The Effects of Transcranial Temporal Interferential Electrical Stimulation on Cognitive Function, Dual-Task Performance and Neuroplasticity in Individuals With Mild Cognitive Impairment
Overview
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Shanghai University of Sport
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change in Montreal Cognitive Assessment (MoCA) Score
Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: Placebo / Sham TIS (Device)
Outcomes
Primary Outcomes
Change in Montreal Cognitive Assessment (MoCA) Score
Time Frame: Baseline and immediately after intervention
Change in Gait-Related and Balance-Related Dual-Task Cost
Time Frame: Baseline and immediately after intervention
Change in Working Memory Performance
Time Frame: Baseline and immediately after intervention
Secondary Outcomes
- Change in Brain function(Baseline and immediately after intervention)
- Chang in Brain structure(Baseline and immediately after intervention)
Investigators
Weijie Fu, Ph.D.
Professor
Shanghai University of Sport