Safety and Efficacy of Carpal Stim in Treating Carpal Tunnel Syndrome

Sponsor
GiMer Medical (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05497037
Collaborator
(none)
88
5
2
9.8
17.6
1.8

Study Details

Study Description

Brief Summary

The objective of this study is to assess the efficacy and safety of Carpal Stim for pain relief in CTS subjects.

Condition or Disease Intervention/Treatment Phase
  • Device: PRF stimulation
  • Device: Sham stimulation
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
88 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Prospective, Multicenter, Randomized, Double-Blind, Two-Arm, Sham-Controlled, Parallel-Design Trial to Assess the Efficacy and Safety of Carpal Stim for Treating Carpal Tunnel Syndrome
Actual Study Start Date :
Mar 9, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Sham Comparator: Sham Control Group

Subject receiving fake stimulation (no stimulation but same device procedure with PRF group)

Device: Sham stimulation
Sham stimulation for 15 min

Active Comparator: PRF Group

Subject receiving 500 KHz PRF stimulation for 15 min

Device: PRF stimulation
One time 500 kHZ stimulation for 15 min

Outcome Measures

Primary Outcome Measures

  1. Effectiveness: The responder rate of the PRF group and Sham-Control group [1 hour after end of stimulation]

  2. Safety: Incidence of adverse events (AEs) and serious AEs (SAEs) [Up to 14 days]

  3. Safety: Change in Nerve Conduction Velocity 14th day compared to baseline [14 days]

    Median nerve sensory latency time change over 20%

Secondary Outcome Measures

  1. Proportion in responder in treatment and sham-controlled groups [3, 7, 14 days after end of stimulation]

  2. Change in NRS score in treatment and sham-controlled groups compared to baseline [1hr, 3, 7, 14 days after end of stimulation]

  3. Change in PGIC scale in treatment and sham-controlled compared to baseline [1hr, 3, 7, 14 days after end of stimulation]

  4. Change in GSS score in treatment and sham-controlled compared to baseline [1hr, 3, 7, 14 days after end of stimulation]

  5. Change in BCTQ-SSS score in treatment and sham-controlled compared to baseline [14 days after end of stimulation]

  6. Change in BCTQ-FSS score in treatment and sham-controlled compared to baseline [14 days after end of stimulation]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Male or female subjects aged ≥ 20 years old during the recruitment phase

  2. Clinical diagnosis of CTS:

  3. Diagnosis of CTS was confirmed by Nerve Conduction Velocity (NCV) but not limited to NCV

  4. Symptoms consistent with CTS for at least 3 months and the numerical rating scale (NRS) score ≥ 5 during the recruitment phase

  5. Willing to abstain from any other treatment or therapy for CTS throughout the trial except protocol-described medications

  6. The subject is willing and able to comply with the procedure and requirements of this trial

  7. The participant is able to understand and provide informed consent, and has signed their written informed consent in accordance with IRB requirements

Exclusion Criteria:
  1. Wrist fractures or cysts at the CTS affected side

  2. Wrist surgery within the past 3 months, especially carpal tunnel release surgery at the CTS affected side

  3. Receiving upper limb (including neck) surgery

  4. Injections of corticosteroids/cortisone into the wrist or hand within the past 3 months

  5. With a past medical history of diabetic polyneuropathy

  6. With a past medical history of rheumatoid arthritis

  7. With a past medical history of epilepsy

  8. Body Mass Index (BMI) > 40 kg/m2

  9. Participation in any investigational study in the last 2 weeks or current enrollment in any trial.

  10. Active infection at the stimulator contact site during the recruitment phase

  11. Pregnant women or diagnosed with postpartum edema in the wrist per investigator's discretion

  12. Patients with implanted medical devices that are electronic products, such as implantable cardioverter defibrillators, pacemakers, spinal cord stimulation systems, or spinal cord drug infusion pumps

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hualien Tzu Chi Hospital Hualien City Taiwan
2 Chung Shan Medical University Hospital Taichung Taiwan
3 National Cheng Kung University Hospital Tainan Taiwan
4 Veterans General Hospital-Taipei Taipei Taiwan
5 Linkou Chang Gung Memorial Hospital Taoyuan Taiwan

Sponsors and Collaborators

  • GiMer Medical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GiMer Medical
ClinicalTrials.gov Identifier:
NCT05497037
Other Study ID Numbers:
  • CTS001
First Posted:
Aug 11, 2022
Last Update Posted:
Aug 16, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 16, 2022