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Behavioural Intervention

Noninvasive Brain Stimulation for Carpal Tunnel Syndrome

N/A

Recruiting

Led By Felipe Fregni, MD PhD MPH

Research Sponsored by Spaulding Rehabilitation Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Must not have

Contraindications to tDCS+TUS: intracranial metal implant

Suffering from major depression (with a PHQ-9 score of ≥20)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 weeks

Summary

This trial is testing if a noninvasive brain stimulation technique can help relieve pain for people with carpal tunnel syndrome.

Who is the study for?

This trial is for adults aged 18-80 with Carpal Tunnel Syndrome causing chronic pain despite previous treatments. Participants must have had pain for at least 6 months, feel it on most days, and rate it at least a 3 out of 10. They can't join if they're pregnant, have used certain medications recently, suffer from major depression or neurological issues like stroke or epilepsy, have metal implants in the brain, or a history of substance abuse.

What is being tested?

The study tests whether transcranial Direct Current Stimulation (tDCS) combined with Transcranial Ultrasound (TUS) can reduce pain in Carpal Tunnel Syndrome patients better than sham (fake) stimulation. The hypothesis is that active stimulation will lower pain levels more effectively.

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site, mild headaches, tingling sensations during treatment, and fatigue post-treatment. Serious side effects are rare but could involve changes in mood or brain function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old.

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I have chronic wrist pain from CTS, spreading beyond the usual areas, for over 6 months.

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My chronic pain persists despite first-line treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any metal implants in my head.

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I have severe depression, as shown by my PHQ-9 score.

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I have had brain surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Visual Analogue Score (VAS)

Secondary study objectives

Boston Carpal Tunnel Questionnaire

Conditioned pain modulation (CPM)

Electroencephalography (EEG)

+16 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active tDCS + Active TUSExperimental Treatment2 Interventions

Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS).

Group II: Sham tDCS + Sham TUSPlacebo Group2 Interventions

Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

transcranial Direct Current Stimulation (tDCS)

2017

Completed Phase 2

~420

0 / 6Eligibility criteria met