect the scientific soundness of the plan or the rights, safety or welfare 
of human subjects, prior FDA and IRB approval is also required in accordance with 21 CFR Part 
812.35(a). 
13.10 Amendments to the Protocol 
Any amendments to the study protocol will be clearly documented and approved by the Sponsor and 
the IRB prior to implementation.   
 

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13.11 Completion, Early Termination, or Suspension of the Study 
The Sponsor reserves the right to suspend or terminate the study at an individual investigation site or 
entirely at any time. Suspension or early termination of an investigation site may occur due to serious 
or repeated noncompliance on the part of an Investigator. Reasons for suspension or early termination 
of the entire study may include, but are not limited to, the following: 
x 
The incidence and seriousness of AEs in this or other studies indicates a potential health hazard 
to subjects; 
x 
New information on efficacy from this or other studies; 
x 
The investigational product receives regulatory approval. 
 
Subjects may continue to use the device following study closure, unless notified otherwise by the 
Sponsor (e.g., device does not receive regulatory approval). They will be followed by their physician in 
accordance with established practice for SCS systems. 
13.12 Record Retention 
The Investigator and Sponsor shall maintain the required records during the investigation and for a 
period of two years after the latter of either the completion/termination of the study or the date the Evoke 
System receives regulatory approval for the indication being studied.  An Investigator or Sponsor may 
withdraw from the responsibility to maintain records for the period required and transfer custody of the 
records to any other person who will accept responsibility for them. 
 
The Investigator’s study records may be discarded only upon approval from the Sponsor. The PI must 
contact the Sponsor before destroying any records pertaining to the study to ensure that they no longer 
need to be retained.   
13.13 Clinical Trials Registry/Database (ClinicalTrials.gov) 
This clinical study will be registered on www.ClinicalTrials.gov. Study results will be submitted as 
required. Per the requirements of 21 CFR Part 50, the ICF will contain a statement that clinical trial 
information will be entered into this clinical trials registry/database.     
13.14 Publication 
Publication of clinical data from this trial will be in accordance with the fully executed CTAs.  Publication 
of all data will conform to standards set forth in peer-reviewed journals and the Uniform Requirements 
for Manuscripts Submitted to Biomedical Journals published by the International Committee of Medical 
Journal Editors (ICMJE). 
 
 
 

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ABBREVIATIONS AND ACRONYMS 
Abbreviation/Acronym 
Term 
AE 
Adverse Event 
BPI 
Brief Pain Inventory 
BWS 
Body-Worn System 
CFR 
Code of Federal Regulations 
CL 
Closed-Loop 
CLS 
Closed Loop Stimulator 
CT 
Computed Tomography 
CTA 
Clinical Trial Agreement 
CV 
Curriculum Vitae 
ECAP 
Evoked Compound Action Potential 
EDC 
Electronic Data Capture 
EQ-5D-5L 
EuroQol 5-Dimensional, 5-level quality of life instrument 
ETS 
External Trial System 
FBSS 
Failed Back Surgery Syndrome 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice (For the purposes of this study, this means 
compliance with FDA regulations for IDEs and ISO 14155.) 
HIPAA 
Health Insurance Portability Accountability Act 
IA 
Investigator Agreement 
ICF 
Informed Consent Form 
ICMJE 
International Committee of Medical Journal Editors 
IDD 
Intrathecal Drug Delivery 
IDE 
Investigational Device Exemption 
IFU 
Instructions for Use (e.g., Surgical Guide, User Manual, Clinical Manual, 
Clinical Data Viewer Manual, and supporting materials) 
IMMPACT 
Initiative on Methods, Measurement, and Pain Assessment in Clinical 
Trials 
IPG 
Implantable Pulse Generator 
IRB 
Institutional Review Board 
LTF 
Lost to Follow-up 
MRI 
Magnetic Resonance Imaging 
MCS 
Multi-Channel System 
ODI 
Oswestry Disability Index 
OL 
Open-Loop 
PGIC 
Patient Global Impression of Change 
PI 
Principal Investigator 
POMS 
Profile of Mood States 
PRO 
Patient-Reported Outcome 
PSQI 
Pittsburgh Sleep Quality Index 
SAE 
Serious Adverse Event 
SC 
Spinal Cord 
SCS 
Spinal Cord Stimulator, or Spinal Cord Stimulation 
SF-12 
Short Form Health Survey 
TGA 
Therapeutic Goods Administration 
UADE 
Unanticipated Adverse Device Effect 

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US 
United States 
VAS 
Visual Analog Scale 
 
 

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