Recruiting

Noninvasive Brain Stimulation

Sponsor:

Spaulding Rehabilitation Hospital

Code:

NCT04206215

Conditions

Chronic Pain

Carpal Tunnel Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

transcranial Direct Current Stimulation (tDCS)

Transcranial Ultrasound (TUS)

Study Details

Brief 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.

Conditions

Chronic Pain

Carpal Tunnel Syndrome

Study ID

NCT04206215

Start date

Apr 16, 2021

Status verified date

Aug, 2026

Completion date

Dec 28, 2027

Anticipated

Primary completion date

Jul 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

95 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active tDCS + Active TUS

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

sham comparator: Sham tDCS + Sham TUS

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

Interventions

transcranial Direct Current Stimulation (tDCS)

Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2mA. In the sham group, the tDCS device will not be active for the full 20 minutes.

Transcranial Ultrasound (TUS)

Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.

Primary outcome measure

  • Visual Analogue Score (VAS) [ Time Frame: 9 weeks ]

Central Contacts and Locations

Central contacts

Locations

Spaulding Rehabilitation Network Research Institute

Recruiting

Charlestown, Massachusetts, United States, 02129

Contacts

Principal Investigator:

Felipe Fregni, MD PhD MPH

More Information

Sponsor

Spaulding Rehabilitation Hospital

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Keywords

  • transcranial Direct Current Stimulation
  • Transcranial Ultrasound
  • Noninvasive brain stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Spaulding Rehabilitation Hospital on 2026-08-18.