Temporal Interference Stimulation Combined With Tai Chi for Mild Cognitive Impairment
27. srpna 2026 aktualizováno: 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.
Přehled studie
Postavení
Postavení
Nábor
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
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 studie
Typ studie
Intervenční
Zápis (Odhadovaný)
Zápis
120
Fáze
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
Studijní kontakt
- Jméno: Zhen Xu
- Telefonní číslo: +86 135 0590 5809
- E-mail: 2512516017@sus.edu.cn
Studijní místa
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Čína, 200438
- Nábor
- Shanghai University of Sport
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Kontakt:
- Zhen Xu
- Telefonní číslo: +86 135 0590 5809
- E-mail: 2512516017@sus.edu.cn
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Počet zbraní
2
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
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Experimentální: 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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Experimentální: 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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Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change in Montreal Cognitive Assessment (MoCA) Score
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Hamilton Anxiety Rating Scale Score
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Sponzor
Spolupracovníci
Spolupracovníci
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
Začátek studia
25. srpna 2026
Primární dokončení (Odhadovaný)
Primární dokončení
25. července 2027
Dokončení studie (Odhadovaný)
Dokončení studie
25. července 2027
Termíny zápisu do studia
První předloženo
První předloženo
24. srpna 2026
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
27. srpna 2026
První zveřejněno (Aktuální)
První zveřejněno
2. září 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
2. září 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
27. srpna 2026
Naposledy ověřeno
Naposledy ověřeno
1. srpna 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- 102772026RT012
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu 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.
Časový rámec sdílení IPD
Beginning 6 months after publication of the main results.
Kritéria přístupu pro sdílení 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.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .