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. 2016 Mar 21;2016(3):CD009645. doi: 10.1002/14651858.CD009645.pub3

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