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

NCT01414582.

Trial name or title Transcranial direct current stimulation (tDCS) as a potential adjunct intervention in stroke rehabilitation
Methods Double‐blind RCT (parallel assignment)
Participants 80 people 18 to 80 years of age who are willing and able to give informed consent for participation in the study and who should be at least 6 months post first symptomatic stroke affecting motor function of the hand
Exclusion criteria: no adequate understanding of verbal and written information in English, sufficient to complete any of the safety screening forms, previous history of epilepsy, history of drug abuse or a previous history of a neurological or psychiatric illness, or a history of neurosurgical procedure; prescription of medications such as antidepressants, took or taking of antimalarial treatment in the last 72 hours, pregnancy, metallic implant in the neck, head, or eye; any implanted electrical devices, claustrophobia, more than one stroke, limited communication in the form of aphasia or a history of dementia
Interventions Baseline intervention: standardised motor training intervention for the upper paretic limb
Experimental group: baseline Intervention and A‐tDCS over the M1 of the ipsilesional hemisphere, stimulation intensity of 1 mA for the first 20 minutes of motor training (9 consecutive sessions from Monday to Friday)
Sham comparator: baseline Intervention and sham tDCS over M1 of the ipsilesional hemisphere for the first 20 minutes of motor training (9 consecutive sessions from Monday to Friday)
Outcomes Primary outcome measures: UE‐FM, WMFT, ARAT, Nine‐Hole Peg Test
Secondary outcome measures: Reaction Time Test, SIS
All assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately after the end of the intervention period (day 10), 1 week, 1 month and 3 months after the end of the intervention period
Starting date January 2011
Contact information Heidi Johansen‐Berg, Prof, heidi@fmrib.ox.ac.uk
Notes