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Enrolling by invitation NCT07519798

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

No phase Interventional Mild Cognitive Impairment (MCI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active Temporal Interference Stimulation (TIS), Placebo / Sham TIS.
Who it may be relevant to
Registry conditions: Mild Cognitive Impairment (MCI). Basic parameters: 60 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Device 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.
  • Device 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.

Primary outcome measures

  • 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 outcome measures (2)
  • Change in Brain function [Time frame: Baseline and immediately after intervention]
  • Chang in Brain structure [Time frame: Baseline and immediately after intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai University of Sport — Shanghai

Identifiers

NCT: NCT07519798 · 102772025RT208 · ChiCTR2600119709

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗