NCT01500564.
Trial name or title | Functional Interest of non invasive brain stimulation during physiotherapy at a subacute phase post stroke (anodal protocol) |
Methods | Double‐blind RCT (parallel‐group design) |
Participants | 20 people 18 to 80 years of age; participants volunteer to participate in the study, with written informed consent, affiliation with a national health insurance program, first‐time ever clinical ischaemic or haemorrhagic cerebrovascular accident as evidenced by a radiological (or physician's) report, contralesional motor deficit with a lesion sparing M1, stroke onset > 1 month and < 6 months before study enrolment Exclusion criteria: coexistent major neurological or psychiatric disease, history of epilepsy before stroke, substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing; patients with global aphasia and deficits of comprehension, excessive pain in any joint of the paretic extremity (VAS > 4), contraindications to tDCS such as metal in the head, implanted brain medical devices, history of significant substance abuse in the prior 6 months, antimalarial treatment in the last 72 hours, no prior CIMT/tDCS treatment for stroke; pregnancy |
Interventions | Baseline intervention: 20 minutes of motor training during physiotherapy in 10 consecutive sessions (Monday to Friday) during 2 weeks Experimental: baseline intervention + A‐tDCS over M1 of the ipsilesional hemisphere; stimulation intensity of 1 mA Sham comparator: baseline intervention + sham tDCS over the M1 of the ipsilesional hemisphere |
Outcomes | Primary outcome measures: UE‐FM (change score from baseline to 2 weeks after the end of the intervention period) Secondary outcome measures (change score from baseline to 2 weeks after the end of the intervention period, 2 weeks, 1 month, 3 months and 6 months later): FIM, MAL, JTT, BBT, MAS, muscle strength as measured by MRC |
Starting date | December 2011 |
Contact information | Sophie Jacquin‐Courtois, MD, sophie.courtois@chu‐lyon.fr |
Notes |