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

NCT01879787.

Trial name or title Impact of transcranial direct current stimulation (tDCS) on the effects of mental practice and modified constraint‐induced movement therapy (mCIMT) in the rehabilitation of chronic stroke patients
Methods RCT with parallel‐group design
Participants Estimated enrolment: 84
Inclusion criteria: aged between 40 and 80 years; stroke > 6 months prior to enrolment; MMSE ≥ 20; ≤ 3 Ashworth Scale; ≤ 4 Visual Analogue Pain Scale
Exclusion criteria: multiple brain lesions; medication for treatment of spasticity; attention deficit; inability to follow instructions; pregnancy; pacemaker; metal implant in the head; history of convulsion; epilepsy
Interventions 7 arms

  1. A‐tDCS with the anode placed over M1 of the lesioned hemisphere (1 mA for 13 minutes) after 30 minutes of physiotherapy and lastly 45 minutes modified CIMT including 6 hours restraint of the paretic limb at home (mCIMT) 3 times per week for 10 sessions

  2. C‐tDCS with the cathode placed over M1 of the non‐lesioned hemisphere (1 mA for 9 minutes) after 30 minutes of physiotherapy and lastly 45 minutes modified CIMT including 6 hours restraint of the paretic limb at home (mCIMT) 3 times per week for 10 sessions

  3. Dual‐tDCS with the anode placed over M1 of the lesioned hemisphere and the cathode placed over M1 of the non‐lesioned hemisphere (1 mA for 13 minutes) after 30 minutes of physiotherapy and lastly 45 minutes modified CIMT including 6 hours restraint of the paretic limb at home (mCIMT) 3 times per week for 10 sessions

  4. Sham tDCS with the anode placed over M1 of the lesioned hemisphere (1 mA for 30 seconds) after 30 minutes of physiotherapy and lastly 45 minutes modified CIMT including 6 hours restraint of the paretic limb at home (mCIMT) 3 times per week for 10 sessions

  5. tDCS during mental practice after 30 minutes of physiotherapy 3 times per week for 10 sessions

  6. Sham tDCS during mental practice after 30 minutes of physiotherapy 3 times per week for 10 sessions

  7. 30 minutes of physiotherapy 3 times per week for 10 sessions
Outcomes Outcomes will be recorded at baseline and at 1 and 2 months
Primary outcome measures

  1. Change in UE‐FM


Secondary outcome measures

  1. Change in JTT
Starting date January 2011
Contact information Kátia K Monte Silva, PhD
Universidade Federal de Pernambuco
Recife, Pernambuco, Brazil, 50740‐560
Notes