NCT07643363 · RECRUITING
Temporal Interference Stimulation Treatment in Patients With Cognitive Impairment
This trial tests whether temporal interference stimulation, a non-invasive way of using electrical currents to reach deep brain areas, can improve thinking skills in people with cognitive impairment. Participants get 10 sessions of real or sham stimulation, plus cognitive training. It is an early device study with no phase assigned, not yet proven or approved.
You may qualify if
- 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.
You're excluded if
- 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 severe depression or anxiety.
- Severe systemic or organ dysfunction (e.g., heart failure III-IV, liver cirrhosis, renal failure).
- Use of medications that significantly affect cognition (e.g., anticholinergics, sedatives), unless approved by the physician.
- Presence of metal implants incompatible with MRI or TIS (e.g., pacemakers, deep brain stimulators).
- Skull defects or cranial abnormalities.
- Inability to tolerate EEG or head stabilization.
- Severe visual or hearing impairment preventing task performance.
- History of alcohol or drug abuse.
- Participation in another clinical trial within the past 3 months.
- Current or recent treatment with anti-amyloid monoclonal antibodies (e.g., lecanemab, donanemab).
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-06-11