NCT03297450.
Trial name or title | tDCS and aphasia therapy in the acute phase after stroke |
Methods | RCT |
Participants | Actual enrolment: 1 Inclusion criteria: diagnosed with mild‒moderate aphasia (Token Test Score between 7 and 40), inclusion in the first few days after stroke (acute phase), age 18 to 85 years, being right‐handed, Dutch as native language, being able to undergo functional and specific linguistic testing and therapy in the acute phase following stroke, imaging (CT or MRI) prior to inclusion (standard of care), signed informed consent Exclusion criteria: history of other diseases of the central nervous system, psychological disorders and (developmental) speech and/or language disorders, serious non‐linguistic cognitive disorders (as documented in the patient's medical history and inquired in anamneses), prior brain surgery, excessive use of alcohol or drugs |
Interventions | 3 arms: ‐ C‐tDCS with 1 mA during the first 20 minutes of aphasia therapy ‐ S‐tDCS during the first 20 minutes of aphasia therapy ‐ S‐tDCS for 20 minutes |
Outcomes | Outcome measures will be recorded at baseline, at 1‐week follow‐up, 3‐month follow‐up, and at 6 months Primary outcome measures: ‐ change in naming performance (BNT) ‐ changing vital parameters (blood pressure and heart rate) Secondary outcome measures: ‐ change in tolerability (visual analogue scale) ‐ change in spontaneous speech (AAT) ‐ change in ERPs |
Starting date | October 2017 |
Contact information | University Hospital Ghent Ghent, East‐Flanders, Belgium, 9000 Prof. Dr .Veerle De Herdt |
Notes | Terminated in August 2018 (difficult patient recruitment) |