Temporal Interference Stimulation Treatment in Patients With Cognitive Impairment (NCT07643363) | Clinical Trial Compass
RecruitingNot Applicable
Temporal Interference Stimulation Treatment in Patients With Cognitive Impairment
China60 participantsStarted 2026-07-01
Plain-language summary
This study aims to evaluate the efficacy and safety of temporal interference stimulation (TIS), a non-invasive neuromodulation technique, in improving cognitive function in patients with cognitive impairment. TIS uses two high-frequency currents applied transcranially, which intersect within the brain to generate a low-frequency modulation field. This technique selectively modulates deep brain regions while minimizing the stimulation of superficial cortical layers.
Participants will undergo individualized MRI-based modeling to determine the optimal electrode placement and stimulation parameters. The intervention consists of 10 stimulation sessions over a period of 14 days, using either active TIS or sham stimulation. Cognitive assessments, EEG recordings, and functional MRI scans will be conducted at baseline; 5 days after intervention initiation; at the end of the 10-day intervention; and during follow-up assessments at 4 weeks, 8 weeks, and 12 weeks post-intervention to evaluate both immediate and long-term effects on cognitive performance and neural activity.
The study aims to determine whether TIS can serve as a feasible and effective neuromodulation strategy for individuals with cognitive impairment.
Who can participate
Age range
45 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* meets the criteria for probable AD and MCI due to AD as defined by the 2024 National Institute on Aging-Alzheimer's Association (NIA-AA) guidelines;
* Positive amyloid biomarker (amyloid PET or CSF tTau/Aβ 42);
* Positive tau biomarker (tau-PET or CSF pTau181);
* AD-related standard treatments (acetyl cholinesterase inhibitors and N-methyl-D-aspartate receptor antagonists) taken at a stable dose for at least 12 weeks prior to baseline.
* meets the criteria for probable bvFTD as defined by the revised diagnostic criteria for the behavioural variant of frontotemporal dementia (2011), or PPA as defined by the Classification of primary progressive aphasia and its variants (2011);
* Optional genetic confirmation of FTD-related pathogenic mutations (if available).
* Aged between 45 and 85 years, inclusive; no gender limitation.
* Right-handed.
* Education level ≥ 3 years.
* Mini-Mental State Examination (MMSE) score ≥ 11.
* Clinical Dementia Rating (CDR) score of 1 or 2.
* with a reliable caregiver
* Able to cooperate with cognitive assessments and cognitive training procedures.
* Full understanding of the study, voluntary participation, and provision of written informed consent approved by the Ethics Committee.
Exclusion Criteria:
* Diagnosis of other types of dementia or major neurological disorders (e.g., stroke, epilepsy, Lewy body dementia, vascular dementia, Parkinson's disease dementia, Huntington's disease).
* Major psychiatric disorders such as sev…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses something called Temporal Interference Stimulation — a brain stimulation technique I'm not familiar with — so could you explain how it works and what the procedure would actually feel like during a session?
2The trial is enrolling people with conditions ranging from mild cognitive impairment to Alzheimer's disease to FTD, so how would you determine whether my specific diagnosis and stage would be a reasonable fit to even discuss with the research team?
3Since this trial is listed as Phase NA, which I understand may mean it's an early or exploratory study, what does that tell us about how much safety and effectiveness data already exists for this type of stimulation in people with memory problems?
4The main thing they're measuring is performance on the ADAS-Cog scale — a cognitive test — so even if my scores improved on that test, how would we know whether that translates into real-world changes in my daily memory or functioning?
5Before considering this trial, is there a standard treatment path for my diagnosis that we should try first, or would participating in this study be compatible with other care options you might recommend?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes from Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score
Timeframe: Baseline; 5 days after intervention initiation; end of the 10-day intervention; and follow-up assessments at 4 weeks, 8 weeks, and 12 weeks post-intervention.