NCT04693650

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable chronic-pain

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

February 27, 2023

Status Verified

February 1, 2023

Enrollment Period

11 months

First QC Date

December 31, 2020

Last Update Submit

February 23, 2023

Conditions

Chronic PainLow Back PainLower Limb Pain

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Treatment group- UHF(+RF) stimulation

EXPERIMENTAL

Patients implanted with leads and be administered with UHF stimulation

Device: NeuroBlock UHF stimulation

Control group

NO INTERVENTION

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

Interventions

NeuroBlock UHF stimulationDEVICE

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

Also known as: +RF (plus RF, pulsed RF)
Treatment group- UHF(+RF) stimulation

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

China Medical University Hospital

Taichung, Taiwan

Location

Mackay Memorial Hospital

Taipei, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Veterans General Hospital-Taipei

Taipei, Taiwan

Location

MeSH Terms

Conditions

Chronic PainLow Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBack Pain

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2020

First Posted

January 5, 2021

Study Start

March 1, 2021

Primary Completion

February 1, 2022

Study Completion

April 1, 2022

Last Updated

February 27, 2023

Record last verified: 2023-02

Locations

TW(4)