Hippocampal Temporal Interference Stimulation for Memory and Dual-Task Postural Control in Older Adults With Mild Cognitive Impairment
13 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
21
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: Jiaojiao Lü, PhD
- Número de teléfono: +86 18516565889
- Correo electrónico: ljj27@163.com
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:
- Ethics Committee of the Shanghai University of Sport
- Número de teléfono: +86 21 65508179
- Correo electrónico: lunli@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 Mayor
Acepta Voluntarios Saludables
No
Descripción
- 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 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 cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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.
Otros nombres:
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Comparador falso: 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.
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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.
Otros nombres:
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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 From Pre-intervention in Object-Scene Associative Memory Retrieval Accuracy After Stimulation
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change From Pre-intervention in Left Hippocampal Task-Evoked BOLD Signal During Associative Memory Retrieval
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 (Actual)
30 de julio de 2026
Finalización primaria (Estimado)
15 de julio de 2027
Finalización del estudio (Estimado)
30 de julio de 2027
Fechas de registro del estudio
Enviado por primera vez
8 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
13 de agosto de 2026
Publicado por primera vez (Actual)
18 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
13 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ID: 102772026RT090
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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
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