RECRUITING

Noninvasive Brain Stimulation for Treating Carpal Tunnel Syndrome

Conditions

Chronic Pain Carpal Tunnel Syndrome transcranial Direct Current Stimulation Transcranial Ultrasound Noninvasive brain stimulation

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Noninvasive Brain Stimulation for Treating Carpal Tunnel Syndrome

Quick Facts

Study Start:2021-04-16

Study Completion:2026-01-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04206215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Study Contact

Felipe Fregni, MD PhD mph

CONTACT

617-952-6156

ffregni@partners.org

Meghan Whalen, BS

CONTACT

617-952-6158

mwhalen7@partners.org

Principal Investigator

Felipe Fregni, MD PhD MPH

PRINCIPAL_INVESTIGATOR

Spaulding Rehabilitation Network

Study Locations (Sites)

Spaulding Rehabilitation Network Research Institute

Charlestown, Massachusetts, 02129

United States

Collaborators and Investigators

Sponsor: Spaulding Rehabilitation Hospital

Felipe Fregni, MD PhD MPH, PRINCIPAL_INVESTIGATOR, Spaulding Rehabilitation Network

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-16

Study Completion Date2026-01-05

Study Record Updates

Study Start Date2021-04-16

Study Completion Date2026-01-05

Terms related to this study

Keywords Provided by Researchers

transcranial Direct Current Stimulation
Transcranial Ultrasound
Noninvasive brain stimulation

Additional Relevant MeSH Terms

Chronic Pain
Carpal Tunnel Syndrome