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Behavioural Intervention

Noninvasive Brain Stimulation for Carpal Tunnel Syndrome

N/A
Recruiting
Led By Felipe Fregni, MD PhD MPH
Research Sponsored by Spaulding Rehabilitation Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 weeks
Awards & highlights

Study Summary

This trial is testing if a noninvasive brain stimulation technique can help relieve pain for people with carpal tunnel syndrome.

Who is the study for?
This trial is for adults aged 18-80 with Carpal Tunnel Syndrome causing chronic pain despite previous treatments. Participants must have had pain for at least 6 months, feel it on most days, and rate it at least a 3 out of 10. They can't join if they're pregnant, have used certain medications recently, suffer from major depression or neurological issues like stroke or epilepsy, have metal implants in the brain, or a history of substance abuse.Check my eligibility
What is being tested?
The study tests whether transcranial Direct Current Stimulation (tDCS) combined with Transcranial Ultrasound (TUS) can reduce pain in Carpal Tunnel Syndrome patients better than sham (fake) stimulation. The hypothesis is that active stimulation will lower pain levels more effectively.See study design
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site, mild headaches, tingling sensations during treatment, and fatigue post-treatment. Serious side effects are rare but could involve changes in mood or brain function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old.
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I have chronic wrist pain from CTS, spreading beyond the usual areas, for over 6 months.
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My chronic pain persists despite first-line treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Visual Analogue Score (VAS)
Secondary outcome measures
Boston Carpal Tunnel Questionnaire
Conditioned pain modulation (CPM)
Electroencephalography (EEG)
+16 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active tDCS + Active TUSExperimental Treatment2 Interventions
Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS).
Group II: Sham tDCS + Sham TUSPlacebo Group2 Interventions
Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
transcranial Direct Current Stimulation (tDCS)
2017
Completed Phase 2
~380

Find a Location

Who is running the clinical trial?

Spaulding Rehabilitation HospitalLead Sponsor
133 Previous Clinical Trials
10,928 Total Patients Enrolled
Highland Instruments, Inc.Industry Sponsor
9 Previous Clinical Trials
418 Total Patients Enrolled
Felipe Fregni, MD PhD MPHPrincipal InvestigatorSpaulding Rehabilitation Network
5 Previous Clinical Trials
219 Total Patients Enrolled

Media Library

Transcranial Direct Current Stimulation (tDCS) (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04206215 — N/A
Carpal Tunnel Syndrome Research Study Groups: Active tDCS + Active TUS, Sham tDCS + Sham TUS
Carpal Tunnel Syndrome Clinical Trial 2023: Transcranial Direct Current Stimulation (tDCS) Highlights & Side Effects. Trial Name: NCT04206215 — N/A
Transcranial Direct Current Stimulation (tDCS) (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04206215 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can any eligible individuals still join this research project?

"Affirmative. The clinical trial database portal has indicated that this investigation, which began on April 16th 2021, is still actively recruiting patients. At present, 95 participants must be procured from a single medical centre."

Answered by AI

Is it possible for individuals under the age of thirty-five to be included in this experiment?

"This trial is open to patients aged 18-80. Patients below the age of majority have access to 408 studies and individuals above 65 can choose from 1,351 different options."

Answered by AI

Is it possible to join the research team for this trial?

"This clinical trial is searching for 95 individuals, aged 18 to 80, suffering from chronic pain. Applicants must exhibit extra-median spread of their symptomatic carpal tunnel syndrome across or beyond the median nerve distribution and have reported an average intensity of at least 3 on a 0–10 VAS scale in the previous 6 months. Furthermore, those who apply should be able to experience physical discomfort as self-reported and demonstrate resistance towards first line therapies used to manage long term affliction."

Answered by AI

What is the total cohort size of this scientific experiment?

"Affirmative. Documentation on clinicaltrials.gov indicates that this research initiative, which was initially published on April 16th 2021, is presently recruiting participants. The trial aims to gather data from 95 patients at a single medical facility."

Answered by AI
~14 spots leftby Oct 2024