Last updated: December 1, 2023
Sponsor: Soterix Medical
Overall Status: Completed
Phase
2
Condition
Speech Disorders
Communication Disorders
Treatment
HD-tDCS (Soterix Medical, Active)
HD-tDCS (Soterix Medical, Sham)
Clinical Study ID
NCT02540109
SMI092144-P2
1R44NS092144
Ages 25-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- one-time ischemic stroke in the left hemisphere
- greater than 6-months post-stroke onset
- between 25 and 75 years of age
- aphasia diagnosis (as determined by pre-treatment language-based testing)
- right-handed (before the stroke)
- native speaker of English
- ability to provide informed written or verbal consent
Exclusion
Exclusion Criteria:
- clinically reported history of dementia, alcohol abuse, psychiatric disorder,traumatic brain injury, or extensive visual acuity or visual-spatial problems
- factors contraindicative of tDCS administration (sensitive scalp, previous brainsurgery)
- prior history of epileptic or unprovoked seizures occurring during the previous 12months.
- Presence of Metal implants of claustrophobia (not able to undergo MRI)
- Pregnancy
- Presence of any other neurological disease than stroke
- Childhood history of speech, language, hearing, or intellectual impairment
Study Design
Total Participants: 58
Treatment Group(s): 2
Primary Treatment: HD-tDCS (Soterix Medical, Active)
Phase: 2
Study Start date:
July 01, 2015
Estimated Completion Date:
September 30, 2019
Connect with a study center
Georgetown University Medical Center (Peter Turkeltaub, MD, Ph.D.)
Washington, District of Columbia 20057
United StatesSite Not Available
University of North Carolina School of Medicine (Adam Jacks, Ph.D.)
Chapel Hill, North Carolina 27514
United StatesSite Not Available

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