Investigate the therapeutic differences between Temporal Interference Stimulation and Transcranial Alternating Current Stimulation on Post-stroke cognitive dysfunction: A Protocol for Clinical Trial

Abstract

Introduction Transcranial alternating current stimulation (tACS) and temporal interference stimulation (TIS) as electrical neuromodulation therapy, have shown promising applications in cognitive impairments. Meanwhile TIS technique is more novel with deep and non-invasive brain stimulation . At present, the therapeutic or neuromodulation differences between TIS with tACS on Post-stroke cognitive dysfunction(PSCI) is still unclear. Here, we aim to compare and analysis the neuromodulation model and clinical performances of TIS and tACS. Methods and analysis The prospective, single-blind and randomized controlled trial will be conducted over a two-week period. Through precise statistical sample size calculation,thirty-six eligible participants with mild PSCI will be recruited and randomly allocated to either the tACS or the TIS group. Participants in the TIS group will receive stimulation at frequencies of 2005Hz and 2010Hz with hippocampus target(in the hippocampal region). Those in the tACS group will undergo 5Hz stimulation of the dorsolateral prefrontal cortex (DLPFC). The intervention will last for two weeks, with each participants receiving 25-minute stimulation sessions once a day, five times per week. The primary outcome measure will be the Montreal cognitive assessment (MoCA), while secondary outcomes will include performance on the N-back task, digital span test (DST), shape trails test (STT) and functional near-infrared spectroscopy (fNIRS). All clinical assessments will be collected at two time points: pre-intervention (T1) and post-intervention (T2). Trial registration The trial protocol is registered with www.chictr.org.cn under protocol registration number ChiCTR2400081207.Registered February 26, 2024.