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 |