NCT00909714.
Trial name or title | Neuroregeneration enhanced by tDCS in stroke |
Methods | Double‐blind RCT (parallel assignment) |
Participants | 250 people aged 18 years and older with subacute stroke (5 to 21 days after stroke), ischaemic subcortical or cortical first‐ever strokes and moderate to moderately severe upper extremity hemiparesis (UE‐FM between 28 and 50) Exclusion criteria: more than 1 stroke; progressive stroke; completely lesioned hand knob area of M1 affected, cerebellar lesions, history of severe alcohol or drug abuse, psychiatric illnesses such as severe depression, poor motivational capacity or severe language disturbances, or with serious cognitive deficits; severe uncontrolled medical problems; rheumatological or traumatic diseases affecting the upper extremities; other neurological diseases; severe microangiopathy, polyneuropathy, ischaemic peripheral disease; pregnancy; contraindication for MRI or TMS |
Interventions | Baseline intervention: standardised upper extremity rehabilitative training; A‐tDCS (20 minutes) or sham tDCS will be applied once a day in combination with standardised upper extremity rehabilitative training Experimental: tDCS once a day for 20 minutes + baseline (polarity and dosage not stated) Control: sham tDCS + baseline |
Outcomes | Primary outcome measures: UE‐FM at 12 months after the end of the intervention period Secondary outcome measures: JTT, ARAT, 9‐HPT, SIS, UE‐FM at days 11, 40, 100 and 190 after the end of intervention period and at 12 months after the end of the intervention period |
Starting date | July 2009 |
Contact information | Friedhelm Hummel, Dr f.hummel@uke.uni‐hamburg.de Christian Gerloff, Prof Dr gerloff@uke.uni‐hamburg.de |
Notes |