Objective:

To compare the efficacy and safety of decoupled (rTMS or tDCS) or coupled non-invasive  brain stimulation (NIBS)  with sham stimulation as comparator, for motor recovery  in ischemic stroke.    

Background:

Effects of non-invasive brain stimulation (NIBS) techniques, on stroke rehabilitation remain inconclusive because of quality issues of studies.  Meta-analyses also fail to provide robust answers  because of heterogeneity between studies. 2018 and the 2023 updates of  IFCN guidelines provide for more robust and pragmatic NIBS trials. 

Design/Methods:

Investigator-initiated, university-funded, double-blind, RCT following IFCN 2021 guidelines with 4 parallel groups (Computer-generated block randomisation): Real Ipsilateral Anodal tDCS followed by contralateral 1 Hz rTMS (23), Sham tDCS and Real rTMS (28), Sham rTMS and real tDCS (28) and Sham tDCS and Sham rTMS (21) X 10 days, recruiting 18-70 yrs-old, first-ever MCA ischemic stroke, 3-6 months post-stroke, normal MOCA, Brunnstorm  3-5.  Allocation concealment using sealed envelopes. MCF-B70 butterfly coils, MagPro R100 (MagVenture TMS Therapy®13) for rTMS and HD-tDCS. Primary outcome  parameter: Fugel-Mayer Assessment at 3 months. Secondary: Day-11 modified modified Ashworth Scale & Somatosensory evoked potentials amplitude; 3-months MMAS, mRS and SSQoL and adverse events. Post-stimulation change in FMA and other outcome measures between treatment groups and post and prestimulation  measures for predefined outcomes analysed using SPSS v22.

Results:

There were no significant adverse events. The change in primary outcome, 3-months FMA was significantly higher (P<0.001) in rTMS group . On paired Wilcoxon-Rank test, significant improvement was seen for  FMA with TMS, MMAS with tDCS and mRS and SEP amplitude for all real NIBS groups.  The over all ANCOVA and RMANOVA for repeated measure comparisons did not show significant differences between the groups. 

Conclusions:

NIBS interventions in 3-6 months post-ischemic stroke is feasible and safe. NIBS potocols differentially induced sustainable improvements in hand  motor function, spasticity and SEP amplitude. Larger multicentre trials following similar protocols may consolidate these results.