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Temporal Interference Stimulation Combined With Tai Chi for Mild Cognitive Impairment

ConditionMild Cognitive Impairment (MCI)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-80
SponsorShanghai University of Sport

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 60-80 years

Community-dwelling

Montreal Cognitive Assessment (MoCA) score < 26

Clinical Dementia Rating (CDR) score = 0.5

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Active tTIS Combined With Tai ChiExperimental treatment 2 interventions
Group B: Placebo tTIS Combined With Tai ChiExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in Montreal Cognitive Assessment (MoCA) Score

Global cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). The total score ranges from 0 to 30, with higher scores indicating better cognitive function. Changes from baseline will be evaluated after the intervention and at follow-up.

Time frame
Baseline, Week 8, and Week 24
2

Change in Mini-Mental State Examination (MMSE) Score

Global cognitive function will also be assessed using the Mini-Mental State Examination (MMSE). The total score ranges from 0 to 30, with higher scores indicating better cognitive function. Changes from baseline will be evaluated after the intervention and at follow-up.

Time frame
Baseline, Week 8, and Week 24
3

Change in Go/No-Go Task Accuracy

Inhibitory control will be assessed using accuracy on the Go/No-Go task. Accuracy will be expressed as the percentage of correct responses, with higher values indicating better performance.

Time frame
Baseline, Week 8
4

Change in Go/No-Go Task Reaction Time

Inhibitory control will be assessed using reaction time for correct responses on the Go/No-Go task. Reaction time will be recorded in milliseconds (ms), with shorter reaction times indicating faster task performance.

Time frame
Baseline and Week 8

Secondary outcomes

1

Change in Hamilton Anxiety Rating Scale Score

Anxiety symptoms will be assessed using the Hamilton Anxiety Rating Scale (HAM-A). The total score ranges from 0 to 56, with higher scores indicating greater anxiety symptom severity.

Time frame
Baseline, Week 8, and Week 24
2

Change in 17-Item Hamilton Depression Rating Scale Score

Depressive symptoms will be assessed using the 17-item Hamilton Depression Rating Scale (HAM-D-17). The total score ranges from 0 to 52, with higher scores indicating greater depressive symptom severity.

Time frame
Baseline, Week 8, and Week 24
3

Change in 15-Item Geriatric Depression Scale Score

Depressive symptoms will also be assessed using the 15-item Geriatric Depression Scale (GDS-15). The total score ranges from 0 to 15, with higher scores indicating greater depressive symptom severity.

Time frame
Baseline, Week 8, and Week 24
4

Change in Pittsburgh Sleep Quality Index Score

Subjective sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality.

Time frame
Baseline, Week 8, and Week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai University of Sport

Lead sponsor

Huashan Hospital

Collaborator

Source ClinicalTrials.gov
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