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

NCT07771036 | Recruiting

• 1 other identifier: ID: 102772026RT090
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mild Cognitive Impairment (MCI)

Keywords

Mild Cognitive Impairment; Temporal Interference Stimulation; TIs

Outcome Measures

Primary Outcomes (2)

• Change From Pre-intervention in Object-Scene Associative Memory Retrieval Accuracy After Stimulation

  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

  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

Secondary Outcomes (4)

• Change From Pre-intervention in Left Hippocampal Task-Evoked BOLD Signal During Associative Memory Retrieval

  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

  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

  Immediately before and after each 20-minute stimulation session during each crossover period

• Number of Participants With Any Stimulation-Associated Adverse Symptom

  During and immediately after each 20-minute stimulation session in each crossover period

Study Arms (2)

TIs Arm

EXPERIMENTAL

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.

Device: Temporal Interference Stimulation

sham group

SHAM COMPARATOR

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.

Device: Temporal Interference Stimulation

Interventions

Temporal Interference Stimulation DEVICE

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.

Also known as: TIs

TIs Arm; sham group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Shanghai University of Sport: lead

Study Sites (1)

Shanghai University of Sport

Shanghai, Shanghai Municipality, 200438, China

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Jiaojiao Lü, PhD

CONTACT

+86 18516565889; ljj27@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Shanghai University of Sport

Study Record Dates

• First Submitted: August 8, 2026
• First Posted: August 18, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: August 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)