Noninvasive brain stimulation for carpal tunnel syndrome treatment
Noninvasive Brain Stimulation for Treating Carpal Tunnel Syndrome
This study is testing if a new noninvasive brain stimulation treatment can help reduce pain for people with Carpal Tunnel Syndrome.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 95 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Spaulding Rehabilitation Hospital Academic / other |
| Locations | 1 site (Charlestown, Massachusetts) |
| Trial ID | NCT04206215 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of transcranial Direct Current Stimulation (tDCS) combined with Transcranial Ultrasound (TUS) in reducing pain for patients suffering from Carpal Tunnel Syndrome (CTS). The researchers hypothesize that active stimulation will lead to a significant decrease in pain levels compared to sham stimulation. Participants will be monitored for changes in pain intensity over the course of the intervention. The study aims to provide a noninvasive treatment option for chronic pain associated with CTS.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with chronic pain from symptomatic Carpal Tunnel Syndrome that has not responded to first-line therapies.
Not a fit: Patients who are pregnant or have contraindications to tDCS and TUS, such as intracranial metal implants, will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a new noninvasive treatment option for patients with chronic pain from Carpal Tunnel Syndrome.
How similar studies have performed: Other studies have shown promise with noninvasive brain stimulation techniques for pain management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Charlestown, Massachusetts
- Spaulding Rehabilitation Network Research Institute — Charlestown, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Felipe Fregni, MD PhD MPH — Spaulding Rehabilitation Network
- Study coordinator: Felipe Fregni, MD PhD mph
- Email: ffregni@partners.org
- Phone: 617-952-6156
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.