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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

Primary Purpose

Chronic Pain, Low Back Pain, Lower Limb Pain

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

NeuroBlock UHF stimulation

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 20
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.
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).
Subject is willing and able to comply with the procedure and requirements of this trial.
The subject is able to understand and provide informed consent, and has signed their written informed consent in accordance with IRB requirements.

Exclusion Criteria:

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.
Subject has exhibited unstable pain condition within the past 28 days as interviewed by Investigator.
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.
Subject has unstable pain medication(s) for at least 28 days at investigator's discretion.
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.
Subject has a current diagnosis of cancer with active symptoms.
Subject has a known terminal illness with life expectancy less than one year.
Subject has a systematic or local infection, which may increase study risk.
Subject currently has an indwelling device that may pose an increased risk of infection.
Subject is pregnant or breast feeding.
Subject has a medical history of drug or alcohol addiction within the past 2 years.
Subject has participation in any investigational study in the last 30 days or current enrollment in any trial.
Subject is currently involved in an injury claim law suit or medically related litigation, including workers compensation.
Subject is a prisoner.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment group- UHF(+RF) stimulation

Control group

Arm Description

Patients implanted with leads and be administered with UHF stimulation

Patients implanted with lead receiving fake stimulation (no stimulation but same device procedure with test group)

Outcomes

Primary Outcome Measures

Effectiveness: Responder Rate

The responder rate of the test group and control group at the 2-week visit

Safety: AEs and SAEs

Incidence of adverse events (AEs) and serious AEs (SAEs)

Secondary Outcome Measures

Full Information

NCT ID

NCT04693650

First Posted

December 31, 2020

Last Updated

February 23, 2023

Sponsor

GiMer Medical

1. Study Identification

Unique Protocol Identification Number

NCT04693650

Brief Title

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

Official Title

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

March 1, 2021 (Actual)

Primary Completion Date

February 1, 2022 (Actual)

Study Completion Date

April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GiMer Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pain, Low Back Pain, Lower Limb Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment group- UHF(+RF) stimulation

Arm Type

Experimental

Arm Description

Patients implanted with leads and be administered with UHF stimulation

Arm Title

Control group

Arm Type

No Intervention

Arm Description

Patients implanted with lead receiving fake stimulation (no stimulation but same device procedure with test group)

Intervention Type

Device

Intervention Name(s)

NeuroBlock UHF stimulation

Other Intervention Name(s)

+RF (plus RF, pulsed RF)

Intervention Description

NeuroBlock ultrahigh frequency (UHF) stimulation with 500kHz intra-pulse

Primary Outcome Measure Information:

Title

Effectiveness: Responder Rate

Description

The responder rate of the test group and control group at the 2-week visit

Time Frame

2 weeks

Title

Safety: AEs and SAEs

Description

Incidence of adverse events (AEs) and serious AEs (SAEs)

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 20 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. 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). Subject is willing and able to comply with the procedure and requirements of this trial. The subject is able to understand and provide informed consent, and has signed their written informed consent in accordance with IRB requirements. Exclusion Criteria: Subject has the following conditions by investigator's discretion at screening visit or during the last 3 months: has the mental or psychological condition that affects pain perception or has difficulty performing objective pain assessment or lack of suitability for participation in the study. Subject has exhibited unstable pain condition within the past 28 days as interviewed by Investigator. 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. Subject has unstable pain medication(s) for at least 28 days at investigator's discretion. 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. Subject has a current diagnosis of cancer with active symptoms. Subject has a known terminal illness with life expectancy less than one year. Subject has a systematic or local infection, which may increase study risk. Subject currently has an indwelling device that may pose an increased risk of infection. Subject is pregnant or breast feeding. Subject has a medical history of drug or alcohol addiction within the past 2 years. Subject has participation in any investigational study in the last 30 days or current enrollment in any trial. Subject is currently involved in an injury claim law suit or medically related litigation, including workers compensation. Subject is a prisoner.

Facility Information:

Facility Name

China Medical University Hospital

City

Taichung

Country

Taiwan

Facility Name

Mackay Memorial Hospital

City

Taipei

Country

Taiwan

Facility Name

National Taiwan University Hospital

City

Taipei

Country

Taiwan

Facility Name

Veterans General Hospital-Taipei

City

Taipei

Country

Taiwan

12. IPD Sharing Statement

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