An interventional study of Active Transcranial Temporal Interference Stimulation and Placebo Transcranial Temporal Interference Stimulation in Mild Cognitive Impairment (MCI), sponsored by Shanghai University of Sport. Recruiting at 1 site in China. Open to participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Shanghai University of Sport · Not applicable, Interventional, and Treatment
This study aims to evaluate whether individualized hippocampal transcranial temporal interference stimulation (tTIS) combined with Tai Chi training can improve cognitive function and dual-task performance in individuals with mild cognitive impairment. Participants will be randomly assigned to receive either active or sham individualized tTIS combined with Tai Chi training for 8 weeks. The study will also investigate changes in brain structure and function using neuroimaging and assess whether the intervention effects are maintained during follow-up.
This is a randomized, quadruple-blind, sham-controlled, parallel-group trial involving approximately 120 individuals aged 60-80 years with mild cognitive impairment. Participants will be randomly assigned to receive either active or sham individualized transcranial temporal interference stimulation (tTIS) combined with Tai Chi training for 8 weeks, three sessions per week. Individualized tTIS will target the left hippocampus based on participant-specific T1-weighted MRI and finite element modeling, using a 5-Hz interference frequency generated by 2000- and 2005-Hz carrier frequencies at an intensity of 2 mA for 20 minutes per session; each Tai Chi session will last approximately 60 minutes. Global cognition, episodic memory, neuropsychiatric symptoms, functional status, and health-related quality of life will be assessed at baseline, after the 8-week intervention, and at a 16-week post-intervention follow-up. Working memory and executive control, dual-task performance, and neuroimaging outcomes will be assessed at baseline and after the 8-week intervention, with safety, tolerability, and blinding effectiveness monitored throughout the study.
3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
This study's planned enrollment of 120 is above the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.
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Exclusion Criteria:
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.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive active individualized hippocampal transcranial temporal interference stimulation (tTIS) combined with Tai Chi training for 8 weeks, three sessions per week. Each tTIS session will last 20 minutes and each Tai Chi session approximately 60 minutes.
Device: Active Transcranial Temporal Interference Stimulation · Behavioral: Tai Chi Training
Participants will receive sham individualized hippocampal transcranial temporal interference stimulation (tTIS) combined with the same Tai Chi training for 8 weeks, three sessions per week. Placebo (sham) stimulation will use the same electrode configuration and session duration as active stimulation but without effective stimulation during the main stimulation period.
Device: Placebo Transcranial Temporal Interference Stimulation · Behavioral: Tai Chi Training
Active tTIS delivered via surface electrodes targeting the hippocampus. Parameters: 2 mA baseline-to-peak intensity, 20-minute duration with 30-second ramp-up and ramp-down. The stimulation protocol is individualized based on each participant's T1-weighted structural MRI using finite element modeling to optimize electric field distribution to the hippocampal target. Stimulation will be administered three times per week for 8 weeks.
Placebo stimulation delivered using the same electrode placement and parameters as active stimulation. To mimic the sensory experience without effective neuromodulation, active current is delivered only during the 30-second ramp-up and ramp-down periods. During the 20-minute stimulation period, no current is delivered. Participants are unable to distinguish sham from active stimulation based on sensation. Sham stimulation will be administered three times per week for 8 weeks.
Participants will receive standardized Tai Chi training for approximately 60 minutes per session, three sessions per week for 8 weeks. The same Tai Chi training protocol will be provided to participants in both study arms.
Change in Montreal Cognitive Assessment (MoCA) Score
Global cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). The total score ranges from 0 to 30, with higher scores indicating better cognitive function. Changes from baseline will be evaluated after the intervention and at follow-up.
Time frame: Baseline, Week 8, and Week 24
Change in Mini-Mental State Examination (MMSE) Score
Global cognitive function will also be assessed using the Mini-Mental State Examination (MMSE). The total score ranges from 0 to 30, with higher scores indicating better cognitive function. Changes from baseline will be evaluated after the intervention and at follow-up.
Time frame: Baseline, Week 8, and Week 24
Change in Go/No-Go Task Accuracy
Inhibitory control will be assessed using accuracy on the Go/No-Go task. Accuracy will be expressed as the percentage of correct responses, with higher values indicating better performance.
Time frame: Baseline, Week 8
Change in Go/No-Go Task Reaction Time
Inhibitory control will be assessed using reaction time for correct responses on the Go/No-Go task. Reaction time will be recorded in milliseconds (ms), with shorter reaction times indicating faster task performance.
Time frame: Baseline and Week 8
Change in n-back Task Accuracy
Working memory performance will be assessed using accuracy on the n-back task. Accuracy will be expressed as the percentage of correct responses, with higher values indicating better performance.
Time frame: Baseline, Week 8
Change in n-back Task Reaction Time
Working memory performance will be assessed using reaction time for correct responses on the n-back task. Reaction time will be recorded in milliseconds (ms), with shorter reaction times indicating faster task performance.
Time frame: Baseline, Week 8
Change in Digit Span Forward Score
Attention and short-term memory will be assessed using the Digit Span Forward task. Performance will be recorded as the raw Digit Span Forward score, with higher scores indicating better performance.
Time frame: Baseline and Week 8
Change in Digit Span Backward Score
Working memory will be assessed using the Digit Span Backward task. Performance will be recorded as the raw Digit Span Backward score, with higher scores indicating better performance.
Time frame: Baseline and Week 8
Change in Auditory Verbal Learning Test Trial 1 Recall
Immediate verbal memory will be assessed using the number of words correctly recalled during Trial 1 (N1) of the Auditory Verbal Learning Test (AVLT). Higher numbers of correctly recalled words indicate better memory performance.
Time frame: Baseline, Week 8, and Week 24
Change in Auditory Verbal Learning Test Trial 2 Recall
Verbal learning performance will be assessed using the number of words correctly recalled during Trial 2 (N2) of the Auditory Verbal Learning Test (AVLT). Higher numbers of correctly recalled words indicate better performance.
Time frame: Baseline, Week 8, and Week 24
Change in Auditory Verbal Learning Test Trial 3 Recall
Verbal learning performance will be assessed using the number of words correctly recalled during Trial 3 (N3) of the Auditory Verbal Learning Test (AVLT). Higher numbers of correctly recalled words indicate better performance.
Time frame: Baseline, Week 8, and Week 24
Change in Auditory Verbal Learning Test Trial 4 Recall
Verbal learning performance will be assessed using the number of words correctly recalled during Trial 4 (N4) of the Auditory Verbal Learning Test (AVLT). Higher numbers of correctly recalled words indicate better performance.
Time frame: Baseline, Week 8, and Week 24
Change in Auditory Verbal Learning Test Trial 5 Recall
Verbal learning performance will be assessed using the number of words correctly recalled during Trial 5 (N5) of the Auditory Verbal Learning Test (AVLT). Higher numbers of correctly recalled words indicate better performance.
Time frame: Baseline, Week 8, and Week 24
Change in Auditory Verbal Learning Test Recognition Correct Responses
Recognition memory will be assessed using the number of correct recognition responses on the Auditory Verbal Learning Test (AVLT). A higher number of correct recognition responses indicates better recognition memory.
Time frame: Baseline, Week 8, and Week 24
Change in Auditory Verbal Learning Test Recognition Errors
Recognition memory errors will be assessed using the number of incorrect recognition responses on the Auditory Verbal Learning Test (AVLT). A lower number of recognition errors indicates better recognition memory performance.
Time frame: Baseline, Week 8, and Week 24
Change in Face-Name Matching Task Accuracy
Associative episodic memory will be assessed using accuracy on the face-name matching task. Accuracy will be expressed as the percentage of correct responses, with higher values indicating better performance.
Time frame: Baseline, Week 8, and Week 24
Change in Face-Name Matching Task Reaction Time
Associative episodic memory performance will be assessed using reaction time for correct responses on the face-name matching task. Reaction time will be recorded in milliseconds (ms), with shorter reaction times indicating faster task performance.
Time frame: Baseline, Week 8, and Week 24
Change in Mnemonic Similarity Task Accuracy
Episodic memory and mnemonic discrimination will be assessed using accuracy on the Mnemonic Similarity Task (MST). Accuracy will be expressed as the percentage of correct responses, with higher values indicating better performance.
Time frame: Baseline, Week 8, and Week 24
Change in Mnemonic Similarity Task Reaction Time
Performance on the Mnemonic Similarity Task (MST) will also be assessed using reaction time for correct responses. Reaction time will be recorded in milliseconds (ms), with shorter reaction times indicating faster task performance.
Time frame: Baseline, Week 8, and Week 24
Change in Single-Task Timed Up and Go Completion Time
Mobility under single-task conditions will be assessed using the Timed Up and Go (TUG) test. Completion time will be recorded in seconds, with shorter completion times indicating better mobility performance.
Time frame: Baseline and Week 8
Change in Dual-Task Timed Up and Go Completion Time
Cognitive-motor dual-task performance will be assessed using the Timed Up and Go (TUG) test performed concurrently with a cognitive task. Completion time will be recorded in seconds, with shorter completion times indicating better dual-task mobility performance.
Time frame: Baseline and Week 8
Change in Timed Up and Go Dual-Task Cost
Dual-task cost for Timed Up and Go completion time will be calculated as \[(dual-task completion time - single-task completion time) / single-task completion time\] × 100%. Higher positive values indicate greater deterioration in mobility performance under dual-task conditions.
Time frame: Baseline and Week 8
Change in Single-Task Gait Speed
Gait speed under single-task walking conditions will be recorded in meters per second (m/s). Higher gait speed indicates faster walking performance.
Time frame: Baseline and Week 8
Change in Dual-Task Gait Speed
Gait speed during cognitive-motor dual-task walking will be recorded in meters per second (m/s). Higher gait speed indicates faster walking performance during dual-tasking.
Time frame: Baseline and Week 8
Change in Single-Task Gait Cadence
Gait cadence under single-task walking conditions will be recorded as steps per minute (steps/min). Higher values indicate a greater number of steps performed per minute.
Time frame: Baseline and Week 8
Change in Dual-Task Gait Cadence
Gait cadence during cognitive-motor dual-task walking will be recorded as steps per minute (steps/min). Higher values indicate a greater number of steps performed per minute during dual-tasking.
Time frame: Baseline and Week 8
Change in Single-Task Stride Length
Stride length under single-task walking conditions will be recorded in meters (m). Greater values indicate longer stride length.
Time frame: Baseline and Week 8
Change in Dual-Task Stride Length
Stride length during cognitive-motor dual-task walking will be recorded in meters (m). Greater values indicate longer stride length during dual-tasking.
Time frame: Baseline and Week 8
Change in Brain Structure and Function Assessed by Magnetic Resonance Imaging
Changes in brain structure and function will be assessed using multimodal magnetic resonance imaging (MRI). MRI-derived structural and functional measures will be used to characterize intervention-related brain changes.
Time frame: Baseline, Week 8
Change in Brain Structure and Function Assessed by Magnetic Resonance Imaging
Changes in brain structure and function will be assessed using multimodal magnetic resonance imaging (MRI). MRI-derived structural and functional measures will be used to characterize intervention-related brain changes.
Time frame: Baseline and Week 8
Change in Hamilton Anxiety Rating Scale Score
Anxiety symptoms will be assessed using the Hamilton Anxiety Rating Scale (HAM-A). The total score ranges from 0 to 56, with higher scores indicating greater anxiety symptom severity.
Time frame: Baseline, Week 8, and Week 24
Change in 17-Item Hamilton Depression Rating Scale Score
Depressive symptoms will be assessed using the 17-item Hamilton Depression Rating Scale (HAM-D-17). The total score ranges from 0 to 52, with higher scores indicating greater depressive symptom severity.
Time frame: Baseline, Week 8, and Week 24
Change in 15-Item Geriatric Depression Scale Score
Depressive symptoms will also be assessed using the 15-item Geriatric Depression Scale (GDS-15). The total score ranges from 0 to 15, with higher scores indicating greater depressive symptom severity.
Time frame: Baseline, Week 8, and Week 24
Change in Pittsburgh Sleep Quality Index Score
Subjective sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
Time frame: Baseline, Week 8, and Week 24
Change in Epworth Sleepiness Scale Score
Daytime sleepiness will be assessed using the Epworth Sleepiness Scale (ESS). The total score ranges from 0 to 24, with higher scores indicating greater daytime sleepiness.
Time frame: Baseline, Week 8, and Week 24
Change in REM Sleep Behavior Disorder Screening Questionnaire Score
Symptoms related to REM sleep behavior disorder will be assessed using the REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ). The total score ranges from 0 to 13, with higher scores indicating more symptoms suggestive of REM sleep behavior disorder.
Time frame: Baseline, Week 8, and Week 24
Change in Functional Activities Questionnaire Score
Daily functional ability will be assessed using the Functional Activities Questionnaire (FAQ). The total score ranges from 0 to 30, with higher scores indicating greater impairment in instrumental activities of daily living.
Time frame: Baseline, Week 8, and Week 24
Change in 12-Item Short Form Health Survey Physical Component Summary Score
Physical health-related quality of life will be assessed using the Physical Component Summary (PCS) score of the 12-Item Short Form Health Survey (SF-12). The PCS is a norm-based summary score, with higher scores indicating better physical health-related quality of life.
Time frame: Baseline, Week 8, and Week 24
Change in Go/No-Go Task-Evoked Oxygenated Hemoglobin Response Assessed by fNIRS
Task-evoked cerebral hemodynamic response during the Go/No-Go task will be assessed using functional near-infrared spectroscopy (fNIRS). The primary fNIRS measure will be the task-related change in oxygenated hemoglobin (HbO) concentration in predefined cortical regions.
Time frame: Baseline and Week 8
Change in n-back Task-Evoked Oxygenated Hemoglobin Response Assessed by fNIRS
Task-evoked cerebral hemodynamic response during the n-back task will be assessed using functional near-infrared spectroscopy (fNIRS). The primary fNIRS measure will be the task-related change in oxygenated hemoglobin (HbO) concentration in predefined cortical regions.
Time frame: Baseline and Week 8
Change in Mnemonic Similarity Task-Evoked Oxygenated Hemoglobin Response Assessed by fNIRS
Task-evoked cerebral hemodynamic response during the Mnemonic Similarity Task (MST) will be assessed using functional near-infrared spectroscopy (fNIRS). The primary fNIRS measure will be the task-related change in oxygenated hemoglobin (HbO) concentration in predefined cortical regions.
Time frame: Baseline and Week 8
Blinding Effectiveness
Blinding effectiveness will be assessed by asking participants to indicate whether they believe they received active or sham transcranial temporal interference stimulation. Participants' treatment guesses will be used to evaluate the success of participant blinding.
Time frame: During the 8-week intervention period
Incidence and Severity of Adverse Events and Tolerability
Adverse events and tolerability will be assessed using structured questionnaires and participant reports. The occurrence, type, and severity of stimulation-related adverse events and discomfort will be recorded, including symptoms such as tingling, itching, headache, dizziness, or other reported adverse effects.
Time frame: Throughout the 8-week intervention period and at the Week 24 follow-up
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified individual participant data for primary and secondary outcome measures will be made available upon reasonable request to the corresponding author after publication of the main results.
Time frame: Beginning 6 months after publication of the main results.
Access criteria: Data will be made available upon reasonable request to the corresponding author. Data will be shared with researchers who submit a methodologically sound research proposal and intend to use the data for non-commercial purposes. Applicants must sign a data access agreement.
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