Mononeuritis Multiplex Clinical Trials

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Noninvasive Brain Stimulation for Treating Carpal Tunnel Syndrome

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
United States
Massachusetts
Spaulding Rehabilitation Network Research Institute
RECRUITING
Charlestown
Contact Information
Primary
Felipe Fregni, MD PhD mph
ffregni@partners.org
617-952-6156
Backup
Meghan Whalen, BS
mwhalen7@partners.org
617-952-6158
Time Frame
Start Date: 2021-04-16
Estimated Completion Date: 2027-02-28
Participants
Target number of participants: 95
Treatments
Experimental: Active tDCS + Active TUS
Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS).
Sham_comparator: Sham tDCS + Sham TUS
Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).
Sponsors
Leads: Spaulding Rehabilitation Hospital
Collaborators: Highland Instruments, Inc.

This content was sourced from clinicaltrials.gov