Mild Cognitive Impairment (MCI)NCT07771036
Hippocampal Temporal Interference Stimulation for Memory and Dual-Task Postural Control in Older Adults With Mild Cognitive Impairment
A study testing Temporal Interference Stimulation in people with Mild Cognitive Impairment (MCI), run by Shanghai University of Sport at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- What is being tested?
- Temporal Interference Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2026to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai University of Sport
Shanghai, Shanghai Municipality, 200438
Ethics Committee of the Shanghai University of Sport, +86 21 65508179, lunli@sus.edu.cn
About this study
Official title: 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.
Read more
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)
- Being tested
- Temporal Interference Stimulation
- Keywords
- Mild Cognitive Impairment, Temporal Interference Stimulation, TIs
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporal Interference StimulationDevice
Also called TIs
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Temporal Interference Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Immediately before and after each 20-minute stimulation session during each crossover period
Number of Participants With Any Stimulation-Associated Adverse Symptom
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.
Measured: During and immediately after each 20-minute stimulation session in each crossover period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start30 Jul 2026
- Primary completion15 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Sport
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiaojiao Lü, PhD, Shanghai University of Sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771036
- Sponsor's protocol ID
- ID: 102772026RT090
- Status last verified
- Aug 2026
- First submitted
- 8 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07771036
- Acronym / sponsor ID
- ID: 102772026RT090
- Conditions
- Mild Cognitive Impairment (MCI)
- Keywords
- Mild Cognitive Impairment, Temporal Interference Stimulation, TIs
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Shanghai University of SportUniversity, hospital or other
- Study start
- 30 Jul 2026 (actual)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIs Arm | Experimental | Device: Temporal Interference StimulationParticipants 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. |
| sham group | Sham comparator | Device: Temporal Interference StimulationParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temporal Interference StimulationAlso: TIsTranscranial 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. | Device | TIs Arm, sham group |
Primary outcome
Change From Pre-intervention in Object-Scene Associative Memory Retrieval Accuracy After Stimulation
Time frame: 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.
Change From Pre-intervention in Object-Scene Associative Memory Retrieval Reaction Time After Stimulation
Time frame: 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.
4 secondary outcomes
Change From Pre-intervention in Left Hippocampal Task-Evoked BOLD Signal During Associative Memory Retrieval
Time frame: 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
Time frame: 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
Time frame: Immediately before and after each 20-minute stimulation session during each crossover period
Number of Participants With Any Stimulation-Associated Adverse Symptom
Time frame: During and immediately after each 20-minute stimulation session in each crossover period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporal Interference Stimulation in people with Mild Cognitive Impairment (MCI), run by Shanghai University of Sport at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiaojiao Lü, PhD (+86 18516565889, ljj27@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Pre-intervention in Object-Scene Associative Memory Retrieval Accuracy After Stimulation (time frame: Immediately before and after each 20-minute stimulation session during each crossover period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.