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

NCT01983319.

Trial name or title Transcranial direct current stimulation combined with constraint induced movement therapy and role of GABA activity in stroke recovery
Methods RCT with parallel‐group design
Participants Estimated enrolment: 64
Inclusion criteria: age between 18 and 80 years; stroke > 3 months prior to enrolment; > 10° mobility in the wrist, thumb and fingers of the affected side; ability to move, stand up and stand firmly with constraint healthy hand; ability to perform training 6 hours daily in 2 weeks; being able to understand instructions and to co‐operate
Exclusion criteria: contraindication to MRI of the brain; pregnancy; epilepsy, major psychiatric diseases; excessive pain, preventing treatment; history of other diseases resulting in decreased mobility of affected upper limb
Interventions 3 arms
  1. A‐tDCS over upper extremity representation of M1 (1.5 mA for 30 minutes) during CIMT for 10 consecutive daily sessions on workdays

  2. Sham tDCS over upper extremity representation of M1 (dosage not described) during CIMT for 10 consecutive daily sessions on workdays

  3. No Intervention (20 healthy age‐matched control participants will undergo MRI spectroscopy of the brain)

Outcomes Primary outcome measures (measured at baseline and at the end of intervention)
  1. Change in WMFT

  2. Change in UE‐FM


Secondary outcome measures
  1. GABA activity (at baseline)

  2. BBT after single session of tDCS

Starting date September 2013
Contact information Krystian Figlewski, MD
Regionhospital Hammel Neurocenter, Research Unit
Hammel, Denmark, 8450
Notes