A Single-arm, Open Label, Single Center Pilot Study to Confirm the Safety of Dorsal Root Ganglia (DRG) and Ultrahigh Frequency Spinal Cord Stimulator in Patients With Chronic Lower Limb Pain
Phase: NA
Conditions: Failed Back Surgery Syndrome, Complex Regional Pain Syndrome (CRPS)
Sponsor: GiMer Medical

  
 
 
 
 
 
 
 
Protocol No.: CTC1601                                  CONFIDENTIAL                   
 
  
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1.     PROTOCOL SYNOPSIS 
Investigational Product 
DRG stimulator (Model 1000) 
Title 
A single-arm, open label, single center pilot study to confirm 
the safety of a dorsal root ganglia (DRG) and high 
frequency stimulator in patients with lower limb pain 
Objectives 
Primary: 
 
To evaluate safety of high frequency DRG 
stimulation by identifying the incidence rate of 
adverse events (AEs) and serious adverse events 
(SAEs) during the trial 
Secondary: 
 
To assess the pain reduction of high frequency 
DRG stimulation  
 
To determine the presence or absence of 
paraesthesia. 
 
To assess the change of pain medication 
consumption 
Indication 
Pain control 
Design 
This study is a prospective, single-arm, open label, single 
center pilot study to confirm the safety of a DRG stimulator in 
patients with lower limb pain 
Population 
Inclusion criteria 
1. Age ≧20 and ≦75 
2. Have a symptom of complex regional pain syndrome 
(CRPS), failed back surgery syndrome (FBSS), lower limb 
radicular/neuropathic pain with or without lower back pain 
with a diagnosis related to spinal lesion and pain history of 
>6 months. 
3. Have an average pain score >5 by Visual Analogue Scale 
(VAS) on inclusion. 
4. Has failed to achieve adequate pain relief from prior 

  
 
 
 
 
 
 
 
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pharmacologic treatments. 
5. In the judgement of the investigator, the subject is an 
appropriate candidate for the trial procedure 
6. The subject is willing and able to comply with the 
procedure and requirements of this trial. 
7. The participant is able to understand and provide informed 
consent, and has signed their written informed consent in 
accordance with IRB requirements. 
Exclusion criteria 
1. Have evidence of a mental or psychological condition that 
affects 
pain 
perception 
and 
has 
difficulty/disability 
performing objective pain assessment, or have previously 
failed mental or psychological assessments administered 
by a psychiatrist that may be deemed to indicate the 
subject’s lack of suitability for participation in this study. 
2. Subject has exhibited escalating or changing pain 
condition within the past 30 days as evidenced by 
Investigator examination. 
3. Be on anticoagulant medication with INR >1.5 or platelet 
count less than 100,000/μL, peripheral vascular diseases 
(PVDs), visceral pain or uncontrolled Diabetes mellitus 
(DM). 
4. Has had corticosteroid therapy at an intended site of 
stimulation within the past 30 days.  
5. Pain medication(s) dosages(s) are not stable for at least 30 
days.  
 6. Has previously failed spinal cord stimulation therapy. 
7. Currently has an active implantable device including ICD, 
pacemaker, spinal cord stimulator or intrathecal drug pump 
or subject requires magnetic resonance imaging (MRIs) or 
diathermy. 
8. Has pain only within a cervical or thoracic distribution. 
9. Have a current diagnosis of cancer with active symptoms. 
10. Have a known terminal illness with life expectancy less 
than one year. 

  
 
 
 
 
 
 
 
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11. Have a systematic or local infection. 
12. Currently has an indwelling device that may pose an 
increased risk of infection. 
13. Be pregnant or breast feeding 
14. Have a medical history of drug or alcohol addiction within 
the past 2 years. 
15. Participation in any investigational study in the last 30 
days or current enrollment in any trial. 
16. Be currently involved in an injury claim law suit or 
medically 
related 
litigation, 
including 
workers 
compensation. 
17. Be a prisoner. 
Sample Size 
10 subjects 
Study Duration 
5 days 
Efficacy Data 
Primary efficacy endpoint: 
 Adverse event (AE) and serious AE (SAE) incidence 
rates during the trial. 
Secondary efficacy endpoints: 
 Change in pain reduction of high frequency DRG 
stimulation (as measured by VAS score compare to 
baseline) 
 Incidence of paresthesia  
 Change in pain medication consumption, including 
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and 
weak opioids, compared to baseline 
Statistical 
Procedures 
All data will be analyzed according to the intention-to-treat 
(ITT) principle. For the intention-to-treat analysis, all recorded 
levels were included, without reference to the subjects’ 
degree of compliance during study period. AE, SAE, and 
paresthesia incidence rates and their 95% confidence interval 
(CI) will be estimated. Repeated measures analysis of 
variance (ANOVA) will be adopted to examine whether there 
are changes in VAS score and pain medication consumption 
during the trial. Last observation carried forward (LOCF) 
approach, specific to longitudinal data problems, will be used 

  
 
 
 
 
 
 
 
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to handle missing data of VAS score and pain medication 
consumption. Due to small number of subjects, no interim 
analysis will be undertaken. The statistical significance level 
will be set at a two-tailed type 1 error of 0.05.