Noninvasive Brain Stimulation for Treating Carpal Tunnel Syndrome
1 other identifier
interventional
95
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable chronic-pain
Started Apr 2021
Longer than P75 for not_applicable chronic-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2019
CompletedFirst Posted
Study publicly available on registry
December 20, 2019
CompletedStudy Start
First participant enrolled
April 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 2, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2027
February 20, 2026
February 1, 2026
5.2 years
December 2, 2019
February 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual Analogue Score (VAS)
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.
9 weeks
Secondary Outcomes (19)
Verbal Rating Scale (VRS)
Measured for approximately for a total 9 weeks
Visual Analog Mood Scale (VAMS)
Measured for approximately for a total 9 weeks
Montreal Cognitive Assessment (MOCA)
Measured for approximately for a total 9 weeks
tDCS Side Effects Questionnaire
Measured for approximately for a total 9 weeks
Patient Health Questionnaire (PHQ-9)
Measured for approximately for a total 9 weeks
- +14 more secondary outcomes
Study Arms (2)
Active tDCS + Active TUS
EXPERIMENTALSubjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS).
Sham tDCS + Sham TUS
SHAM COMPARATORSubjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Spaulding Rehabilitation Hospitallead
- Highland Instruments, Inc.collaborator
Study Sites (1)
Spaulding Rehabilitation Network Research Institute
Charlestown, Massachusetts, 02129, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Felipe Fregni, MD PhD MPH
Spaulding Rehabilitation Network
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 2, 2019
First Posted
December 20, 2019
Study Start
April 16, 2021
Primary Completion (Estimated)
July 2, 2026
Study Completion (Estimated)
February 28, 2027
Last Updated
February 20, 2026
Record last verified: 2026-02