Noninvasive Brain Stimulation for Treating Carpal Tunnel Syndrome

Mass General Brigham

Status: Enrolling

Conditions: Carpal Tunnel Syndrome; Chronic Pain

Treatments: Device: transcranial Direct Current Stimulation (tDCS); Device: Transcranial Ultrasound (TUS)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04206215

2019P002804

Details and patient eligibility

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.

Enrollment: 95 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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95 participants in 2 patient groups

Active tDCS + Active TUS

Experimental group

Description:

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

Treatment:

Device: Transcranial Ultrasound (TUS)

Device: transcranial Direct Current Stimulation (tDCS)

Sham tDCS + Sham TUS

Sham Comparator group

Description:

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

Treatment:

Device: Transcranial Ultrasound (TUS)

Device: transcranial Direct Current Stimulation (tDCS)