Temporal Interference Stimulation for cognitive impairment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the safety and potential cognitive benefits of temporal interference stimulation (TIS) delivered via individualized electrode placement based on MRI modeling. Participants will undergo 10 stimulation sessions over 14 days, receiving either active TIS or sham stimulation, with cognitive tests, EEG, and MRI assessments at multiple time points. The study includes people with amnestic MCI, AD with MCI, Alzheimer's dementia, and frontotemporal dementia, and incorporates existing AD- and FTD-related treatments. Outcomes will be tracked at baseline, during the intervention, and up to 12 weeks post-treatment to assess durability of any effects. Additional cognitive training components may be explored alongside TIS.

Why it matters

Who can join: the full rules

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 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).

Where it's running

• Tianjin Huanhu Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Mou Zhehui
• Email: muzhehui@gmail.com
• Phone: +86 18959257015

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.