Noninvasive Brain Stimulation for Treating Carpal Tunnel Syndrome

NCT ID
NCT04206215
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
Spaulding Rehabilitation Hospital
Conditions
Carpal Tunnel Syndrome, Chronic Pain

Overview

ClinicalTrials.gov lists this study as Recruiting.

Enrollment: 95 participants (Estimated).

What is being studied

  • Intervention: Behavioral Disciplines and Activities
  • Intervention: Convulsive Therapy
  • Intervention: Electric Stimulation Therapy
  • Intervention: Electroshock
  • Intervention: Psychiatric Somatic Therapies
  • Intervention: Psychological Techniques
  • Intervention: Therapeutics
  • Intervention: Transcranial Direct Current Stimulation
  • Device: transcranial Direct Current Stimulation (tDCS)
  • Device: Transcranial Ultrasound (TUS)

Who may be eligible

Ages
18 Years to 80 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: 1. Able to provide informed consent to participate in the study 2. Subjects between 18 to 80 years old 3. Having symptomatic CTS spreading within or beyond the median nerve distribution (demonstrating 'extra-median spread'), involving at least 1 wrist, with chronic pain as defined by International Association for the Study of Pain (existing pain for at least 6 months and having pain on at least half the days in the past 6 months with an average of at least a 3 on a 0-10 VAS scale). 4. Pain resistant to first line therapies of chronic pain (pain still present at lower levels most of the time following therapy) 5. Must have the ability to feel pain as self-reported. Exclusion Criteria: 1. Subject is pregnant 2. Contraindications to tDCS+TUS: 1. intracranial metal implant 2. implanted brain medical devices 3. History of alcohol or drug abuse within the past 6 months as self-reported 4. Use of carbamazepine within the past 6 months as self-reported 5. Suffering from major depression (with a PHQ-9 score of ≥20) 6. History of neurological disorders involving stroke, brain tumors, or epilepsy with residual neurological symptoms as self-reported (note patients will also be evaluated via EEG at baseline about 1 week prior to stimulation and any patient showing abnormal EEG activity will be removed)) 7. History of unexplained fainting spells as self-reported 8. History of head injury resulting in more than a momentary loss of consciousness as self-reported and with current neurological deficits 9. History of intracranial neurosurgery as self-reported

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

  • Massachusetts, United States: 1

Sample of listed locations

  • Spaulding Rehabilitation Network Research Institute — Charlestown, Massachusetts, 02129, United States — Recruiting

Study details

Start date
April 16, 2021
Primary completion date
July 2, 2027
Completion date
December 28, 2027
First posted
December 20, 2019
Collaborators
Highland Instruments, Inc.

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT04206215
Registry last updated
August 18, 2026
QualifiedStudies registry data refreshed
October 2, 2026
QualifiedStudies record fetched
October 2, 2026

View NCT04206215 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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