An interventional study of Temporal Interference Stimulation in Mild Cognitive Impairment (MCI), sponsored by Shanghai University of Sport. Recruiting at 1 site in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Shanghai University of Sport · Not applicable, Interventional, and Treatment
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:
Participants will be required to:
3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
This study's planned enrollment of 21 is below the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Shanghai University of Sport is the lead sponsor of 21 studies on the registry; 7 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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.
Time frame: 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.
Time frame: Immediately before and after each 20-minute stimulation session during each crossover period
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.
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
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.
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
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.
Time frame: 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.
Time frame: During and immediately after each 20-minute stimulation session in each crossover period
Plan to share: No
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Shanghai University of Sport