NCT04206215 Noninvasive Brain Stimulation for Treating Carpal Tunnel Syndrome
| NCT ID | NCT04206215 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Spaulding Rehabilitation Hospital |
| Condition | Chronic Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 95 participants |
| Start Date | 2021-04-16 |
| Primary Completion | 2027-07-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 95 participants in total. It began in 2021-04-16 with a primary completion date of 2027-07-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Felipe Fregni, MD PhD MPH
PRINCIPAL INVESTIGATOR
Spaulding Rehabilitation Network
Frequently Asked Questions
Who can join the NCT04206215 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Chronic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04206215 currently recruiting?
Yes, NCT04206215 is actively recruiting participants. Contact the research team at ffregni@partners.org for enrollment information.
Where is the NCT04206215 trial being conducted?
This trial is being conducted at Charlestown, United States.
Who is sponsoring the NCT04206215 clinical trial?
NCT04206215 is sponsored by Spaulding Rehabilitation Hospital. The principal investigator is Felipe Fregni, MD PhD MPH at Spaulding Rehabilitation Network. The trial plans to enroll 95 participants.
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