Repetitive peripheral magnetic stimulation combined with intensive physical therapy for gait disturbance after hemorrhagic stroke: an open-label case series.

In this pilot study, we aimed to determine the safety and feasibility of a 15-day protocol consisting of in-hospital repetitive peripheral magnetic stimulation (rPMS) combined with intensive physical therapy for the recovery of the gait disturbance in chronic stroke patients with lower limb hemiparesis. Seven hemorrhagic stroke patients with lower limb hemiparesis and gait disturbance (age: 50-78; time from onset of stroke: 7-107 months) were enrolled. rPMS was applied to the muscles of the paretic lower limb with a parabolic coil. A train of stimuli at a frequency of 20 Hz was applied for 3 s followed by a 27-s rest interval. Therapy with rPMS was performed with eighty such trains of stimuli (total 4800 pulses). Following rPMS therapy, 120 min of physical therapy was administrated daily. Each patient received this combination treatment over fifteen consecutive days, with the walking function of all participants assessed before and after the intervention. The proposed treatment protocol resulted in significant improvements in the walking speed, ambulation ability, and balance ability, but showed no significant effects on the endurance capacity, step length, and spasticity. No rPMS-related side effects were noted. Our protocol consisting of rPMS and intensive physical therapy appears well tolerated and feasible for therapy in hemorrhagic stroke patients with gait disturbance. Further large-scale studies are required to confirm its efficacy.

Dose-response of rPMS for upper Limb hemiparesis after stroke.

INTRODUCTION: Repetitive peripheral magnetic stimulation (rPMS) therapy is an innovative and minimally invasive neurorehabilitative technique and has been shown to facilitate neural plasticity. However, there is at present no research that clarifies the dose-response of rPMS therapy on the recovery of upper limb hemiparesis after stroke. This trial aims to clarify the dose-response of rPMS therapy combined with intensive occupational therapy (OT) for chronic stroke patients with moderate to severe upper limb hemiparesis. METHODS AND ANALYSIS: This multicenter, prospective, assessor-blinded, randomized controlled study with 3 parallel groups will be conducted from January 20, 2020 to September 30, 2022. Fifty patients will be randomly assigned in a ratio of 1:2:2 to the control group, the group receiving daily 2400 pulses of rPMS, or the group receiving daily 4800 pulses of rPMS, respectively. From the day after admission (Day 1), rPMS therapy and intensive OT will be initiated. The primary outcome is the change in the motor function of the affected upper extremity (Fugl-Meyer Assessment) between the time of admission (Day 0) and the day after 2 weeks of treatment (Day 14). Secondary outcomes will include the changes in spasticity, active range of motion, motor evoked potential, and activity of daily living. ETHICS AND DISSEMINATION: The study was approved by the Jikei University Certified Review Board for all institutions (reference number: JKI19-020). Results of the primary and secondary outcomes will be published in a peer-reviewed journal and presented at international congresses. The results will also be disseminated to patients. TRIAL REGISTRATION NUMBER: jRCTs032190191.