Temporal Interference Stimulation Combined With Tai Chi for Mild Cognitive Impairment

Condition(s) studied

Investigational drug(s) / intervention(s)

Active Transcranial Temporal Interference Stimulation: 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: 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: 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 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.

Eligibility

Primary outcome measure(s)

• Change in Montreal Cognitive Assessment (MoCA) Score — Baseline, Week 8, and Week 24
  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.
• Change in Mini-Mental State Examination (MMSE) Score — Baseline, Week 8, and Week 24
  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.
• Change in Go/No-Go Task Accuracy — Baseline, Week 8
  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.
• Change in Go/No-Go Task Reaction Time — Baseline and Week 8
  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.
• Change in n-back Task Accuracy — Baseline, Week 8
  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.
• Change in n-back Task Reaction Time — Baseline, Week 8
  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.
• Change in Digit Span Forward Score — Baseline and Week 8
  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.
• Change in Digit Span Backward Score — Baseline and Week 8
  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.
• Change in Auditory Verbal Learning Test Trial 1 Recall — Baseline, Week 8, and Week 24
  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.
• Change in Auditory Verbal Learning Test Trial 2 Recall — Baseline, Week 8, and Week 24
  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.
• Change in Auditory Verbal Learning Test Trial 3 Recall — Baseline, Week 8, and Week 24
  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.
• Change in Auditory Verbal Learning Test Trial 4 Recall — Baseline, Week 8, and Week 24
  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.
• Change in Auditory Verbal Learning Test Trial 5 Recall — Baseline, Week 8, and Week 24
  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.
• Change in Auditory Verbal Learning Test Recognition Correct Responses — Baseline, Week 8, and Week 24
  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.
• Change in Auditory Verbal Learning Test Recognition Errors — Baseline, Week 8, and Week 24
  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.
• Change in Face-Name Matching Task Accuracy — Baseline, Week 8, and Week 24
  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.
• Change in Face-Name Matching Task Reaction Time — Baseline, Week 8, and Week 24
  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.
• Change in Mnemonic Similarity Task Accuracy — Baseline, Week 8, and Week 24
  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.
• Change in Mnemonic Similarity Task Reaction Time — Baseline, Week 8, and Week 24
  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.
• Change in Single-Task Timed Up and Go Completion Time — Baseline and Week 8
  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.
• Change in Dual-Task Timed Up and Go Completion Time — Baseline and Week 8
  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.
• Change in Timed Up and Go Dual-Task Cost — Baseline and Week 8
  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.
• Change in Single-Task Gait Speed — Baseline and Week 8
  Gait speed under single-task walking conditions will be recorded in meters per second (m/s). Higher gait speed indicates faster walking performance.
• Change in Dual-Task Gait Speed — Baseline and Week 8
  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.
• Change in Single-Task Gait Cadence — Baseline and Week 8
  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.
• Change in Dual-Task Gait Cadence — Baseline and Week 8
  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.
• Change in Single-Task Stride Length — Baseline and Week 8
  Stride length under single-task walking conditions will be recorded in meters (m). Greater values indicate longer stride length.
• Change in Dual-Task Stride Length — Baseline and Week 8
  Stride length during cognitive-motor dual-task walking will be recorded in meters (m). Greater values indicate longer stride length during dual-tasking.
• Change in Brain Structure and Function Assessed by Magnetic Resonance Imaging — Baseline, Week 8
  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.
• Change in Brain Structure and Function Assessed by Magnetic Resonance Imaging — Baseline and Week 8
  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.

Trial sites (1)

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