Hippocampal Temporal Interference Stimulation for Memory and Dual-Task Postural Control in Older Adults With Mild Cognitive Impairment
2026年8月13日 更新者：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.
研究概览
研究类型
介入性
注册 (估计的)
21
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Jiaojiao Lü, PhD
- 电话号码：+86 18516565889
- 邮箱：ljj27@163.com
学习地点
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200438
- 招聘中
- Shanghai University of Sport
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接触：
- Ethics Committee of the Shanghai University of Sport
- 电话号码：+86 21 65508179
- 邮箱：lunli@sus.edu.cn
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 年长者
接受健康志愿者
不
描述
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：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.
其他名称：
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假比较器：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.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change From Pre-intervention in Object-Scene Associative Memory Retrieval Accuracy After Stimulation
大体时间：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
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Change From Pre-intervention in Left Hippocampal Task-Evoked BOLD Signal During Associative Memory Retrieval
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年7月30日
初级完成 (估计的)
2027年7月15日
研究完成 (估计的)
2027年7月30日
研究注册日期
首次提交
2026年8月8日
首先提交符合 QC 标准的
2026年8月13日
首次发布 (实际的)
2026年8月18日
研究记录更新
最后更新发布 (实际的)
2026年8月18日
上次提交的符合 QC 标准的更新
2026年8月13日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.