ClinicalTrials.gg
CompletedNCT04693650Updated Feb 27, 2023

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

An interventional study of NeuroBlock UHF stimulation in Chronic Pain, Low Back Pain and Lower Limb Pain, sponsored by GiMer Medical. Completed at 4 sites in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2023-02-27.

Sponsored by GiMer Medical · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 23 studies in Chronic Pain with a site in Taiwan — 3 open to participants now, 4 under way, none of them phase 3. Chronic Pain · Taiwan.

Enrollment
19th of 20
22 · median 67
Started
2021
with 6 others
No phase
14 of 23
3 open now
Registered
9th of 23
by date
Lead sponsor
2 of 23
GiMer Medical

Among the 23 studies in Chronic Pain with a site in Taiwan, this one is the 19th largest by enrollment of the 20 interventional ones that give a count, is one of 7 that started in 2021, is one of 14 with no phase, and was the 9th registered.

Chronic Pain

3,227 studies on the registry are indexed under Chronic Pain; 728 are open to participants now.

Browse Chronic Pain studies →

Open to participants now

3 of the 23 studies in Chronic Pain with a site in Taiwan are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in Taiwan have not opened yet or have stopped. Only those recruiting at a site in Taiwan →

Who these studies take

Of the 486 Chronic Pain studies recruiting now, 239 (49%) set no upper age limit and 173 (36%) stop at 75 or younger; 43 take children under 18; 64 take healthy volunteers.

This study: 20 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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02

Study 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.

03

Conditions studied

  • Chronic Pain
  • Low Back Pain
  • Lower Limb Pain
04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥ 20
  2. Subject has been diagnosed with chronic, intractable pain of the trunk and/or limb(s) and is 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 , and has signed their written informed consent in accordance with IRB requirements.

Exclusion criteria

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 \< 100,000/μl or > 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 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 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.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    Treatment group- UHF(+RF) stimulation

    Patients implanted with leads and be administered with UHF stimulation

    Device: NeuroBlock UHF stimulation

  • No intervention
    Control group

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

Interventions

  • DeviceNeuroBlock UHF stimulation

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

    Also known as: +RF (plus RF, pulsed RF)

06

What researchers measure

Primary outcomes

  1. Effectiveness: Responder Rate

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

    Time frame: 2 weeks

  2. Safety: AEs and SAEs

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

    Time frame: 4 weeks

07

Study locations

4 sites
  • China Medical University Hospital
    Taichung, Taiwan
  • Mackay Memorial Hospital
    Taipei, Taiwan
  • National Taiwan University Hospital
    Taipei, Taiwan
  • Veterans General Hospital-Taipei
    Taipei, Taiwan
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2021 to primary completion in Feb 2022, 11 months.

Of 83 industry-sponsored interventional studies with no phase under Chronic Pain, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 30. This study's 11 months is below that.

Counting every sponsor, half of 1,378 studies reached it within 20 months; a quarter within 9 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 31, 2020
First posted
Jan 5, 2021
StartActual
Mar 1, 2021
Primary completionActual
Feb 1, 2022
CompletionActual
Apr 1, 2022
Last update
Feb 27, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04693650
Lead sponsor
GiMer Medical
Responsible party
Sponsor
First posted
Jan 5, 2021
Start date
Mar 1, 2021
Primary completion
Feb 1, 2022
Completion
Apr 1, 2022
Last update
Feb 27, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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