Noninvasive brain stimulation for carpal tunnel syndrome treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of transcranial Direct Current Stimulation (tDCS) combined with Transcranial Ultrasound (TUS) in reducing pain for patients suffering from Carpal Tunnel Syndrome (CTS). The researchers hypothesize that active stimulation will lead to a significant decrease in pain levels compared to sham stimulation. Participants will be monitored for changes in pain intensity over the course of the intervention. The study aims to provide a noninvasive treatment option for chronic pain associated with CTS.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Felipe Fregni, MD PhD MPH — Spaulding Rehabilitation Network
• Study coordinator: Felipe Fregni, MD PhD mph
• Email: ffregni@partners.org
• Phone: 617-952-6156

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.