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.
調査の概要
研究の種類
介入
入学 (推定)
21
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Jiaojiao Lü, PhD
- 電話番号：+86 18516565889
- メール：ljj27@163.com
研究場所
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200438
- 募集
- Shanghai University of Sport
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コンタクト：
- Ethics Committee of the Shanghai University of Sport
- 電話番号：+86 21 65508179
- メール：lunli@sus.edu.cn
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
- 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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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.
他の名前：
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偽コンパレータ：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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Pre-intervention in Object-Scene Associative Memory Retrieval Accuracy After Stimulation
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Pre-intervention in Left Hippocampal Task-Evoked BOLD Signal During Associative Memory Retrieval
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年7月30日
一次修了 (推定)
2027年7月15日
研究の完了 (推定)
2027年7月30日
試験登録日
最初に提出
2026年8月8日
QC基準を満たした最初の提出物
2026年8月13日
最初の投稿 (実際)
2026年8月18日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月18日
QC基準を満たした最後の更新が送信されました
2026年8月13日
最終確認日
2026年8月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。