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RECRUITING Not applicable ClinicalTrials.gov

Temporal Interference Stimulation Combined With Tai Chi for Mild Cognitive Impairment

Sponsor: Shanghai University of Sport • ClinicalTrials.gov ID: NCT07799584

Registry updated: 2026-09-02
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Description

This study aims to evaluate whether individualized hippocampal transcranial temporal interference stimulation (tTIS) combined with Tai Chi training can improve cognitive function and dual-task performance in individuals with mild cognitive impairment. Participants will be randomly assigned to receive either active or sham individualized tTIS combined with Tai Chi training for 8 weeks. The study will also investigate changes in brain structure and function using neuroimaging and assess whether the intervention effects are maintained during follow-up.

Interventions

  • Active Transcranial Temporal Interference Stimulation (Device)
    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. Stimulation will be administered three times per week for 8 weeks.
  • Placebo Transcranial Temporal Interference Stimulation (Device)
    Placebo 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. Sham stimulation will be administered three times per week for 8 weeks.
  • Tai Chi Training (Behavioral)
    Participants will receive standardized Tai Chi training for approximately 60 minutes per session, three sessions per week for 8 weeks. The same Tai Chi training protocol will be provided to participants in both study arms.

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

Conditions

Mild Cognitive Impairment (MCI)

Locations

  • Shanghai University of Sport — Shanghai, Shanghai Municipality, China
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record