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

NCT01539096.

Trial name or title Brain stimulation‐aided stroke rehabilitation: neural mechanisms of recovery
Methods Double‐blind RCT (parallel‐group design)
Participants 30 people 21 years of age and older diagnosed with a stroke that occurred at least 6 months ago
Exclusion criteria: pregnancy, ongoing use of CNS‐activating medications, presence of an electrically, magnetically or mechanically activated implant, including cardiac pacemaker or cochlear implants, metal in the head, history of medication‐resistant epilepsy in the family, history of seizures or unexplained spells of loss of consciousness
Interventions Baseline intervention: CIMT for 3 days a week for 5 weeks for 1 hour each day. Participants will also be asked to use their affected hand in daily activities at home for 5 hours a day while wearing a mitt on the unaffected hand
Experimental: baseline intervention + tDCS to areas of the brain responsible for movement of the affected hand
Sham comparator: baseline intervention + sham tDCS with a similar setup to that for the active tDCS
Outcomes Primary outcome measures: change in upper limb function at baseline during intervention (on average 2.5 weeks from baseline) and at 5 weeks at the end of the intervention period
Secondary outcome measures: study of change in neural mechanisms that underlie the complementary association of cortical stimulation and CIMT
Starting date July 2011
Contact information Ela B Plow, PhD, PT, plowe2@ccf.org
Alexandria Wyant, wyanta@ccf.org
Notes