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Temporal Interference Stimulation Combined With Tai Chi for Mild Cognitive Impairment

27 sierpnia 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

120

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Chiny
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Chiny, 200438
        • Rekrutacyjny
        • Shanghai University of Sport
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Urządzenie: 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.
Behawioralne: 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.
Eksperymentalny: 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.
Behawioralne: 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.
Urządzenie: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Montreal Cognitive Assessment (MoCA) Score
Ramy czasowe: 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.
Baseline, Week 8, and Week 24
Change in Mini-Mental State Examination (MMSE) Score
Ramy czasowe: 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.
Baseline, Week 8, and Week 24
Change in Go/No-Go Task Accuracy
Ramy czasowe: 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.
Baseline, Week 8
Change in Go/No-Go Task Reaction Time
Ramy czasowe: 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.
Baseline and Week 8
Change in n-back Task Accuracy
Ramy czasowe: 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.
Baseline, Week 8
Change in n-back Task Reaction Time
Ramy czasowe: 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.
Baseline, Week 8
Change in Digit Span Forward Score
Ramy czasowe: 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.
Baseline and Week 8
Change in Digit Span Backward Score
Ramy czasowe: 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.
Baseline and Week 8
Change in Auditory Verbal Learning Test Trial 1 Recall
Ramy czasowe: 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.
Baseline, Week 8, and Week 24
Change in Auditory Verbal Learning Test Trial 2 Recall
Ramy czasowe: 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.
Baseline, Week 8, and Week 24
Change in Auditory Verbal Learning Test Trial 3 Recall
Ramy czasowe: 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.
Baseline, Week 8, and Week 24
Change in Auditory Verbal Learning Test Trial 4 Recall
Ramy czasowe: 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.
Baseline, Week 8, and Week 24
Change in Auditory Verbal Learning Test Trial 5 Recall
Ramy czasowe: 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.
Baseline, Week 8, and Week 24
Change in Auditory Verbal Learning Test Recognition Correct Responses
Ramy czasowe: 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.
Baseline, Week 8, and Week 24
Change in Auditory Verbal Learning Test Recognition Errors
Ramy czasowe: 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.
Baseline, Week 8, and Week 24
Change in Face-Name Matching Task Accuracy
Ramy czasowe: 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.
Baseline, Week 8, and Week 24
Change in Face-Name Matching Task Reaction Time
Ramy czasowe: 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.
Baseline, Week 8, and Week 24
Change in Mnemonic Similarity Task Accuracy
Ramy czasowe: 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.
Baseline, Week 8, and Week 24
Change in Mnemonic Similarity Task Reaction Time
Ramy czasowe: 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.
Baseline, Week 8, and Week 24
Change in Single-Task Timed Up and Go Completion Time
Ramy czasowe: 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.
Baseline and Week 8
Change in Dual-Task Timed Up and Go Completion Time
Ramy czasowe: 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.
Baseline and Week 8
Change in Timed Up and Go Dual-Task Cost
Ramy czasowe: 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.
Baseline and Week 8
Change in Single-Task Gait Speed
Ramy czasowe: 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.
Baseline and Week 8
Change in Dual-Task Gait Speed
Ramy czasowe: 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.
Baseline and Week 8
Change in Single-Task Gait Cadence
Ramy czasowe: 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.
Baseline and Week 8
Change in Dual-Task Gait Cadence
Ramy czasowe: 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.
Baseline and Week 8
Change in Single-Task Stride Length
Ramy czasowe: Baseline and Week 8
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
Ramy czasowe: 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.
Baseline and Week 8
Change in Brain Structure and Function Assessed by Magnetic Resonance Imaging
Ramy czasowe: 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.
Baseline, Week 8
Change in Brain Structure and Function Assessed by Magnetic Resonance Imaging
Ramy czasowe: 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.
Baseline and Week 8

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in Hamilton Anxiety Rating Scale Score
Ramy czasowe: Baseline, Week 8, and Week 24
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.
Baseline, Week 8, and Week 24
Change in 17-Item Hamilton Depression Rating Scale Score
Ramy czasowe: Baseline, Week 8, and Week 24
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.
Baseline, Week 8, and Week 24
Change in 15-Item Geriatric Depression Scale Score
Ramy czasowe: Baseline, Week 8, and Week 24
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.
Baseline, Week 8, and Week 24
Change in Pittsburgh Sleep Quality Index Score
Ramy czasowe: Baseline, Week 8, and Week 24
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.
Baseline, Week 8, and Week 24
Change in Epworth Sleepiness Scale Score
Ramy czasowe: Baseline, Week 8, and Week 24
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.
Baseline, Week 8, and Week 24
Change in REM Sleep Behavior Disorder Screening Questionnaire Score
Ramy czasowe: Baseline, Week 8, and Week 24
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.
Baseline, Week 8, and Week 24
Change in Functional Activities Questionnaire Score
Ramy czasowe: Baseline, Week 8, and Week 24
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.
Baseline, Week 8, and Week 24
Change in 12-Item Short Form Health Survey Physical Component Summary Score
Ramy czasowe: Baseline, Week 8, and Week 24
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.
Baseline, Week 8, and Week 24
Change in Go/No-Go Task-Evoked Oxygenated Hemoglobin Response Assessed by fNIRS
Ramy czasowe: Baseline and Week 8
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.
Baseline and Week 8
Change in n-back Task-Evoked Oxygenated Hemoglobin Response Assessed by fNIRS
Ramy czasowe: Baseline and Week 8
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.
Baseline and Week 8
Change in Mnemonic Similarity Task-Evoked Oxygenated Hemoglobin Response Assessed by fNIRS
Ramy czasowe: Baseline and Week 8
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.
Baseline and Week 8
Blinding Effectiveness
Ramy czasowe: During the 8-week intervention period
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.
During the 8-week intervention period
Incidence and Severity of Adverse Events and Tolerability
Ramy czasowe: Throughout the 8-week intervention period and at the Week 24 follow-up
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.
Throughout the 8-week intervention period and at the Week 24 follow-up

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Shanghai University of Sport

Współpracownicy

Huashan Hospital

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

25 sierpnia 2026

Zakończenie podstawowe (Szacowany)

25 lipca 2027

Ukończenie studiów (Szacowany)

25 lipca 2027

Daty rejestracji na studia

Pierwszy przesłany

24 sierpnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

27 sierpnia 2026

Pierwszy wysłany (Rzeczywisty)

2 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

2 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

27 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 102772026RT012

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu 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.

Ramy czasowe udostępniania IPD

Beginning 6 months after publication of the main results.

Kryteria dostępu do udostępniania 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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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