rTMS for poststroke pusher syndrome: study protocol for a randomised, patient-blinded controlled clinical trial

Abstract

Introduction: Poststroke pusher syndrome (PS) prevalence is high. Patients with PS require longer rehabilitation with prolonged length of stay. Effective treatment of PS remains a challenge for rehabilitation professionals. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technique that is effective and recommended in the clinical guidelines of stroke rehabilitation. However, the role of rTMS for PS has not been examined. The study is to assess the efficacy of a specific rTMS programme for patients with PS in reducing pushing behaviour, enhancing motor recovery and improving mobility, as well as testing the safety of rTMS for patients with PS.

Methods and analysis: A randomised, patient and assessor blinded sham-controlled trial with two parallel groups will be conducted. Thirty-four eligible patients with PS will be randomly allocated to receive either rTMS or sham rTMS for 3 weeks. The primary assessment outcome is the pushing behaviour measured by the Burke Lateropulsion Scale and Scale for Contraversive Pushing. The secondary outcomes are the motor functions and mobility measured by the Fugl-Meyer Assessment Scale (motor domain) and Modified Rivermead Mobility Index, and any adverse events. Assessment will be performed at baseline and 1 week, 2 weeks and 3 weeks after intervention. Repeated-measures analysis of variance will be used for data analysis with the level of significance level set at 0.05.

Ethics and dissemination: The protocol has been approved by the Biomedical Ethics Committee of West China Hospital, Sichuan University on 23 March 2022 (2022-133). The trial findings will be published in peer-reviewed journals.

Trial registration number: Chinese Clinical Trial Registry (ChiCTR2200058015).

Keywords: NEUROLOGY; REHABILITATION MEDICINE; Stroke.

Figure 1

The flow diagram of the study. T0, baseline assessment; T1: after 1 week of intervention; T2: after 2 weeks of intervention; T3: after 3 weeks of intervention. AEs, adverse events; BLS, Burke Lateropulsion Scale; FMA-m, Fugl-Meyer Assessment Scale-motor domain; MRMI, Modified Rivermead Mobility Index; PS, pusher syndrome; S-rTMS, sham repetitive transcranial magnetic stimulation group; SAEs, serious adverse events; SCP, Scale for Contraversive Pushing; T-rTMS, true repetitive transcranial magnetic stimulation group.