Temporal Interference Stimulation Combined With Tai Chi for Mild Cognitive Impairment
27 de agosto de 2026 atualizado por: Weijie Fu, Ph.D., Shanghai University of Sport
Effects of Transcranial Temporal Interference Stimulation Combined With Tai Chi Training on Cognitive Function, Dual-Task Performance, and Neuroimaging Mechanisms in Individuals With Mild Cognitive Impairment
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.
Visão geral do estudo
Status
Recrutamento
Condições
Descrição detalhada
This is a randomized, quadruple-blind, sham-controlled, parallel-group trial involving approximately 120 individuals aged 60-80 years with mild cognitive impairment.
Participants will be randomly assigned to receive either active or sham individualized transcranial temporal interference stimulation (tTIS) combined with Tai Chi training for 8 weeks, three sessions per week.
Individualized tTIS will target the left hippocampus based on participant-specific T1-weighted MRI and finite element modeling, using a 5-Hz interference frequency generated by 2000- and 2005-Hz carrier frequencies at an intensity of 2 mA for 20 minutes per session; each Tai Chi session will last approximately 60 minutes.
Global cognition, episodic memory, neuropsychiatric symptoms, functional status, and health-related quality of life will be assessed at baseline, after the 8-week intervention, and at a 16-week post-intervention follow-up.
Working memory and executive control, dual-task performance, and neuroimaging outcomes will be assessed at baseline and after the 8-week intervention, with safety, tolerability, and blinding effectiveness monitored throughout the study.
Tipo de estudo
Intervencional
Inscrição (Estimado)
120
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Zhen Xu
- Número de telefone: +86 135 0590 5809
- E-mail: 2512516017@sus.edu.cn
Locais de estudo
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200438
- Recrutamento
- Shanghai University of Sport
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Contato:
- Zhen Xu
- Número de telefone: +86 135 0590 5809
- E-mail: 2512516017@sus.edu.cn
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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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.
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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.
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.
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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.
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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.
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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Montreal Cognitive Assessment (MoCA) Score
Prazo: Baseline, Week 8, and Week 24
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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.
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Baseline, Week 8, and Week 24
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Change in Mini-Mental State Examination (MMSE) Score
Prazo: Baseline, Week 8, and Week 24
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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.
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Baseline, Week 8, and Week 24
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Change in Go/No-Go Task Accuracy
Prazo: Baseline, Week 8
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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.
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Baseline, Week 8
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Change in Go/No-Go Task Reaction Time
Prazo: Baseline and Week 8
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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.
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Baseline and Week 8
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Change in n-back Task Accuracy
Prazo: Baseline, Week 8
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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.
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Baseline, Week 8
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Change in n-back Task Reaction Time
Prazo: Baseline, Week 8
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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.
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Baseline, Week 8
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Change in Digit Span Forward Score
Prazo: Baseline and Week 8
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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.
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Baseline and Week 8
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Change in Digit Span Backward Score
Prazo: Baseline and Week 8
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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.
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Baseline and Week 8
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Change in Auditory Verbal Learning Test Trial 1 Recall
Prazo: Baseline, Week 8, and Week 24
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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.
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Baseline, Week 8, and Week 24
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Change in Auditory Verbal Learning Test Trial 2 Recall
Prazo: Baseline, Week 8, and Week 24
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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.
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Baseline, Week 8, and Week 24
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Change in Auditory Verbal Learning Test Trial 3 Recall
Prazo: Baseline, Week 8, and Week 24
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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.
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Baseline, Week 8, and Week 24
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Change in Auditory Verbal Learning Test Trial 4 Recall
Prazo: Baseline, Week 8, and Week 24
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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.
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Baseline, Week 8, and Week 24
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Change in Auditory Verbal Learning Test Trial 5 Recall
Prazo: Baseline, Week 8, and Week 24
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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.
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Baseline, Week 8, and Week 24
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Change in Auditory Verbal Learning Test Recognition Correct Responses
Prazo: Baseline, Week 8, and Week 24
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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.
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Baseline, Week 8, and Week 24
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Change in Auditory Verbal Learning Test Recognition Errors
Prazo: Baseline, Week 8, and Week 24
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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.
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Baseline, Week 8, and Week 24
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Change in Face-Name Matching Task Accuracy
Prazo: Baseline, Week 8, and Week 24
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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.
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Baseline, Week 8, and Week 24
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Change in Face-Name Matching Task Reaction Time
Prazo: Baseline, Week 8, and Week 24
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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.
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Baseline, Week 8, and Week 24
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Change in Mnemonic Similarity Task Accuracy
Prazo: Baseline, Week 8, and Week 24
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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.
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Baseline, Week 8, and Week 24
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Change in Mnemonic Similarity Task Reaction Time
Prazo: Baseline, Week 8, and Week 24
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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.
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Baseline, Week 8, and Week 24
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Change in Single-Task Timed Up and Go Completion Time
Prazo: Baseline and Week 8
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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.
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Baseline and Week 8
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Change in Dual-Task Timed Up and Go Completion Time
Prazo: Baseline and Week 8
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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.
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Baseline and Week 8
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Change in Timed Up and Go Dual-Task Cost
Prazo: Baseline and Week 8
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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.
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Baseline and Week 8
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Change in Single-Task Gait Speed
Prazo: Baseline and Week 8
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Gait speed under single-task walking conditions will be recorded in meters per second (m/s).
Higher gait speed indicates faster walking performance.
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Baseline and Week 8
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Change in Dual-Task Gait Speed
Prazo: Baseline and Week 8
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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.
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Baseline and Week 8
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Change in Single-Task Gait Cadence
Prazo: Baseline and Week 8
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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.
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Baseline and Week 8
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Change in Dual-Task Gait Cadence
Prazo: Baseline and Week 8
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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.
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Baseline and Week 8
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Change in Single-Task Stride Length
Prazo: Baseline and Week 8
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Stride length under single-task walking conditions will be recorded in meters (m).
Greater values indicate longer stride length.
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Baseline and Week 8
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Change in Dual-Task Stride Length
Prazo: Baseline and Week 8
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Stride length during cognitive-motor dual-task walking will be recorded in meters (m).
Greater values indicate longer stride length during dual-tasking.
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Baseline and Week 8
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Change in Brain Structure and Function Assessed by Magnetic Resonance Imaging
Prazo: Baseline, Week 8
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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.
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Baseline, Week 8
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Change in Brain Structure and Function Assessed by Magnetic Resonance Imaging
Prazo: Baseline and Week 8
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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.
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Baseline and Week 8
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Hamilton Anxiety Rating Scale Score
Prazo: Baseline, Week 8, and Week 24
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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.
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Baseline, Week 8, and Week 24
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Change in 17-Item Hamilton Depression Rating Scale Score
Prazo: Baseline, Week 8, and Week 24
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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.
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Baseline, Week 8, and Week 24
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Change in 15-Item Geriatric Depression Scale Score
Prazo: Baseline, Week 8, and Week 24
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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.
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Baseline, Week 8, and Week 24
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Change in Pittsburgh Sleep Quality Index Score
Prazo: Baseline, Week 8, and Week 24
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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.
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Baseline, Week 8, and Week 24
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Change in Epworth Sleepiness Scale Score
Prazo: Baseline, Week 8, and Week 24
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Daytime sleepiness will be assessed using the Epworth Sleepiness Scale (ESS).
The total score ranges from 0 to 24, with higher scores indicating greater daytime sleepiness.
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Baseline, Week 8, and Week 24
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Change in REM Sleep Behavior Disorder Screening Questionnaire Score
Prazo: Baseline, Week 8, and Week 24
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Symptoms related to REM sleep behavior disorder will be assessed using the REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ).
The total score ranges from 0 to 13, with higher scores indicating more symptoms suggestive of REM sleep behavior disorder.
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Baseline, Week 8, and Week 24
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Change in Functional Activities Questionnaire Score
Prazo: Baseline, Week 8, and Week 24
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Daily functional ability will be assessed using the Functional Activities Questionnaire (FAQ).
The total score ranges from 0 to 30, with higher scores indicating greater impairment in instrumental activities of daily living.
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Baseline, Week 8, and Week 24
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Change in 12-Item Short Form Health Survey Physical Component Summary Score
Prazo: Baseline, Week 8, and Week 24
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Physical health-related quality of life will be assessed using the Physical Component Summary (PCS) score of the 12-Item Short Form Health Survey (SF-12).
The PCS is a norm-based summary score, with higher scores indicating better physical health-related quality of life.
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Baseline, Week 8, and Week 24
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Change in Go/No-Go Task-Evoked Oxygenated Hemoglobin Response Assessed by fNIRS
Prazo: Baseline and Week 8
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Task-evoked cerebral hemodynamic response during the Go/No-Go task will be assessed using functional near-infrared spectroscopy (fNIRS).
The primary fNIRS measure will be the task-related change in oxygenated hemoglobin (HbO) concentration in predefined cortical regions.
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Baseline and Week 8
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Change in n-back Task-Evoked Oxygenated Hemoglobin Response Assessed by fNIRS
Prazo: Baseline and Week 8
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Task-evoked cerebral hemodynamic response during the n-back task will be assessed using functional near-infrared spectroscopy (fNIRS).
The primary fNIRS measure will be the task-related change in oxygenated hemoglobin (HbO) concentration in predefined cortical regions.
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Baseline and Week 8
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Change in Mnemonic Similarity Task-Evoked Oxygenated Hemoglobin Response Assessed by fNIRS
Prazo: Baseline and Week 8
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Task-evoked cerebral hemodynamic response during the Mnemonic Similarity Task (MST) will be assessed using functional near-infrared spectroscopy (fNIRS).
The primary fNIRS measure will be the task-related change in oxygenated hemoglobin (HbO) concentration in predefined cortical regions.
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Baseline and Week 8
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Blinding Effectiveness
Prazo: During the 8-week intervention period
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Blinding effectiveness will be assessed by asking participants to indicate whether they believe they received active or sham transcranial temporal interference stimulation.
Participants' treatment guesses will be used to evaluate the success of participant blinding.
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During the 8-week intervention period
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Incidence and Severity of Adverse Events and Tolerability
Prazo: Throughout the 8-week intervention period and at the Week 24 follow-up
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Adverse events and tolerability will be assessed using structured questionnaires and participant reports.
The occurrence, type, and severity of stimulation-related adverse events and discomfort will be recorded, including symptoms such as tingling, itching, headache, dizziness, or other reported adverse effects.
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Throughout the 8-week intervention period and at the Week 24 follow-up
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
25 de agosto de 2026
Conclusão Primária (Estimado)
25 de julho de 2027
Conclusão do estudo (Estimado)
25 de julho de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
24 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
27 de agosto de 2026
Primeira postagem (Real)
2 de setembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
2 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
27 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 102772026RT012
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
De-identified individual participant data for primary and secondary outcome measures will be made available upon reasonable request to the corresponding author after publication of the main results.
Prazo de Compartilhamento de IPD
Beginning 6 months after publication of the main results.
Critérios de acesso de compartilhamento IPD
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.
Informações sobre medicamentos e dispositivos, documentos de estudo
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