ACTRN12613000109707.
Trial name or title | A pilot investigation of the effect of cathodal transcranial direct current stimulation (ctDCS) plus standard upper limb rehabilitation to augment motor recovery post acute stroke |
Methods | RCT with blinded outcome assessor ITT analysis: yes |
Participants | 37 to 40 people between 18 and 80 years of age with acute first‐ever ischaemic stroke (in the first week) and moderate to severe hemiparesis (UE‐FM ≤ 52) with MEPs detectable by TMS, stable blood pressure parameters and MMSE > 24 Exclusion criteria: pre‐existing upper limb impairment causing functional limitation, hemiplegic shoulder pain, metallic implants (pacemaker or artificial cochlea), history of seizure or another unstable medical condition, pregnancy, severe language disturbance, English as a second language, severe neglect (score < 44 out of 54 points on the Star Cancellation test), history of depression, alcohol or drug abuse, coexistent neurological or psychiatric disease, current treatment with antidepressants, antipsychotics or benzodiazepines or current treatment with Na+ or Ca2+ Channel blockers or NMDA receptor antagonists |
Interventions | 10 rehabilitation sessions (30 minutes each) to the affected arm over a period of 2 weeks (i.e. 5 days of treatment, 2 days rest, 5 days of treatment) + 1 of the following interventions:
|
Outcomes | All assessments are to be completed at baseline and at 1 day, 2 weeks and 3 months after the end of the intervention Primary outcome measure: UE‐FM change scores Secondary outcome measures: MEP as measured by TMS, NIHSS, Tardieu Spasticity Assessment, FIM, PostStroke Depression Scale |
Starting date | 4 February 2013 |
Contact information | Ms Jimena Garcia‐Vega, jimena.garcia‐vega@health.wa.gov.au |
Notes |