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

NCT02031107.

Trial name or title Randomized controlled trial of transcranial theta‐burst stimulation and transcranial direct current stimulation in subacute stroke
Methods RCT with parallel‐group design
Participants Estimated enrolment: 45
Inclusion criteria: unilateral stroke with resulting deficits in motor function and significantly impaired activities in daily living at enrolment
Exclusion criteria: epilepsy; metal in the head; implants; pregnancy; sleep deprivation; recent traumatic brain injury; delirium or disturbed vigilance; inability to participate in 1 hour treatment sessions; severe language comprehension deficits; skull breach; recurrent stroke during rehabilitation; medical complications
Interventions 3 arms

  1. C‐tDCS over the motor cortex of the unaffected hemisphere (25 minutes) 3 times per week for 3 weeks during upper extremity sessions

  2. Continuous Theta Burst Stimulation (cTBS) over the motor cortex of the unaffected hemisphere (200 bursts, each consisting of three pulses at 30 Hz, repeated at inter‐burst intervals of 167 ms); 2 stimulation trains of 30 seconds (separated by 15 minutes) will be applied 3 times per week for 3 weeks immediately after physical therapy

  3. half of the participants will receive sham cTBS and half will receive sham tDCS
Outcomes Primary outcome measures

  1. Change in compound motor score slope at week 4 (UE‐FM, 9‐HPT, Jamar dynamometer strength normalised to the healthy arm and averaged to a compound motor score)

  2. Change in alpha‐band coherence between affected motor cortex and the rest of the brain


Secondary outcome measures

  1. Change in UE‐FM at week 4

  2. Change in UE‐FM at week 8

  3. Change in alpha‐band coherence between the unaffected motor cortex and the rest of the brain

  4. Change in MAL at week 4

  5. Change in MAL at week 8

  6. Number of adverse events at week 4

  7. Number of adverse events at week 8

  8. Other outcome measures:

  9. Total UE‐FM at week 4

  10. Total UE‐FM at week 8

  11. Change in average velocity in pegs/sec at week 4

  12. Change in average velocity in pegs/sec at week 8

  13. Change in Jamar dynamometer strength at week 4

  14. Change in Jamar dynamometer strength at week 8

  15. Change in score of the BBT at week 4

  16. Change in score of the BBT at week 8

  17. Correlation between change in alpha‐band coherence and clinical improvements at week 4

  18. Change in fractional anisotropy of the affected corticospinal tract at week 4

  19. Change in correlations of spontaneous fMRI fluctuations within the motor network
Starting date September 2013
Contact information Adrian G Guggisberg, MD
Service de Neurorééducation, Unversity Hospital
Geneva, Switzerland, 1211
Notes