Investigate the therapeutic differences between temporal interference stimulation and transcranial alternating current stimulation on post-stroke cognitive dysfunction: a protocol for a randomized controlled clinical trial

Transcranial alternating current stimulation (tACS) and temporal interference stimulation (TIS) as electrical neuromodulation therapy have shown promising applications in cognitive impairments. Meanwhile, the TIS technique is more novel, with deep and non-invasive brain stimulation. At present, the therapeutic or neuromodulation differences between TIS and tACS on post-stroke cognitive dysfunction(PSCI) are still unclear. Here, we aim to compare and analyze the neuromodulation model and clinical performances of TIS and tACS.

The prospective, single-blind and randomized controlled trial will be conducted over a 2-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 2005 Hz and 2010 Hz targeting the hippocampal region. Those in the tACS group will undergo 5 Hz stimulation of the dorsolateral prefrontal cortex (DLPFC). The intervention will last for 2 weeks, with each participant receiving 25-min 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).

The trial protocol is registered with www.chictr.org.cn under protocol registration number ChiCTR2400081207. Registered on February 26, 2024.