Abstract Background and aims The Canadian Platform for Trials in Non-Invasive Brain Stimulation (CanStim) developed a standardized consensus protocol for rTMS (repetitive Transcranial Magnetic Stimulation) as an adjunct to standardized therapy for upper limb rehabilitation in sub-acute stroke Edwards, NNR 2021 35(2). Here we report results of ConTRAstroke, a clinical feasibility trial testing the CanStim protocol in a multi-center setting at 8 sites. Methods 83 patients with first ischemic stroke were consented. 77 patients (age 64.0±13.0 years, NIHSS 4.2±2.5, 43% female) were randomized (mean 44.6 days ±20.3). Inclusion criteria were Fugl-Meyer Upper Extremity (FM-UE) score ≤ 56, and ability to perform the Graded Repetitive Arm Supplementary Program (GRASP). Patients received 15 sessions of 1Hz rTMS to contralesional M1 (at 120% RMT) or sham stimulation followed by 60 minutes GRASP, replacing standard-of care upper extremity task-specific therapy. Exploratory efficacy outcome was difference in FM-UE baseline to 30 days. A modified intention-to-treat analysis estimated the average treatment effect in 70 participants who received at least 1 treatment session using linear mixed-effects, controlling for baseline FM-UE, age, sex and lesion volume. Results 71% completed 15 sessions, 87% 10 or more 17% were lost to follow-up. Mean change in FM-UE was 10.2(±5.5) in the treatment and 10.8(±9.4) in the sham group. The adjusted treatment effect was −1.24 (−4.79, 2.32) indicating no additional rTMS-effect. Conclusions Implementing the CanStim consensus protocol in a sub-acute in-patient rehabilitation setting controlling the dose of task-specific therapy is feasible, but an add-on effect of rTMS on motor impairment was not observed. Conflict of interest
Edwards et al. (Fri,) studied this question.