Abstract Details

Title Efficacy and Safety of Coupled and Uncoupled Transcranial Brain Stimulations in Ischemic Stroke: A Randomised Clinical Trial

Topic Neuro-rehabilitation

Presentation(s) N5 - Neuroscience in the Clinic: Neuromodulation Tools in Stroke Acute Treatment, Prevention, and Recovery (2:00 PM-2:15 PM)

Poster/Presentation
Number 003

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.

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.

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.

Authors/Disclosures
Sunil K. Narayan, MD, FAAN (Jawaharlal Institute of Postgraduate Medl Edu and Research) PRESENTER	The institution of Dr. Narayan has received research support from Indian Council of Medical Research, Ministry of Health and Family Welfare, Government of India. The institution of Dr. Narayan has received research support from Department of Biotechnlogy, Ministry of Science and Technology, Government of India. The institution of Dr. Narayan has received research support from DST-(SERB). The institution of Dr. Narayan has received research support from Ms.Gurutva Medical Technology, India. Dr. Narayan has received intellectual property interests from a discovery or technology relating to health care. Dr. Narayan has received intellectual property interests from a discovery or technology relating to health care. Dr. Narayan has received personal compensation in the range of $0-$499 for serving as a Intermediate Grants, Evaluation Expert committee Member with Department of Health Research, Government of India.
Jeshma Jayan, PT	Miss Jayan has nothing to disclose.
Bhanumathy Mohanakrishnan, PT	Mrs. Mohanakrishnan has nothing to disclose.

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