Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT04206215

Noninvasive Brain Stimulation for Treating Carpal Tunnel Syndrome

Led by Spaulding Rehabilitation Hospital · Updated on 2026-02-20

95

Participants Needed

1

Research Sites

306 weeks

Total Duration

On this page

Sponsors

S

Spaulding Rehabilitation Hospital

Lead Sponsor

H

Highland Instruments, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to assess the effects of tDCS in combination with TUS for the treatment of pain in subjects with Carpal Tunnel Syndrome. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation.

CONDITIONS

Official Title

Noninvasive Brain Stimulation for Treating Carpal Tunnel Syndrome

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to provide informed consent to participate in the study
  • Aged between 18 to 80 years
  • Symptomatic Carpal Tunnel Syndrome with symptoms spreading within or beyond the median nerve area involving at least one wrist
  • Chronic pain lasting at least 6 months, present on at least half the days in the past 6 months, with an average pain score of at least 3 on a 0-10 scale
  • Pain resistant to first line therapies, with pain still present most of the time after treatment
  • Ability to feel pain as self-reported
Not Eligible

You will not qualify if you...

  • Pregnant
  • Contraindications to tDCS and TUS, including intracranial metal implants or implanted brain medical devices
  • History of alcohol or drug abuse within the past 6 months
  • Use of carbamazepine within the past 6 months
  • Major depression with PHQ-9 score of 20 or higher
  • History of neurological disorders such as stroke, brain tumors, or epilepsy with residual symptoms
  • Abnormal EEG activity at baseline
  • History of unexplained fainting spells
  • History of head injury causing more than momentary loss of consciousness with current neurological deficits
  • History of intracranial neurosurgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Spaulding Rehabilitation Network Research Institute

Charlestown, Massachusetts, United States, 02129

Actively Recruiting

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Research Team

F

Felipe Fregni, MD PhD mph

CONTACT

M

Meghan Whalen, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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