The Effects of Transcranial Temporal Interferential Electrical Stimulation on Cognitive Function, Dual-Task Performance and Neuroplasticity in Individuals With Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Montreal Cognitive Assessment (MoCA) Score
研究概览
简要总结
To explore the effects of transcranial temporal interference stimulation (tTIS) on cognitive function and dual-task walking performance, as well as its underlying neuroimaging mechanisms, in individuals with mild cognitive impairment.
详细描述
This is a randomized, double-blind, sham-controlled, crossover trial. Participants aged 60-80 years with mild cognitive impairment (MoCA < 26, CDR = 0.5) will receive a single 20-minute session of individualized 5 Hz transcranial temporal interference stimulation (tTIS) targeting the left hippocampus (2 mA, 2000/2005 Hz carriers) and a sham session in random order, with a 7-day washout period. The primary outcomes are change in MoCA score, dual-task gait/balance cost, and working memory performance. Secondary outcomes include change in brain function and brain structure. The study aims to enroll 40 participants. Safety and tolerability will be assessed via structured questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 60-80 years
- •Community-dwelling
- •Montreal Cognitive Assessment (MoCA) score < 26
- •Clinical Dementia Rating (CDR) score = 0.5
- •Activities of Daily Living (ADL) score < 26 (largely intact daily function)
- •Does not meet criteria for dementia diagnosis (based on DSM-5 or NIA-AA criteria)
- •No contraindications for MRI examination (no metallic implants, no claustrophobia)
- •Able to provide written informed consent
排除标准
- •Neurological conditions that may cause cognitive decline (e.g., cerebrovascular disease, encephalitis, Parkinson's disease, Huntington's disease)
- •Severe visual, auditory, or language impairments preventing completion of neuropsychological assessments
- •Severe depression (Geriatric Depression Scale > 10) or other major psychiatric disorders
- •History of seizures or epilepsy
- •Previous deep brain stimulation or electroconvulsive therapy within 6 months
- •Alcohol or substance dependence
- •Concurrent participation in another interventional clinical trial
- •Contraindications for non-invasive brain stimulation: electronic or ferromagnetic implants, non-MRI compatible metal implants, history of seizures, pregnancy
研究组 & 干预措施
Active TIS followed by Placebo TIS
Participants first receive single-session active TIS targeting the hippocampus for approx. 20 minutes. Following a washout period, they receive placebo (sham) TIS.
干预措施: Active Temporal Interference Stimulation (TIS) (Device)
Active TIS followed by Placebo TIS
Participants first receive single-session active TIS targeting the hippocampus for approx. 20 minutes. Following a washout period, they receive placebo (sham) TIS.
干预措施: Placebo / Sham TIS (Device)
Placebo TIS followed by Active TIS
Participants first receive single-session placebo (sham) TIS for approx. 20 minutes. Following a washout period, they receive active TIS targeting the hippocampus.
干预措施: Active Temporal Interference Stimulation (TIS) (Device)
Placebo TIS followed by Active TIS
Participants first receive single-session placebo (sham) TIS for approx. 20 minutes. Following a washout period, they receive active TIS targeting the hippocampus.
干预措施: Placebo / Sham TIS (Device)
结局指标
主要结局
Change in Montreal Cognitive Assessment (MoCA) Score
时间窗: Baseline and immediately after intervention
Change in Gait-Related and Balance-Related Dual-Task Cost
时间窗: Baseline and immediately after intervention
Change in Working Memory Performance
时间窗: Baseline and immediately after intervention
次要结局
- Change in Brain function(Baseline and immediately after intervention)
- Chang in Brain structure(Baseline and immediately after intervention)
研究者
Weijie Fu, Ph.D.
Professor
Shanghai University of Sport