Hippocampal Temporal Interference Stimulation for Memory and Dual-Task Postural Control in Older Adults With Mild Cognitive Impairment
13 de agosto de 2026 atualizado 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.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
21
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Jiaojiao Lü, PhD
- Número de telefone: +86 18516565889
- E-mail: ljj27@163.com
Locais de estudo
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200438
- Recrutamento
- Shanghai University of Sport
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Contato:
- Ethics Committee of the Shanghai University of Sport
- Número de telefone: +86 21 65508179
- E-mail: lunli@sus.edu.cn
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
- 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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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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.
Outros nomes:
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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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change From Pre-intervention in Object-Scene Associative Memory Retrieval Accuracy After Stimulation
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Change From Pre-intervention in Left Hippocampal Task-Evoked BOLD Signal During Associative Memory Retrieval
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
30 de julho de 2026
Conclusão Primária (Estimado)
15 de julho de 2027
Conclusão do estudo (Estimado)
30 de julho de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
8 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
13 de agosto de 2026
Primeira postagem (Real)
18 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
18 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
13 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ID: 102772026RT090
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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