Mild Cognitive Impairment (MCI)NCT07799584
Temporal Interference Stimulation Combined With Tai Chi for Mild Cognitive Impairment
A study testing Active Transcranial Temporal Interference Stimulation and Tai Chi Training in people with Mild Cognitive Impairment (MCI), run by Shanghai University of Sport at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- What is being tested?
- Active Transcranial Temporal Interference Stimulation and Tai Chi Training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2026to 25 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60-80 years
- Community-dwelling
- Montreal Cognitive Assessment (MoCA) score < 26
- Clinical Dementia Rating (CDR) score = 0.5
- Activities of Daily Living (ADL) score < 26 (largely intact daily function)
- Does not meet criteria for dementia diagnosis (based on DSM-5 or NIA-AA criteria)
- No contraindications for MRI examination (no metallic implants, no claustrophobia)
- Able to provide written informed consent
Who cannot join
- Neurological conditions that may cause cognitive decline (e.g., cerebrovascular disease, encephalitis, Parkinson's disease, Huntington's disease)
- Severe visual, auditory, or language impairments preventing completion of neuropsychological assessments
- Severe depression (Geriatric Depression Scale > 10) or other major psychiatric disorders
- History of seizures or epilepsy
- Previous deep brain stimulation or electroconvulsive therapy within 6 months
- Alcohol or substance dependence
- Concurrent participation in another interventional clinical trial
- Contraindications for non-invasive brain stimulation: electronic or ferromagnetic implants, non-MRI compatible metal implants, history of seizures, pregnancy
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
Zhen Xu, +86 135 0590 5809, 2512516017@sus.edu.cn
About this study
Official title: Effects of Transcranial Temporal Interference Stimulation Combined With Tai Chi Training on Cognitive Function, Dual-Task Performance, and Neuroimaging Mechanisms in Individuals With Mild Cognitive Impairment
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.
Read the detailed description
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.
- Conditions
- Mild Cognitive Impairment (MCI)
- Being tested
- Active Transcranial Temporal Interference Stimulation, Placebo Transcranial Temporal Interference Stimulation, Tai Chi Training
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Transcranial Temporal Interference StimulationDevice
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 Transcranial Temporal Interference StimulationDevice
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.
Tai Chi TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Active tTIS Combined With Tai Chi | Experimental | 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. Receives: Device: Active Transcranial Temporal Interference Stimulation; Behavioral: Tai Chi Training |
| Placebo tTIS Combined With Tai Chi | Experimental | 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. Receives: Device: Placebo Transcranial Temporal Interference Stimulation; Behavioral: Tai Chi Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 8
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Throughout the 8-week intervention period and at the Week 24 follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start25 Aug 2026 (estimated)
- Primary completion25 Jul 2027 (estimated)
- Study completion25 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Sport
- Sponsor type
- University, hospital or other
- Collaborators
- Huashan Hospital
- Responsible party
- Principal investigator, Weijie Fu, Ph.D., Shanghai University of Sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799584
- Sponsor's protocol ID
- 102772026RT012
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Temporal Interference Stimulation Combined With Tai Chi Training on Cognitive Function, Dual-Task Performance, and Neuroimaging Mechanisms in Individuals With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT07799584
- Acronym / sponsor ID
- 102772026RT012
- Conditions
- Mild Cognitive Impairment (MCI)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai University of SportUniversity, hospital or other
- Collaborators
- Huashan Hospital
- Study start
- 25 Aug 2026 (estimated)
- Primary completion
- 25 Jul 2027 (estimated)
- Study completion
- 25 Jul 2027 (estimated)
- First posted
- 2 Sep 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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tTIS Combined With Tai Chi | Experimental | Device: Active Transcranial Temporal Interference Stimulation, Behavioral: Tai Chi TrainingParticipants 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. |
| Placebo tTIS Combined With Tai Chi | Experimental | Device: Placebo Transcranial Temporal Interference Stimulation, Behavioral: Tai Chi TrainingParticipants 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. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 60-80 years
- Community-dwelling
- Montreal Cognitive Assessment (MoCA) score < 26
- Clinical Dementia Rating (CDR) score = 0.5
- Activities of Daily Living (ADL) score < 26 (largely intact daily function)
Key exclusion criteria (8 listed)
- Neurological conditions that may cause cognitive decline (e.g., cerebrovascular disease, encephalitis, Parkinson's disease, Huntington's disease)
- Severe visual, auditory, or language impairments preventing completion of neuropsychological assessments
- Severe depression (Geriatric Depression Scale > 10) or other major psychiatric disorders
- History of seizures or epilepsy
- Previous deep brain stimulation or electroconvulsive therapy within 6 months
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 |
|---|---|---|
| Active Transcranial Temporal Interference StimulationActive 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. | Device | Active tTIS Combined With Tai Chi |
| Placebo Transcranial Temporal Interference StimulationPlacebo 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. | Device | Placebo tTIS Combined With Tai Chi |
| Tai Chi TrainingParticipants 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. | Behavioural | Active tTIS Combined With Tai Chi, Placebo tTIS Combined With Tai Chi |
Primary outcome
Change in Montreal Cognitive Assessment (MoCA) Score
Time frame: Baseline, Week 8, and Week 24
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.
Change in Mini-Mental State Examination (MMSE) Score
Time frame: Baseline, Week 8, and Week 24
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.
Change in Go/No-Go Task Accuracy
Time frame: Baseline, Week 8
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.
Change in Go/No-Go Task Reaction Time
Time frame: Baseline and Week 8
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.
Change in n-back Task Accuracy
Time frame: Baseline, Week 8
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.
Change in n-back Task Reaction Time
Time frame: Baseline, Week 8
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.
Change in Digit Span Forward Score
Time frame: Baseline and Week 8
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.
Change in Digit Span Backward Score
Time frame: Baseline and Week 8
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.
Change in Auditory Verbal Learning Test Trial 1 Recall
Time frame: Baseline, Week 8, and Week 24
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.
Change in Auditory Verbal Learning Test Trial 2 Recall
Time frame: Baseline, Week 8, and Week 24
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.
Change in Auditory Verbal Learning Test Trial 3 Recall
Time frame: Baseline, Week 8, and Week 24
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.
Change in Auditory Verbal Learning Test Trial 4 Recall
Time frame: Baseline, Week 8, and Week 24
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.
Change in Auditory Verbal Learning Test Trial 5 Recall
Time frame: Baseline, Week 8, and Week 24
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.
Change in Auditory Verbal Learning Test Recognition Correct Responses
Time frame: Baseline, Week 8, and Week 24
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.
Change in Auditory Verbal Learning Test Recognition Errors
Time frame: Baseline, Week 8, and Week 24
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.
Change in Face-Name Matching Task Accuracy
Time frame: Baseline, Week 8, and Week 24
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.
Change in Face-Name Matching Task Reaction Time
Time frame: Baseline, Week 8, and Week 24
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.
Change in Mnemonic Similarity Task Accuracy
Time frame: Baseline, Week 8, and Week 24
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.
Change in Mnemonic Similarity Task Reaction Time
Time frame: Baseline, Week 8, and Week 24
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.
Change in Single-Task Timed Up and Go Completion Time
Time frame: Baseline and Week 8
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.
Change in Dual-Task Timed Up and Go Completion Time
Time frame: Baseline and Week 8
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.
Change in Timed Up and Go Dual-Task Cost
Time frame: Baseline and Week 8
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.
Change in Single-Task Gait Speed
Time frame: Baseline and Week 8
Gait speed under single-task walking conditions will be recorded in meters per second (m/s). Higher gait speed indicates faster walking performance.
Change in Dual-Task Gait Speed
Time frame: Baseline and Week 8
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.
Change in Single-Task Gait Cadence
Time frame: Baseline and Week 8
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.
Change in Dual-Task Gait Cadence
Time frame: Baseline and Week 8
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.
Change in Single-Task Stride Length
Time frame: Baseline and Week 8
Stride length under single-task walking conditions will be recorded in meters (m). Greater values indicate longer stride length.
Change in Dual-Task Stride Length
Time frame: Baseline and Week 8
Stride length during cognitive-motor dual-task walking will be recorded in meters (m). Greater values indicate longer stride length during dual-tasking.
Change in Brain Structure and Function Assessed by Magnetic Resonance Imaging
Time frame: Baseline, Week 8
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.
Change in Brain Structure and Function Assessed by Magnetic Resonance Imaging
Time frame: Baseline and Week 8
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.
13 secondary outcomes
Change in Hamilton Anxiety Rating Scale Score
Time frame: Baseline, Week 8, and Week 24
Change in 17-Item Hamilton Depression Rating Scale Score
Time frame: Baseline, Week 8, and Week 24
Change in 15-Item Geriatric Depression Scale Score
Time frame: Baseline, Week 8, and Week 24
Change in Pittsburgh Sleep Quality Index Score
Time frame: Baseline, Week 8, and Week 24
Change in Epworth Sleepiness Scale Score
Time frame: Baseline, Week 8, and Week 24
Change in REM Sleep Behavior Disorder Screening Questionnaire Score
Time frame: Baseline, Week 8, and Week 24
Change in Functional Activities Questionnaire Score
Time frame: Baseline, Week 8, and Week 24
Change in 12-Item Short Form Health Survey Physical Component Summary Score
Time frame: Baseline, Week 8, and Week 24
Change in Go/No-Go Task-Evoked Oxygenated Hemoglobin Response Assessed by fNIRS
Time frame: Baseline and Week 8
Change in n-back Task-Evoked Oxygenated Hemoglobin Response Assessed by fNIRS
Time frame: Baseline and Week 8
Change in Mnemonic Similarity Task-Evoked Oxygenated Hemoglobin Response Assessed by fNIRS
Time frame: Baseline and Week 8
Blinding Effectiveness
Time frame: During the 8-week intervention period
Incidence and Severity of Adverse Events and Tolerability
Time frame: Throughout the 8-week intervention period and at the Week 24 follow-up
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 2 Sep 2026.
- Individual participant dataSharing planned: 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.
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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 Active Transcranial Temporal Interference Stimulation and Tai Chi Training 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?
The sponsor lists 8 inclusion and 8 exclusion criteria. 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 2 Sep 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. 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 Zhen Xu (+86 135 0590 5809, 2512516017@sus.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Montreal Cognitive Assessment (MoCA) Score (time frame: Baseline, Week 8, and Week 24). The study lists 30 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 2 Sep 2026.