Mild Cognitive Impairment (MCI)TIS-MCINCT07519798
Effects of Transcranial Temporal Interference Stimulation on Cognitive Function in Mild Cognitive Impairment
A study testing Active Temporal Interference Stimulation (TIS) in people with Mild Cognitive Impairment (MCI), run by Shanghai University of Sport at 1 site in China.
Trial summary
To explore the effects of transcranial temporal interference stimulation (tTIS) on cognitive function and dual-task walking performance, as well as its underlying neuroimaging mechanisms, 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 Temporal Interference Stimulation (TIS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2026to 15 Aug 2026
- 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
Shanghai University of Sport
Shanghai, Shanghai Municipality, 200438
About this study
Official title: The Effects of Transcranial Temporal Interferential Electrical Stimulation on Cognitive Function, Dual-Task Performance and Neuroplasticity in Individuals With Mild Cognitive Impairment
To explore the effects of transcranial temporal interference stimulation (tTIS) on cognitive function and dual-task walking performance, as well as its underlying neuroimaging mechanisms, in individuals with mild cognitive impairment.
Read the detailed description
This is a randomized, double-blind, sham-controlled, crossover trial. Participants aged 60-80 years with mild cognitive impairment (MoCA < 26, CDR = 0.5) will receive a single 20-minute session of individualized 5 Hz transcranial temporal interference stimulation (tTIS) targeting the left hippocampus (2 mA, 2000/2005 Hz carriers) and a sham session in random order, with a 7-day washout period. The primary outcomes are change in MoCA score, dual-task gait/balance cost, and working memory performance. Secondary outcomes include change in brain function and brain structure. The study aims to enroll 40 participants. Safety and tolerability will be assessed via structured questionnaires.
- Conditions
- Mild Cognitive Impairment (MCI)
- Being tested
- Active Temporal Interference Stimulation (TIS), Placebo / Sham 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.
Active Temporal Interference Stimulation (TIS)Device
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.
Placebo / Sham TISDevice
Sham 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.
| Study group | Role | What they receive |
|---|---|---|
| Active TIS followed by Placebo TIS | Experimental | Participants first receive single-session active TIS targeting the hippocampus for approx. 20 minutes. Following a washout period, they receive placebo (sham) TIS. Receives: Device: Active Temporal Interference Stimulation (TIS); Device: Placebo / Sham TIS |
| Placebo TIS followed by Active TIS | Experimental | Participants first receive single-session placebo (sham) TIS for approx. 20 minutes. Following a washout period, they receive active TIS targeting the hippocampus. Receives: Device: Active Temporal Interference Stimulation (TIS); Device: Placebo / Sham TIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Montreal Cognitive Assessment (MoCA) Score
Measured: Baseline and immediately after intervention
Change in Gait-Related and Balance-Related Dual-Task Cost
Measured: Baseline and immediately after intervention
Change in Working Memory Performance
Measured: Baseline and immediately after intervention
Secondary outcomes (2)
Change in Brain function
Measured: Baseline and immediately after intervention
Chang in Brain structure
Measured: Baseline and immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start15 Apr 2026 (estimated)
- Primary completion15 Aug 2026 (estimated)
- Study completion15 Aug 2026 (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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 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
- NCT07519798
- Sponsor's protocol ID
- 102772025RT208
- Other IDs
- ChiCTR2600119709
- Acronym
- TIS-MCI
- Status last verified
- Apr 2026
- First submitted
- 27 Mar 2026
- Last updated
- 9 Apr 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 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Transcranial Temporal Interferential Electrical Stimulation on Cognitive Function, Dual-Task Performance and Neuroplasticity in Individuals With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT07519798
- Acronym / sponsor ID
- TIS-MCI / 102772025RT208
- Conditions
- Mild Cognitive Impairment (MCI)
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai University of SportUniversity, hospital or other
- Collaborators
- Huashan Hospital
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 9 Apr 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.
To explore the effects of transcranial temporal interference stimulation (tTIS) on cognitive function and dual-task walking performance, as well as its underlying neuroimaging mechanisms, in individuals with mild cognitive impairment.
Detailed description
This is a randomized, double-blind, sham-controlled, crossover trial. Participants aged 60-80 years with mild cognitive impairment (MoCA < 26, CDR = 0.5) will receive a single 20-minute session of individualized 5 Hz transcranial temporal interference stimulation (tTIS) targeting the left hippocampus (2 mA, 2000/2005 Hz carriers) and a sham session in random order, with a 7-day washout period. The primary outcomes are change in MoCA score, dual-task gait/balance cost, and working memory performance. Secondary outcomes include change in brain function and brain structure. The study aims to enroll 40 participants. Safety and tolerability will be assessed via structured questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active TIS followed by Placebo TIS | Experimental | Device: Active Temporal Interference Stimulation (TIS), Device: Placebo / Sham TISParticipants first receive single-session active TIS targeting the hippocampus for approx. 20 minutes. Following a washout period, they receive placebo (sham) TIS. |
| Placebo TIS followed by Active TIS | Experimental | Device: Active Temporal Interference Stimulation (TIS), Device: Placebo / Sham TISParticipants first receive single-session placebo (sham) TIS for approx. 20 minutes. Following a washout period, they receive active TIS targeting the hippocampus. |
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 Temporal Interference Stimulation (TIS)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. | Device | Active TIS followed by Placebo TIS, Placebo TIS followed by Active TIS |
| Placebo / Sham TISSham 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. | Device | Active TIS followed by Placebo TIS, Placebo TIS followed by Active TIS |
Primary outcome
Change in Montreal Cognitive Assessment (MoCA) Score
Time frame: Baseline and immediately after intervention
Change in Gait-Related and Balance-Related Dual-Task Cost
Time frame: Baseline and immediately after intervention
Change in Working Memory Performance
Time frame: Baseline and immediately after intervention
2 secondary outcomes
Change in Brain function
Time frame: Baseline and immediately after intervention
Chang in Brain structure
Time frame: Baseline and immediately after intervention
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 9 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Temporal Interference Stimulation (TIS) 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: enrolling by invitation, as of the sponsor's last update on 9 Apr 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Montreal Cognitive Assessment (MoCA) Score (time frame: Baseline and immediately after intervention). The study lists 3 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 9 Apr 2026.