Temporal Interference Stimulation Combined With Tai Chi for Mild Cognitive Impairment

Sponsor
Shanghai University of Sport
Study ID
NCT07799584
Status
Recruiting

Conditions

  • Mild Cognitive Impairment (MCI)

Eligibility Criteria

Sex
ALL
Age
60 Years - 80 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Sep 2, 2026
Start date
Aug 25, 2026
Status verified
Aug 2026
Primary completion
Jul 25, 2027
Completion
Jul 25, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active tTIS Combined With Tai Chi
    Participants will receive active individualized hippocampal transcranial temporal interference stimulation (tTIS) combined with Tai Chi training for 8 weeks, three sessions per week. Each tTIS session will last 20 minutes and each Tai Chi session approximately 60 minutes.
  • Experimental: Placebo tTIS Combined With Tai Chi
    Participants will receive sham individualized hippocampal transcranial temporal interference stimulation (tTIS) combined with the same Tai Chi training for 8 weeks, three sessions per week. Placebo (sham) stimulation will use the same electrode configuration and session duration as active stimulation but without effective stimulation during the main stimulation period.

Primary Outcome Measure

Change in Montreal Cognitive Assessment (MoCA) Score [ Time Frame: Baseline, Week 8, and Week 24 ]

Central Contacts

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