Temporal Interference Stimulation Combined With Tai Chi for Mild Cognitive Impairment

NCT07799584 | Recruiting DMC

• 1 other identifier: 102772026RT012
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mild Cognitive Impairment (MCI)

Outcome Measures

Primary Outcomes (30)

• 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.

  Baseline, Week 8, and Week 24

• 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.

  Baseline, Week 8, and Week 24

• 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.

  Baseline, Week 8

• 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.

  Baseline and Week 8

• Change in n-back Task Accuracy

  Working memory performance will be assessed using accuracy on the n-back task. Accuracy will be expressed as the percentage of correct responses, with higher values indicating better performance.

  Baseline, Week 8

• Change in n-back Task Reaction Time

  Working memory performance will be assessed using reaction time for correct responses on the n-back task. Reaction time will be recorded in milliseconds (ms), with shorter reaction times indicating faster task performance.

  Baseline, Week 8

• Change in Digit Span Forward Score

  Attention and short-term memory will be assessed using the Digit Span Forward task. Performance will be recorded as the raw Digit Span Forward score, with higher scores indicating better performance.

  Baseline and Week 8

• Change in Digit Span Backward Score

  Working memory will be assessed using the Digit Span Backward task. Performance will be recorded as the raw Digit Span Backward score, with higher scores indicating better performance.

  Baseline and Week 8

• Change in Auditory Verbal Learning Test Trial 1 Recall

  Immediate verbal memory will be assessed using the number of words correctly recalled during Trial 1 (N1) of the Auditory Verbal Learning Test (AVLT). Higher numbers of correctly recalled words indicate better memory performance.

  Baseline, Week 8, and Week 24

• Change in Auditory Verbal Learning Test Trial 2 Recall

  Verbal learning performance will be assessed using the number of words correctly recalled during Trial 2 (N2) of the Auditory Verbal Learning Test (AVLT). Higher numbers of correctly recalled words indicate better performance.

  Baseline, Week 8, and Week 24

• Change in Auditory Verbal Learning Test Trial 3 Recall

  Verbal learning performance will be assessed using the number of words correctly recalled during Trial 3 (N3) of the Auditory Verbal Learning Test (AVLT). Higher numbers of correctly recalled words indicate better performance.

  Baseline, Week 8, and Week 24

• Change in Auditory Verbal Learning Test Trial 4 Recall

  Verbal learning performance will be assessed using the number of words correctly recalled during Trial 4 (N4) of the Auditory Verbal Learning Test (AVLT). Higher numbers of correctly recalled words indicate better performance.

  Baseline, Week 8, and Week 24

• Change in Auditory Verbal Learning Test Trial 5 Recall

  Verbal learning performance will be assessed using the number of words correctly recalled during Trial 5 (N5) of the Auditory Verbal Learning Test (AVLT). Higher numbers of correctly recalled words indicate better performance.

  Baseline, Week 8, and Week 24

• Change in Auditory Verbal Learning Test Recognition Correct Responses

  Recognition memory will be assessed using the number of correct recognition responses on the Auditory Verbal Learning Test (AVLT). A higher number of correct recognition responses indicates better recognition memory.

  Baseline, Week 8, and Week 24

• Change in Auditory Verbal Learning Test Recognition Errors

  Recognition memory errors will be assessed using the number of incorrect recognition responses on the Auditory Verbal Learning Test (AVLT). A lower number of recognition errors indicates better recognition memory performance.

  Baseline, Week 8, and Week 24

• Change in Face-Name Matching Task Accuracy

  Associative episodic memory will be assessed using accuracy on the face-name matching task. Accuracy will be expressed as the percentage of correct responses, with higher values indicating better performance.

  Baseline, Week 8, and Week 24

• Change in Face-Name Matching Task Reaction Time

  Associative episodic memory performance will be assessed using reaction time for correct responses on the face-name matching task. Reaction time will be recorded in milliseconds (ms), with shorter reaction times indicating faster task performance.

  Baseline, Week 8, and Week 24

• Change in Mnemonic Similarity Task Accuracy

  Episodic memory and mnemonic discrimination will be assessed using accuracy on the Mnemonic Similarity Task (MST). Accuracy will be expressed as the percentage of correct responses, with higher values indicating better performance.

  Baseline, Week 8, and Week 24

• Change in Mnemonic Similarity Task Reaction Time

  Performance on the Mnemonic Similarity Task (MST) will also be assessed using reaction time for correct responses. Reaction time will be recorded in milliseconds (ms), with shorter reaction times indicating faster task performance.

  Baseline, Week 8, and Week 24

• Change in Single-Task Timed Up and Go Completion Time

  Mobility under single-task conditions will be assessed using the Timed Up and Go (TUG) test. Completion time will be recorded in seconds, with shorter completion times indicating better mobility performance.

  Baseline and Week 8

• Change in Dual-Task Timed Up and Go Completion Time

  Cognitive-motor dual-task performance will be assessed using the Timed Up and Go (TUG) test performed concurrently with a cognitive task. Completion time will be recorded in seconds, with shorter completion times indicating better dual-task mobility performance.

  Baseline and Week 8

• Change in Timed Up and Go Dual-Task Cost

  Dual-task cost for Timed Up and Go completion time will be calculated as \[(dual-task completion time - single-task completion time) / single-task completion time\] × 100%. Higher positive values indicate greater deterioration in mobility performance under dual-task conditions.

  Baseline and Week 8

• Change in Single-Task Gait Speed

  Gait speed under single-task walking conditions will be recorded in meters per second (m/s). Higher gait speed indicates faster walking performance.

  Baseline and Week 8

• Change in Dual-Task Gait Speed

  Gait speed during cognitive-motor dual-task walking will be recorded in meters per second (m/s). Higher gait speed indicates faster walking performance during dual-tasking.

  Baseline and Week 8

• Change in Single-Task Gait Cadence

  Gait cadence under single-task walking conditions will be recorded as steps per minute (steps/min). Higher values indicate a greater number of steps performed per minute.

  Baseline and Week 8

• Change in Dual-Task Gait Cadence

  Gait cadence during cognitive-motor dual-task walking will be recorded as steps per minute (steps/min). Higher values indicate a greater number of steps performed per minute during dual-tasking.

  Baseline and Week 8

• Change in Single-Task Stride Length

  Stride length under single-task walking conditions will be recorded in meters (m). Greater values indicate longer stride length.

  Baseline and Week 8

• Change in Dual-Task Stride Length

  Stride length during cognitive-motor dual-task walking will be recorded in meters (m). Greater values indicate longer stride length during dual-tasking.

  Baseline and Week 8

• Change in Brain Structure and Function Assessed by Magnetic Resonance Imaging

  Changes in brain structure and function will be assessed using multimodal magnetic resonance imaging (MRI). MRI-derived structural and functional measures will be used to characterize intervention-related brain changes.

  Baseline, Week 8

• Change in Brain Structure and Function Assessed by Magnetic Resonance Imaging

  Changes in brain structure and function will be assessed using multimodal magnetic resonance imaging (MRI). MRI-derived structural and functional measures will be used to characterize intervention-related brain changes.

  Baseline and Week 8

Secondary Outcomes (13)

• Change in Hamilton Anxiety Rating Scale Score

  Baseline, Week 8, and Week 24

• Change in 17-Item Hamilton Depression Rating Scale Score

  Baseline, Week 8, and Week 24

• Change in 15-Item Geriatric Depression Scale Score

  Baseline, Week 8, and Week 24

• Change in Pittsburgh Sleep Quality Index Score

  Baseline, Week 8, and Week 24

• Change in Epworth Sleepiness Scale Score

  Baseline, Week 8, and Week 24

Study Arms (2)

Active tTIS Combined With Tai Chi

EXPERIMENTAL

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.

Device: Active Transcranial Temporal Interference Stimulation; Behavioral: Tai Chi Training

Placebo tTIS Combined With Tai Chi

EXPERIMENTAL

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.

Device: Placebo Transcranial Temporal Interference Stimulation; Behavioral: Tai Chi Training

Interventions

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.

Placebo tTIS Combined With Tai Chi

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.

Active tTIS Combined With Tai Chi; Placebo tTIS Combined With Tai Chi

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.

Active tTIS Combined With Tai Chi

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai University of Sport: lead
• Huashan Hospital: collaborator

Study Sites (1)

Shanghai University of Sport

Shanghai, Shanghai Municipality, 200438, China

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Zhen Xu

CONTACT

+86 135 0590 5809; 2512516017@sus.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: September 2, 2026
• Study Start: August 25, 2026
• Primary Completion (Estimated): July 25, 2027
• Study Completion (Estimated): July 25, 2027
• Last Updated: September 2, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 6 months after publication of the main results.
• Access Criteria: Data will be made available upon reasonable request to the corresponding author. Data will be shared with researchers who submit a methodologically sound research proposal and intend to use the data for non-commercial purposes. Applicants must sign a data access agreement.

Locations

CN (1)