Safety and Efficacy of Carpal Stim in Treating Carpal Tunnel Syndrome

NCT05497037 | Completed

• 1 other identifier: CTS001
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (3)

• Effectiveness: The responder rate of the PRF group and Sham-Control group

  1 hour after end of stimulation

• Safety: Incidence of adverse events (AEs) and serious AEs (SAEs)

  Up to 14 days

• Safety: Change in Nerve Conduction Velocity 14th day compared to baseline

  Median nerve sensory latency time change over 20%

  14 days

Secondary Outcomes (6)

• Proportion in responder in treatment and sham-controlled groups

  3, 7, 14 days after end of stimulation

• Change in NRS score in treatment and sham-controlled groups compared to baseline

  1hr, 3, 7, 14 days after end of stimulation

• Change in PGIC scale in treatment and sham-controlled compared to baseline

  1hr, 3, 7, 14 days after end of stimulation

• Change in GSS score in treatment and sham-controlled compared to baseline

  1hr, 3, 7, 14 days after end of stimulation

• Change in BCTQ-SSS score in treatment and sham-controlled compared to baseline

  14 days after end of stimulation

Study Arms (2)

Sham Control Group

SHAM COMPARATOR

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

Device: Sham stimulation

PRF Group

ACTIVE COMPARATOR

Subject receiving 500 KHz PRF stimulation for 15 min

Device: PRF stimulation

Interventions

PRF stimulation DEVICE

One time 500 kHZ stimulation for 15 min

PRF Group

Sham stimulation DEVICE

Sham stimulation for 15 min

Sham Control Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged ≥ 20 years old during the recruitment phase
• Clinical diagnosis of CTS：
• Diagnosis of CTS was confirmed by Nerve Conduction Velocity (NCV) but not limited to NCV
• Symptoms consistent with CTS for at least 3 months and the numerical rating scale (NRS) score ≥ 5 during the recruitment phase
• Willing to abstain from any other treatment or therapy for CTS throughout the trial except protocol-described medications
• The subject is willing and able to comply with the procedure and requirements of this trial
• The participant 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:

• Wrist fractures or cysts at the CTS affected side
• Wrist surgery within the past 3 months, especially carpal tunnel release surgery at the CTS affected side
• Receiving upper limb (including neck) surgery
• Injections of corticosteroids/cortisone into the wrist or hand within the past 3 months
• With a past medical history of diabetic polyneuropathy
• With a past medical history of rheumatoid arthritis
• With a past medical history of epilepsy
• Body Mass Index (BMI) \> 40 kg/m2
• Participation in any investigational study in the last 2 weeks or current enrollment in any trial.
• Active infection at the stimulator contact site during the recruitment phase
• Pregnant women or diagnosed with postpartum edema in the wrist per investigator's discretion
• 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

Sponsors & Collaborators

• GiMer Medical: lead

Study Sites (5)

Hualien Tzu Chi Hospital

Hualien City, Taiwan

Location

Chung Shan Medical University Hospital

Taichung, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

Veterans General Hospital-Taipei

Taipei, Taiwan

Location

Linkou Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Design

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

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 11, 2022
• Study Start: March 9, 2022
• Primary Completion: December 31, 2022
• Study Completion: February 8, 2023
• Last Updated: February 27, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (5)