Noninvasive Brain Stimulation for Treating Carpal Tunnel Syndrome

Part of paid clinical trials in Charlestown, Massachusetts.

Sponsor
Spaulding Rehabilitation Hospital
Study ID
NCT04206215
Status
Recruiting
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Conditions

  • Carpal Tunnel Syndrome
  • Chronic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • transcranial Direct Current Stimulation (tDCS) — DEVICE
    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.
  • Transcranial Ultrasound (TUS) — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Apr 16, 2021
Status verified
Feb 2026
Primary completion
Jul 2, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
95 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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).

Primary Outcome Measure

Visual Analogue Score (VAS) [ Time Frame: 9 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Spaulding Rehabilitation Network Research InstituteCharlestownMassachusetts02129
Felipe Fregni, MD PhD MPH
[email protected]
617-952-6156
Meghan Whalen, BS
[email protected]
617-952-6158
Felipe Fregni, MD PhD MPH (PRINCIPAL_INVESTIGATOR)

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Spaulding Rehabilitation Network Research Institute· Charlestown, MA

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