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

13. august 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

21

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Jiaojiao Lü, PhD
  • Telefonnummer: +86 18516565889
  • E-post: ljj27@163.com

Studiesteder

  • Kina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200438
        • Rekruttering
        • Shanghai University of Sport
        • Ta kontakt med:
          • Ethics Committee of the Shanghai University of Sport
          • Telefonnummer: +86 21 65508179
          • E-post: lunli@sus.edu.cn

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

  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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: 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.
Andre navn:
  • TIs
Sham-komparator: 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.
Enhet: 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.
Andre navn:
  • TIs

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Pre-intervention in Object-Scene Associative Memory Retrieval Accuracy After Stimulation
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Pre-intervention in Left Hippocampal Task-Evoked BOLD Signal During Associative Memory Retrieval
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Shanghai University of Sport

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

30. juli 2026

Primær fullføring (Antatt)

15. juli 2027

Studiet fullført (Antatt)

30. juli 2027

Datoer for studieregistrering

Først innsendt

8. august 2026

Først innsendt som oppfylte QC-kriteriene

13. august 2026

Først lagt ut (Faktiske)

18. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ID: 102772026RT090

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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