A Single-arm, Open Label, Single Center, Prospective Study of Ultra-high Frequency (500 KHz) Spinal Cord Stimulation for Treatment of Chronic Back Pain or Lower Limb Pain
Phase: NA
Conditions: Pain, Chronic, Pain, Back, Pain, Radiating
Sponsor: GiMer Medical

  
 
 
 
 
 
Protocol No.: PT1710001                             CONFIDENTIAL                          
  
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1. 
PROTOCOL SYNOPSIS 
Investigational Product 
SCS trial stimulator (Model 1000) 
Title 
A single-arm, open label, single center, prospective study of 
an ultra-high frequency spinal cord stimulation for treatment 
of chronic back pain or lower limb pain 
Objectives 
Primary: 
 To assess the analgesic effectiveness of ultra-high 
frequency spinal cord stimulation (as measured by 
VAS score compared to baseline) 
 To evaluate safety of ultra-high frequency spinal cord 
stimulation by identifying the incidence rate of adverse 
events (AEs) and serious adverse events (SAEs) 
during the trial 
Secondary: 
 The change from baseline in functionality using the 
BPI/ODI evaluations 
 To determine the presence or absence of stimulation-
induced paresthesia. 
 To assess the change of pain medication consumption 
Indication 
Pain control 
Design 
This study is a prospective, single-arm, open label, single 
center to confirm the effectiveness and safety of an ultra-high 
frequency spinal cord stimulation in patients with chronic back 
pain or lower limb pain. 
Population 
Inclusion criteria 
1. Age ≧20 and ≦75 
2. Have a symptom of back or lower limb pain with a 
diagnosis related to spinal lesion, herniatic disc, nerve 
injury, stenosis, failed back surgery syndrome (FBSS), 
complex regional pain syndrome (CRPS) or ischemic 
lower limb pain and have pain history of >6 months. 
3. Have an average pain score >5 by Visual Analogue Scale 

  
 
 
 
 
 
Protocol No.: PT1710001                             CONFIDENTIAL                          
  
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(VAS) on inclusion. 
4. Has failed to achieve adequate pain relief from prior 
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 unstable pain condition within the 
past 30 days as interviewed by Investigator. 
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 at investigator’s discretion. 
6. 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. 
7. Have a current diagnosis of cancer with active symptoms. 
8. Have a known terminal illness with life expectancy less 
than one year. 
9. Have a systematic or local infection, which may increase 
study risk. 

  
 
 
 
 
 
Protocol No.: PT1710001                             CONFIDENTIAL                          
  
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10. Currently has an indwelling device that may pose an 
increased risk of infection. 
11. Be pregnant or breast feeding. 
12. Have a medical history of drug or alcohol addiction within 
the past 2 years. 
13. Participation in any investigational study in the last 30 
days or current enrollment in any trial. 
14. Be currently involved in an injury claim law suit or 
medically 
related 
litigation, 
including 
workers 
compensation. 
15. Be a prisoner. 
Sample Size 
10 evaluated subjects 
Study Duration 
14 (+1) days 
Efficacy Data 
Primary endpoint: 
 Analgesic effectiveness of ultra-high frequency spinal 
cord stimulation (as measured by VAS score compare 
to baseline) 
 Adverse event (AE) and serious AE (SAE) incidence 
rates during the trial 
Secondary endpoints: 
 Change in BPI/ODI compared to baseline 
 Incidence of stimulation-induced 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 full analysis set 
principle, including patients who received at least one dose of 
study treatment and had at least one follow-up evaluation 
regardless of their compliance with the protocol. Repeated 
measures analysis of variance (ANOVA) will be adopted to 
examine whether there are changes in VAS/BPI/ODI scores 
and pain medication consumption during the trail. The 
frequent endpoints in this study include AE, SAE and 
incidence of paresthesia of stimulation-induced. The 
incidence rates and their 95% confidence interval (CI) will be 
estimated. A Last Observation Carried Forward (LOCF) 

  
 
 
 
 
 
Protocol No.: PT1710001                             CONFIDENTIAL                          
  
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method will be used to define endpoints if data is unavailable 
at the analysis time point; the last available measurement 
prior to the visit will be used to fill in the missing data. Interim 
analysis with Pocock-type group sequential plan will be 
undertaken for the likelihood of no merging trends and no 
reasonable chance of demonstrating benefit after 5 subjects 
are enrolled. The statistical significant level will be set at a 
two-tailed type 1 error of 0.05.