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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion 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.

Exclusion Criteria

  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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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).
  • Device: transcranial Direct Current Stimulation (tDCS)
    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.
  • Device: Transcranial Ultrasound (TUS)
    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.
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).
  • Device: transcranial Direct Current Stimulation (tDCS)
    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.
  • Device: Transcranial Ultrasound (TUS)
    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.

Recruiting Locations

Spaulding Rehabilitation Network Research Institute
Charlestown, Massachusetts 02129
Contact:
Felipe Fregni, MD PhD MPH
617-952-6156
ffregni@partners.org

More Details

Status
Recruiting
Sponsor
Spaulding Rehabilitation Hospital

Study Contact

Felipe Fregni, MD PhD mph
617-952-6156
ffregni@partners.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.