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

NCT01897025.

Trial name or title Combined transcranial direct current stimulation and motor imagery‐based robotic arm training for stroke rehabilitation ‐ a feasibility study
Methods RCT with parallel‐group design
Participants Estimated enrolment: 32
Inclusion criteria: first‐ever stroke more than 9 months prior to study enrolment; upper extremity impairment of 11 to 45 on the Fugl‐Meyer assessment scale
Exclusion criteria: epilepsy; neglect; cognitive impairment; other neurological or psychiatric diseases; severe arm pain; spasticity score > 2 MAS in shoulder/elbow joint; contraindications to TMS or tDCS; grip strength < 10 kg as measured by dynamometer; participation in other interventions or trials targeting motor recovery
Interventions 2 arms
  1. A‐tDCS with the anode placed over M1 of the affected hemisphere and the cathode placed over M1 of the unaffected hemisphere (1 mA for 20 minutes) followed by MI‐BCI training with the MIT‐Manus for 40 minutes (10 sessions over 2 weeks)

  2. Sham tDCS with the anode placed over M1 of the affected hemisphere and the cathode placed over M1 of the unaffected hemisphere (1 mA for 30 seconds) followed by MI‐BCI training with the MIT‐Manus for 40 minutes (10 sessions over 2 weeks)

Outcomes Outcomes will be recorded at baseline, at the end of intervention period and 4 weeks after the end of intervention period
Primary outcome measure
  1. UE‐FM


Secondary outcome measures
  1. Resting Motor Threshold of M1 of the affected hemisphere

  2. Grip strength

  3. BBT

  4. MRI parameters

Starting date January 2011
Contact information Effie Chew, MD
National University Hospital
Singapore, Singapore, 119074
Notes