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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Chronic Pain; Lower Limb Pain
• Intervention / Treatment: Device: NeuroBlock UHF stimulation

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan
    • China Medical University Hospital
  • Taipei, Taiwan
    • Mackay Memorial Hospital
  • Taipei, Taiwan
    • National Taiwan University Hospital
  • Taipei, Taiwan
    • Veterans General Hospital-Taipei

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group- UHF(+RF) stimulation; Patients implanted with leads and be administered with UHF stimulation	Device: NeuroBlock UHF stimulation; NeuroBlock ultrahigh frequency (UHF) stimulation with 500kHz intra-pulse; Other Names: +RF (plus RF, pulsed RF)
No Intervention: Control group; Patients implanted with lead receiving fake stimulation (no stimulation but same device procedure with test group)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: GiMer Medical

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): February 1, 2022
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: December 31, 2020
• First Submitted That Met QC Criteria: December 31, 2020
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Estimate): February 27, 2023
• Last Update Submitted That Met QC Criteria: February 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Chronic Pain
• Other Study ID Numbers: P20002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No