Temporal Interference Stimulation Combined With Tai Chi for Mild Cognitive Impairment
27 de agosto de 2026 actualizado 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Descripción detallada
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 estudio
Intervencionista
Inscripción (Estimado)
120
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Zhen Xu
- Número de teléfono: +86 135 0590 5809
- Correo electrónico: 2512516017@sus.edu.cn
Ubicaciones de estudio
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200438
- Reclutamiento
- Shanghai University of Sport
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Contacto:
- Zhen Xu
- Número de teléfono: +86 135 0590 5809
- Correo electrónico: 2512516017@sus.edu.cn
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Montreal Cognitive Assessment (MoCA) Score
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Hamilton Anxiety Rating Scale Score
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
25 de agosto de 2026
Finalización primaria (Estimado)
25 de julio de 2027
Finalización del estudio (Estimado)
25 de julio de 2027
Fechas de registro del estudio
Enviado por primera vez
24 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
27 de agosto de 2026
Publicado por primera vez (Actual)
2 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
2 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
27 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 102772026RT012
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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.
Marco de tiempo para compartir IPD
Beginning 6 months after publication of the main results.
Criterios de acceso compartido de 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .