NCT03305614.
| Trial name or title | tDCS and aphasia therapy in the chronic phase after stroke |
| Methods | RCT |
| Participants | Estimated enrolment: 25 Inclusion criteria: diagnosed with mild to moderate aphasia (Token Test Score between 7 and 40) after a first left hemispheric ischaemic or haemorrhagic stroke, inclusion > 6 months post stroke, age 18 to 85 years, being right‐handed (> +8 on the Dutch handedness questionnaire), mother tongue: Dutch, imaging (CT or MRI) prior to inclusion (in patient file), standard of care in the acute phase, 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 patients' medical history and inquired in the anamneses), prior brain surgery, excessive use of alcohol or drugs, new neurological symptoms between the acute stage and inclusion |
| Interventions | 2 arms: ‐ C‐tDCS with 1 mA or S‐tDCS (sic) during the first 20 minutes of aphasia therapy ‐ aphasia therapy |
| Outcomes | Outcome measures will be recorded at baseline, at 3‐week follow‐up, and at 3‐month follow‐up Primary outcome measure: ‐ change in naming performance (BNT) Secondary outcome measures: ‐ change in tolerability (visual analogue scale) ‐ change in spontaneous speech (AAT) ‐ change in ERPs ‐ change in quality of life (Dutch version of the Stroke and Aphasia Quality of Life scale) |
| Starting date | November 2017 |
| Contact information | University Hospital Ghent Ghent, East‐Flanders, Belgium, 9000 Veerle De Herdt, Prof. Dr. Contact: Elien De Cock +32(0)478 21 37 84 evedcock.decock@ugent.be |
| Notes |
AAT: Aachen Aphasia Test ASHA FACS: Functional Assessment of Communication Skills for Adults A‐tDCS: anodal tDCS AQ: aphasia quotient BDAE: Boston Diagnostic Aphasia Examination BNT: Boston Naming Test BOSS: Burden of Stroke Scale C‐tDCS: cathodal tDCS CCRSA: Communication Confidence Rating Scale for Aphasia CETI: Communicative Effectiveness Index CT: computerised tomography EEG: electroencephalography ERP: event‐related potential FDI: first dorsal interosseus FIM: Functional Independence Measure fMRI: functional magnetic resonance imaging GKS: Goodglass‐Kaplan‐Communication‐Scale HD‐tDCS: high definition tDCS Hz: Hertz M1: primary motor cortex mA: milliampere (milliamp) MMSE: Mini Mental State Examination MRI: magnetic resonance imaging NAVS: north‐western assessment and sentences NIHSS: National Institute of Health Stroke Scale NMDA: N‐methyl‐D‐aspartate PNT: Philadelphia Naming Test RCT: randomised controlled trial RMT: resting motor threshold r‐TMS: repetitive transcranial magnetic stimulation S‐tDCS: sham tDCS TBI: traumatic brain injury tDCS: transcranial direct current stimulation WAB: Western Aphasia Battery WAB‐AQ: Western Aphasia Battery ‐ Aphasia Quotient WAB‐R: Western Aphasia Battery – Revised