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Hippocampal Temporal Interference Stimulation for Memory and Dual-Task Postural Control in Older Adults With Mild Cognitive Impairment

13 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

21

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Jiaojiao Lü, PhD
  • Telefoonnummer: +86 18516565889
  • E-mail: ljj27@163.com

Studie Locaties

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200438
        • Werving
        • Shanghai University of Sport
        • Contact:
          • Ethics Committee of the Shanghai University of Sport
          • Telefoonnummer: +86 21 65508179
          • E-mail: lunli@sus.edu.cn

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

  1. Aged 65 years or older;
  2. Presence of subjective memory complaints;
  3. 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;
  4. Clinical Dementia Rating (CDR) score of 0.5;
  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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Apparaat: Temporal Interference Stimulation
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.
Andere namen:
  • TIs
Sham-vergelijker: 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.
Apparaat: Temporal Interference Stimulation
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.
Andere namen:
  • TIs

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Pre-intervention in Object-Scene Associative Memory Retrieval Accuracy After Stimulation
Tijdsspanne: Immediately before and after each 20-minute stimulation session during each crossover period
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.
Immediately before and after each 20-minute stimulation session during each crossover period
Change From Pre-intervention in Object-Scene Associative Memory Retrieval Reaction Time After Stimulation
Tijdsspanne: Immediately before and after each 20-minute stimulation session during each crossover period
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.
Immediately before and after each 20-minute stimulation session during each crossover period

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Pre-intervention in Left Hippocampal Task-Evoked BOLD Signal During Associative Memory Retrieval
Tijdsspanne: Before and after each 20-minute stimulation session during each crossover period, with post-intervention scanning initiated immediately after stimulation
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.
Before and after each 20-minute stimulation session during each crossover period, with post-intervention scanning initiated immediately after stimulation
Change From Pre-intervention in Dual-Task Cost of 3-Meter Timed Up and Go Completion Time After Stimulation
Tijdsspanne: Immediately before and after each 20-minute stimulation session during each crossover period
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.
Immediately before and after each 20-minute stimulation session during each crossover period
Change From Pre-intervention in Dual-Task Cost of 7-Meter Walking Speed After Stimulation
Tijdsspanne: Immediately before and after each 20-minute stimulation session during each crossover period
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.
Immediately before and after each 20-minute stimulation session during each crossover period
Number of Participants With Any Stimulation-Associated Adverse Symptom
Tijdsspanne: During and immediately after each 20-minute stimulation session in each crossover period
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.
During and immediately after each 20-minute stimulation session in each crossover period

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Shanghai University of Sport

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

30 juli 2026

Primaire voltooiing (Geschat)

15 juli 2027

Studie voltooiing (Geschat)

30 juli 2027

Studieregistratiedata

Eerst ingediend

8 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

13 augustus 2026

Eerst geplaatst (Werkelijk)

18 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

18 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

13 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ID: 102772026RT090

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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