Daily high-frequency transcranial random noise stimulation (hf-tRNS) for sleep disturbances and cognitive dysfunction in patients with mild vascular cognitive impairments: A study protocol for a pilot randomized controlled trial.

BACKGROUND

Poor sleep quality is increasingly considered to be an underlying cause of cerebrovascular diseases. This is a slowly progressing condition that gradually leads to vascular cognitive impairment and stroke during ageing. At present, randomized clinical trials examining the non-pharmacological therapies in the management of this comorbidity are very limited. Transcranial current stimulation (tCS) is a non-invasive technology for promoting cognitive function and treating brain disorders. As advanced modalities of tCS, transcranial random noise stimulation (tRNS) and transcranial alternating current stimulation (tACS), could deliver frequency-specific waveforms of currents that can modulate brain activities in a more specific manner.

METHODS AND DESIGN

Chinese individuals between the ages of 60 and 90 years, who are right-handed and have mild vascular cognitive impairment (VCI) with sleep disturbances, will participate in a randomized study. They will undergo a 2-week intervention period where they will be randomly assigned to one of three groups: high-frequency (hf)-tRNS, 40 Hz tACS, or sham tCS. Each group will consist of 15 participants. Before the intervention, high-resolution magnetic resonance imaging (MRI) data will be used to create a computational head model for each participant. This will help identify the treatment target of left inferior parietal lobe (IPL). Throughout the study, comprehensive assessments will be conducted at multiple time points, including baseline, 2nd week, 6th week, and 12th week. These assessments will evaluate various factors such as sleep quality, domain-specific cognitive performance, and actigraphic records. In addition, the participants' adherence to the program and any potential adverse effects will be closely monitored throughout the duration of the intervention.

CONCLUSIONS

The primary objective of this study is to examine the safety, feasibility, and effectiveness of hf-tRNS and 40 Hz tACS interventions targeting left IPL in individuals with mild vascular cognitive impairment (VCI) who experience sleep disturbances and cognitive dysfunction. Additionally, the study seeks to evaluate the program's adherence, tolerability, and any potential adverse effects associated with frequency-specific transcranial current stimulation (tCS). The findings from this research will contribute to a deeper understanding of the intricate relationship between oscillation, sleep, and cognition. Furthermore, the results will provide valuable insights to guide future investigations in the field of sleep medicine and neurodegenerative diseases.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT06169254.