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NCT04206215NARecruiting

Noninvasive Brain Stimulation for Treating Carpal Tunnel Syndrome

Spaulding Rehabilitation Hospital

Start Date

4/16/2021

Completion Date

2/28/2027

Summary

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.

Eligibility Criteria

Age Range: 18 years to 80 years

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

Interventions

DEVICE

transcranial Direct Current Stimulation (tDCS)

DEVICE

Transcranial Ultrasound (TUS)

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Conditions

Chronic PainCarpal Tunnel Syndrome

Locations

Spaulding Rehabilitation Network Research Institute

Charlestown, Massachusetts 02129

United States