Effects of Transcranial Temporal Interference Stimulation on Cognitive Function in Mild Cognitive Impairment

Официальное название

The Effects of Transcranial Temporal Interferential Electrical Stimulation on Cognitive Function, Dual-Task Performance and Neuroplasticity in Individuals With Mild Cognitive Impairment

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Active Temporal Interference Stimulation (TIS)
  Active tTIS delivered via surface electrodes targeting the hippocampus. Parameters: 2 mA baseline-to-peak intensity, 20-minute duration with 30-second ramp-up and ramp-down. The stimulation protocol is individualized based on each participant's T1-weighted structural MRI using finite element modeling to optimize electric field distribution to the hippocampal target.
• Устройство Placebo / Sham TIS
  Sham stimulation delivered using the same electrode placement and parameters as active stimulation. To mimic the sensory experience without effective neuromodulation, active current is delivered only during the 30-second ramp-up and ramp-down periods. During the 20-minute stimulation period, no current is delivered. Participants are unable to distinguish sham from active stimulation based on sensation.

Первичные конечные точки

• Change in Montreal Cognitive Assessment (MoCA) Score [Срок оценки: Baseline and immediately after intervention]
• Change in Gait-Related and Balance-Related Dual-Task Cost [Срок оценки: Baseline and immediately after intervention]
• Change in Working Memory Performance [Срок оценки: Baseline and immediately after intervention]

Вторичные конечные точки (2)

• Change in Brain function [Срок оценки: Baseline and immediately after intervention]
• Chang in Brain structure [Срок оценки: Baseline and immediately after intervention]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai University of Sport — Шанхай

Идентификаторы

NCT: NCT07519798 · 102772025RT208 · ChiCTR2600119709

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)
• ChiCTR ChiCTR2600119709 (Китайский реестр КИ)

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