Hippocampal Temporal Interference Stimulation for Memory and Dual-Task Postural Control in Older Adults With Mild Cognitive Impairment
13 sierpnia 2026 zaktualizowane przez: Jiaojiao Lü, PhD, Shanghai University of Sport
Effects and Underlying Mechanisms of Hippocampal-Targeted Temporal Interference Stimulation on Memory Function and Dual-Task Postural Control in Older Adults With Mild Cognitive Impairment
This trial aims to investigate whether a single session of 40 Hz hippocampal temporal interference stimulation can improve memory function and dual-task postural control among older adults with mild cognitive impairment (MCI). The primary research questions to be addressed are as follows:
- Can 40 Hz hippocampal temporal interference stimulation boost memory test performance in older adults with MCI?
- Can 40 Hz hippocampal temporal interference stimulation improve walking and balance ability under dual-task conditions in older adults with MCI? Researchers will compare active 40 Hz hippocampal temporal interference stimulation against sham stimulation to identify whether this intervention yields positive immediate effects on memory function and dual-task postural control.
Participants will be required to:
- Attend three laboratory visits over approximately three weeks, and receive one session of active stimulation and one session of sham stimulation in random order, with an interval of at least seven days between the two stimulation visits;
- Complete memory and motor function assessments before and after each stimulation session;
- Undergo functional magnetic resonance imaging (fMRI) scans to detect changes in brain activity.
Przegląd badań
Status
Rekrutacyjny
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Szacowany)
21
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
- Nazwa: Jiaojiao Lü, PhD
- Numer telefonu: +86 18516565889
- E-mail: ljj27@163.com
Lokalizacje studiów
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Chiny, 200438
- Rekrutacyjny
- Shanghai University of Sport
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Kontakt:
- Ethics Committee of the Shanghai University of Sport
- Numer telefonu: +86 21 65508179
- E-mail: lunli@sus.edu.cn
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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
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
- Aged 65 years or older;
- Presence of subjective memory complaints;
- Objective cognitive impairment: screened using the Montreal Cognitive Assessment-Bejingversion (MoCA-BJ). The MoCA-BJ total score is 30 points. For individuals with <12 years ofeducation, 1 point is added to the raw total score (corrected total score capped at 30 points); acorrected total score <26 points indicates risk of cognitive impairment;
- Clinical Dementia Rating (CDR) score of 0.5;
- Does not meet diagnostic criteria for dementia: Mini-Mental State Examination (MMSE) scores>18 for illiterate individuals, 221 for those with primary school education, and >25 for those withjunior high school education or above;6. Retains independent activities of daily living (ADL) and is capable of cooperating with allassessments and interventions.
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: Zadanie krzyżowe
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: TIs Arm
Participants receive a single 20-minute session of active 40 Hz temporal interference stimulation (TIS) targeting the left hippocampus.
In this randomized crossover design, each participant also undergoes a sham session on a separate visit, with at least 7 days between sessions.
Memory, dual-task postural control, and fMRI assessments are conducted before and after each session.
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Transcranial temporal interference stimulation (TIS) is a noninvasive brain stimulation technique.
In this randomized crossover trial, each participant receives two sessions in random order: one active 40 Hz TIS session targeting the left hippocampus and one sham session, with at least 7 days between sessions.
Each session lasts 20 minutes.
Outcome measures include memory tests, dual-task postural control assessments, and fMRI scans, conducted before and immediately after each session.
Inne nazwy:
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Pozorny komparator: sham group
Participants receive a single 20-minute session of sham TIS using identical electrode placement and setup, but without effective 40 Hz stimulation.
In this randomized crossover design, each participant also undergoes an active TIS session on a separate visit, with at least 7 days between sessions.
Memory, dual-task postural control, and fMRI assessments are conducted before and after each session.
|
Transcranial temporal interference stimulation (TIS) is a noninvasive brain stimulation technique.
In this randomized crossover trial, each participant receives two sessions in random order: one active 40 Hz TIS session targeting the left hippocampus and one sham session, with at least 7 days between sessions.
Each session lasts 20 minutes.
Outcome measures include memory tests, dual-task postural control assessments, and fMRI scans, conducted before and immediately after each session.
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change From Pre-intervention in Object-Scene Associative Memory Retrieval Accuracy After Stimulation
Ramy czasowe: Immediately before and after each 20-minute stimulation session during each crossover period
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Retrieval accuracy is assessed using a computerized object-scene associative memory task programmed in E-Prime 3.0.
Accuracy is calculated as the number of correct match/non-match responses divided by the total number of valid retrieval trials and multiplied by 100.
The reported outcome is the post-intervention value minus the pre-intervention value within each stimulation period.
Higher percentages indicate better associative memory retrieval performance.
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Immediately before and after each 20-minute stimulation session during each crossover period
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Change From Pre-intervention in Object-Scene Associative Memory Retrieval Reaction Time After Stimulation
Ramy czasowe: Immediately before and after each 20-minute stimulation session during each crossover period
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Reaction time is recorded by E-Prime 3.0 during the retrieval phase of the computerized object-scene associative memory task.
The measure is the mean reaction time across valid trials with correct responses.
Trials with no response, reaction times shorter than 300 milliseconds, or reaction times more than 3 standard deviations above the participant-specific mean are excluded according to the prespecified data-cleaning procedure.
The reported outcome is the post-intervention value minus the pre-intervention value within each stimulation period.
Shorter reaction times indicate greater retrieval efficiency.
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Immediately before and after each 20-minute stimulation session during each crossover period
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change From Pre-intervention in Left Hippocampal Task-Evoked BOLD Signal During Associative Memory Retrieval
Ramy czasowe: Before and after each 20-minute stimulation session during each crossover period, with post-intervention scanning initiated immediately after stimulation
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Task-state functional magnetic resonance imaging is acquired while participants perform the object-scene associative memory task.
The measure is the mean blood-oxygen-level-dependent (BOLD) percent signal change within a prespecified anatomically defined left hippocampal region of interest during correct associative memory retrieval relative to the task control condition.
The reported outcome is the post-intervention value minus the pre-intervention value within each stimulation period.
Positive values indicate increased retrieval-related activation of the left hippocampus.
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Before and after each 20-minute stimulation session during each crossover period, with post-intervention scanning initiated immediately after stimulation
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Change From Pre-intervention in Dual-Task Cost of 3-Meter Timed Up and Go Completion Time After Stimulation
Ramy czasowe: Immediately before and after each 20-minute stimulation session during each crossover period
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Participants perform the 3-meter Timed Up and Go test under single-task and dual-task conditions.
During the dual-task condition, participants complete the test while continuously subtracting 3 from a randomly selected three-digit number.
Total completion time is measured in seconds using the Mobility Lab wearable motion analysis system.
Each condition is tested three times, and the mean completion time is used.
Dual-task cost is calculated as: [(dual-task completion time - single-task completion time) / single-task completion time] × 100%.
The reported outcome is the post-intervention value minus the pre-intervention value within each stimulation period.
A higher dual-task cost indicates greater deterioration in mobility performance under cognitive load.
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Immediately before and after each 20-minute stimulation session during each crossover period
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Change From Pre-intervention in Dual-Task Cost of 7-Meter Walking Speed After Stimulation
Ramy czasowe: Immediately before and after each 20-minute stimulation session during each crossover period
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Participants complete the 7-meter walking test at their usual comfortable speed under single-task and dual-task conditions.
During the dual-task condition, participants walk while continuously subtracting 3 from a randomly selected three-digit number.
Walking speed is measured in meters per second using the Mobility Lab wearable motion analysis system.
Each condition is tested three times, and the mean walking speed is used.
Dual-task cost is calculated as: [(single-task walking speed - dual-task walking speed) / single-task walking speed] × 100%.
The reported outcome is the post-intervention value minus the pre-intervention value within each stimulation period.
A higher dual-task cost indicates a greater reduction in walking speed under cognitive load.
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Immediately before and after each 20-minute stimulation session during each crossover period
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Number of Participants With Any Stimulation-Associated Adverse Symptom
Ramy czasowe: During and immediately after each 20-minute stimulation session in each crossover period
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Safety is assessed using a standardized adverse-reaction questionnaire completed immediately after each stimulation session.
Prespecified symptoms include tingling, itching, burning sensation, pain, skin redness, fatigue, visual sensations, difficulty concentrating, and mood changes.
Each symptom is rated as none, mild, moderate, or severe, corresponding to scores of 0, 1, 2, and 3, respectively.
Other spontaneously reported symptoms are also recorded.
For each stimulation condition, a participant is counted as having an adverse symptom if at least one prespecified or spontaneously reported symptom is present with a severity score of 1 or higher during or immediately after stimulation.
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During and immediately after each 20-minute stimulation session in each crossover period
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Współpracownicy i badacze
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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 (Rzeczywisty)
30 lipca 2026
Zakończenie podstawowe (Szacowany)
15 lipca 2027
Ukończenie studiów (Szacowany)
30 lipca 2027
Daty rejestracji na studia
Pierwszy przesłany
8 sierpnia 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
13 sierpnia 2026
Pierwszy wysłany (Rzeczywisty)
18 sierpnia 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
18 sierpnia 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
13 sierpnia 2026
Ostatnia weryfikacja
1 sierpnia 2026
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- ID: 102772026RT090
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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