Intermittent theta burst stimulation for poststroke non-spatial attention deficit: a protocol of prospective, double-blinded, single-centre, randomised controlled trial in China

Abstract

Introduction Attention deficit is the most common cognitive impairment after stroke, which can significantly hinder the recovery of both other cognitive domains and motor functions. Increasing evidence suggests that the left dorsolateral prefrontal cortex (DLPFC) is related to non-spatial attention functions, which indicates that it may be a promising target of repetitive transcranial magnetic stimulation (rTMS) for treating poststroke non-spatial attention deficit. Theta burst stimulation (TBS) is a modified pattern of rTMS that delivers shorter stimulation times and exhibits superior therapeutic efficacy. This study aims to provide evidence regarding the efficacy of intermittent TBS (iTBS) over the left DLPFC to improve poststroke non-spatial attention deficits and elucidate the potential neurophysiological mechanisms. Methods and analysis In this single-centre, prospective, randomised, sham-controlled clinical trial, patients with non-spatial attention deficits (n=38) received 10 sessions of real iTBS (n=19) or sham iTBS (n=19) over the left DLPFC and a 30-min conventional attention training. Neuropsychological evaluations, electrophysiological examination and neuroimaging scan will be conducted at baseline, postintervention (second week) and 2-week follow-up (fourth week). The primary outcomes are the change in the Montreal Cognitive Assessment scores and the Digital Span Test scores from baseline to the end of the intervention (second week). The secondary outcomes comprise changes in magnetic resonance spectroscopy neuroimaging from baseline to the end of the intervention (second week) as well as attention test batteries (including tests of selective attention, sustained attention, divided attention and shifting attention) and ERP P300 from baseline to endpoint (fourth week). Ethics and dissemination This study has been approved by the Institutional Ethical Committee of Tongji Hospital (ID: TJ-IRB20230879). All participants will sign the informed consent. Findings will be published in peer-reviewed journals and conference presentations. Trial registration number ChiCTR2300068669.