NCT04206215 · Spaulding Rehabilitation Hospital
Noninvasive Brain Stimulation for Treating Carpal Tunnel Syndrome
What this study is 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.
View original scientific description
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.
Interventions
DEVICE
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.
DEVICE
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 measures
Visual Analogue Score (VAS)
Time frame: 9 weeks
Changes in the Visual Analogue Scale (VAS) for pain will be measured in order to determine whether anodal transcranial direct current stimulation in conjunction with transcranial ultrasound is effective in reducing pain in subjects with Carpal Tunnel Syndrome. The VAS scale goes from 0 up to 10, where 0 means no pain at all and 10 means the worst imaginable pain.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Able to provide informed consent to participate in the study
- 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).
- Pain resistant to first line therapies of chronic pain (pain still present at lower levels most of the time following therapy)
- Must have the ability to feel pain as self-reported.
Exclusion criteria
- Subject is pregnant
- Contraindications to tDCS+TUS:
- intracranial metal implant
- implanted brain medical devices
- History of alcohol or drug abuse within the past 6 months as self-reported
- Use of carbamazepine within the past 6 months as self-reported
- Suffering from major depression (with a PHQ-9 score of ≥20)
- 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))
- History of unexplained fainting spells as self-reported
- History of head injury resulting in more than a momentary loss of consciousness as self-reported and with current neurological deficits
- History of intracranial neurosurgery as self-reported
Where
- Charlestown, Massachusetts
Collaborators
Highland Instruments, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 20, 2026 · Source of record for eligibility and locations