NCT02540109.
Trial name or title | Targeted Electrotherapy for Aphasia Stroke Rehabilitation (TEASER) ‐ phase II multi‐centre study |
Methods | RCT |
Participants | Estimated enrolment: 58 Inclusion criteria: 1‐time ischaemic stroke in the left hemisphere, > 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 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 brain surgery), prior history of epileptic or unprovoked seizures occurring during the previous 12 months, presence of metal implants or claustrophobia (not able to undergo MRI), pregnancy, presence of any other neurological disease than stroke, childhood history of speech, language, hearing, or intellectual impairment |
Interventions | 2 arms (prior to treatment MRI and fMRI are acquired to inform the individualised current flow models for optimal targeting): ‐ HD‐tDCS in individualised dosage (number of electrodes and electrode placement) ‐ S‐tDCS in individualised dosage (number of electrodes and electrode placement) |
Outcomes | Primary outcome measure: ‐ the ability of participants to name objects in a standardised naming task Secondary outcome measures: ‐ naming performance at 4 weeks and 6 months after treatment ‐ improvements in more general discourse performance ‐ screening comparison of HD‐tDCS with historical data on conventional non‐targeted tDCS using sponge electrodes |
Starting date | July 2015 |
Contact information | Abhishek Datta, PhD 888‐990‐8327 contact@soterixmedical.com |
Notes |