NCT02901574.
Trial name or title | Cerebellar transcranial direct current stimulation and aphasia treatment |
Methods | Randomised cross‐over trial |
Participants | Estimated enrolment: 50 Inclusion criteria: left hemispheric stroke, fluent speakers of English by self‐report, being capable of giving informed consent or indicating another to provide informed consent, aged above 18, premorbidly right‐handedness, > 6 months post stroke, aphasia diagnosis as confirmed by the BDAE short form, > 65% accuracy screening task (comparable to treatment task) on 1 of 3 attempts Exclusion criteria: participants with lesion involving the right cerebellum, previous neurological or psychiatric disease, seizures during the previous 12 months, uncorrected visual loss or hearing loss by self‐report, use of medications that lower the seizure threshold (e.g. methylphenidate, amphetamine salts), use of NMDA antagonists (e.g. memantine), > 80% (140 out of 175) correct responses on the Philadelphia Naming Test at baseline, history of brain surgery or any metal in the head, scalp sensitivity (per participant report) |
Interventions | Each participant will undergo all of the following conditions: ‐ A‐tDCS or C‐tDCS with 2 mA for 20 minutes plus computerised naming treatment for 15 sessions (45 minutes each) over the course of 3 to 5 weeks ‐ S‐tDCS for 20 minutes plus computerised naming treatment for 15 sessions (45 minutes each) over the course of 3 to 5 weeks |
Outcomes | Outcomes will be recorded at baseline, 2 weeks after the end of intervention period, and at 2 months follow‐up: ‐ Primary outcome measure: ‐ change in accuracy of naming of untrained pictures of the Philadelphia naming test (PNT) from baseline to post intervention Secondary outcome measures: ‐ change in accuracy of naming untrained pictures of the PNT from baseline to 2 weeks after the end of intervention period ‐ change in accuracy of naming untrained pictures of the PNT from baseline to 2 months follow‐up ‐ change in functional communication skills (measured by ASHA FACS) from baseline to post intervention ‐ change in fASHA FACS from baseline to 2 weeks after the end of intervention period ‐ change in ASHA FACS from baseline to 2 months follow‐up ‐ change in lexical features of picture description from baseline to post intervention ‐ change in lexical features of picture description from baseline to 2 weeks after the end of intervention period ‐ change in lexical features of picture description from baseline to 2 months follow‐up |
Starting date | August 2016 |
Contact information | Johns Hopkins University School of Medicine Baltimore, Maryland, USA, 21287 Rajani Sebastian, PhD, 410‐502‐6045, rsebast3@jhmi.edu Donna C Tippett, MA, MPH, 410‐502‐6045, dtippet@jhmi.edu |
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