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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

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ClinicalTrials.gov Identifier: NCT04693650
Recruitment Status : Not yet recruiting
First Posted : January 5, 2021
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
GiMer Medical

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Pain Low Back Pain Lower Limb Pain Device: NeuroBlock UHF stimulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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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 Name: +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)


Outcome Measures
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Primary Outcome Measures :
  1. Effectiveness: Responder Rate [ Time Frame: 2 weeks ]
    The responder rate of the test group and control group at the 2-week visit

  2. Safety: AEs and SAEs [ Time Frame: 4 weeks ]
    Incidence of adverse events (AEs) and serious AEs (SAEs)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04693650


Contacts
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Contact: Max Huang +886 2 2697 2680 ext 302 max@gimermed.com
Contact: Tina Chang tina@gimermed.com

Locations
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Taiwan
China Medical University Hospital
Taichung, Taiwan
Contact: Yu-Cheng Liu    +886 975-681575    liuyc1103@hotmail.com   
Principal Investigator: Yu-Cheng Liu         
Mackay Memorial Hospital
Taipei, Taiwan
Contact: Chia-Shiang Lin    +886 975-835522    seancslin@gmail.com   
Principal Investigator: Chia-Shiang Lin         
National Taiwan University Hospital
Taipei, Taiwan
Contact: Chih-Peng Lin    +886 972-651804    cplin0123@gmail.com   
Principal Investigator: Chih-Peng Lin         
Veterans General Hospital-Taipei
Taipei, Taiwan
Contact: Cheng-Chia Lee    +886 938-592570    cclee12@vghtpe.gov.tw   
Principal Investigator: Cheng-Chia Lee         
Sponsors and Collaborators
GiMer Medical
More Information
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Responsible Party: GiMer Medical
ClinicalTrials.gov Identifier: NCT04693650    
Other Study ID Numbers: P20002
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Chronic Pain
Pain
Neurologic Manifestations