Brain Stimulation Through the Scalp for People With Memory and Thinking Problems
Tests temporal interference stimulation against sham stimulation in people with cognitive impairment.
Plain-language title generated from the registry record
Registry title: Temporal Interference Stimulation Treatment in Patients With Cognitive Impairment
Key facts
- Where
- Tianjin, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 45 to 85 with Alzheimer's disease or frontotemporal dementia and a reliable caregiver. It tests a non-invasive brain stimulation against a sham treatment.
- Age
- 45 to 85 years
- Sex
- All sexes can join.
- Disease stage
- Probable Alzheimer's disease or mild cognitive impairment due to Alzheimer's disease, or probable behavioural variant frontotemporal dementia or primary progressive aphasia. Clinical Dementia Rating score of 1 or 2. MMSE score of 11 or more.
- Earlier treatment
- For Alzheimer's disease, standard drugs (acetylcholinesterase inhibitors and NMDA receptor antagonists) at a stable dose for at least 12 weeks before the start. People on anti-amyloid antibodies (such as lecanemab or donanemab) now or recently cannot join.
- Biomarker or test result
- For Alzheimer's disease: a positive amyloid test (amyloid PET or CSF tTau/Aβ 42) and a positive tau test (tau-PET or CSF pTau181). Genetic confirmation of FTD-related mutations is optional.
Main reasons for not taking part
- Other types of dementia or major brain disorders such as stroke, epilepsy or Parkinson's disease dementia
- Severe depression or anxiety or other major psychiatric disorders
- Metal implants that do not work with MRI or the stimulation, such as pacemakers
- Skull defects or cranial abnormalities
- Treatment with anti-amyloid antibodies, such as lecanemab or donanemab
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 45 and 85 years old?
Source: NCT07643363, who can take part
Where in China
- Tianjin Huanhu HospitalTianjin, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tianjin Huanhu Hospital
- Trial code
- NCT07643363
- Record updated
- 11 June 2026
- Original description
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.Read full original descriptionShow less
A Randomized, Sham-Controlled Trial of Temporal Interference Stimulation Treatment in Patients With Cognitive Impairment
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.
Inclusion: 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: 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); Current or recent treatment with anti-amyloid monoclonal antibodies (e.g., lecanemab, donanemab); 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); Severe visual or hearing impairment preventing task performance; History of alcohol or drug abuse; Skull defects or cranial abnormalities; Inability to tolerate EEG or head stabilization; Participation in another clinical trial within the past 3 months.