Noninvasive Brain Stimulation for Treating Carpal Tunnel Syndrome

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Chronic Pain, Carpal Tunnel Syndrome

In brief

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.

Key facts

Study ID

NCT04206215

Run by

Spaulding Rehabilitation Hospital

People needed

95

Starts

2021-04-16

Expected to finish

2027-02-28

Last updated by the study team

2026-02-20

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able to provide informed consent to participate in the study
• Subjects between 18 to 80 years old
• 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).
• Pain resistant to first line therapies of chronic pain (pain still present at lower levels most of the time following therapy)
• Must have the ability to feel pain as self-reported.

You may not qualify if…

• Subject is pregnant
• Contraindications to tDCS+TUS:
• intracranial metal implant
• implanted brain medical devices
• History of alcohol or drug abuse within the past 6 months as self-reported
• Use of carbamazepine within the past 6 months as self-reported
• Suffering from major depression (with a PHQ-9 score of ≥20)
• 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))
• History of unexplained fainting spells as self-reported
• History of head injury resulting in more than a momentary loss of consciousness as self-reported and with current neurological deficits
• History of intracranial neurosurgery as self-reported

Where it is running

• Spaulding Rehabilitation Network Research Institute — Charlestown, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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