A Prospective, Multi-site, Randomized, Sham-Controlled, Double-Blind Trial With One-Way Crossover Designed to Assess the Effectiveness and Safety of the Gimer NeuroBlock SCS Trialing System for the Treatment of Chronic Back Pain and/or Lower Limb Pain

Not Applicable

Completed

• Conditions: Chronic Pain; Low Back Pain; Lower Limb Pain
• Interventions: Device: NeuroBlock UHF stimulation

• Registration Number: NCT04693650
• Lead Sponsor: GiMer Medical

Brief Summary

This study is a prospective, multi-site, randomized, shamcontrolled, double-blind trial with one-way crossover designed to assess the effectiveness and safety of the Gimer NeuroBlock SCS Trialing System for the treatment of chronic back pain and/or lower limb pain. The NeuroBlock SCS Trialing System is an ultra-high frequency SCS device for the treatment of patients with chronic back pain and/or lower limb pain who are refractory to conservative pain management. After screening procedures, eligible subjects will enter the study which is comprised of a 1-week randomized testing period, a 1-week follow-up period and 2-week observation period.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-31
• Study First Submitted QC: 2020-12-31
• Study First Posted: 2021-01-05
• Study Start: 2021-03-01
• Primary Completion: 2022-02-01
• Study Completion: 2022-04-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-23
• Last Update Posted: 2023-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1. Age ≥ 20
2. Subject has been diagnosed with chronic, intractable pain of the trunk and/or limb(s) and is refractory to conservative therapy for a minimum of six months prior to the screening/baseline visit.
3. Subject has an average pain score of back or leg ≥ 5 or maximum pain score of back or leg ≥ 7 on the Visual Analogue Scale (VAS).
4. Subject is willing and able to comply with the procedure and requirements of this trial.
5. The subject is able to understand and provide informed consent, and has signed their written informed consent in accordance with IRB requirements.

Exclusion Criteria

1. Subject has the following conditions by investigator's discretion at screening visit or during the last 3 months:

   1. has the mental or psychological condition that affects pain perception or
   2. has difficulty performing objective pain assessment or lack of suitability for participation in the study.

2. Subject has exhibited unstable pain condition within the past 28 days as interviewed by Investigator.

3. Subject has a currently diagnosed coagulation disorder, bleeding diathesis, progressive peripheral vascular disease with PLT < 100,000/μl or INR > 1.4 at screening visit.

4. Subject has unstable pain medication(s) for at least 28 days at investigator's discretion.

5. Subject 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.

6. Subject has a current diagnosis of cancer with active symptoms.

7. Subject has a known terminal illness with life expectancy less than one year.

8. Subject has a systematic or local infection, which may increase study risk.

9. Subject currently has an indwelling device that may pose an increased risk of infection.

10. Subject is pregnant or breast feeding.

11. Subject has a medical history of drug or alcohol addiction within the past 2 years.

12. Subject has participation in any investigational study in the last 30 days or current enrollment in any trial.

13. Subject is currently involved in an injury claim law suit or medically related litigation, including workers compensation.

14. Subject is a prisoner.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment group- UHF(+RF) stimulation	NeuroBlock UHF stimulation	Patients implanted with leads and be administered with UHF stimulation

Primary Outcome Measures

Name	Time	Method
Safety: AEs and SAEs	4 weeks	Incidence of adverse events (AEs) and serious AEs (SAEs)
Effectiveness: Responder Rate	2 weeks	The responder rate of the test group and control group at the 2-week visit

Trial Locations

Locations (4)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

Mackay Memorial Hospital; 🇨🇳 Taipei, Taiwan

Veterans General Hospital-Taipei; 🇨🇳 Taipei, Taiwan

China Medical University Hospital; 🇨🇳 Taichung, Taiwan