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A Randomized Controlled Clinical Trial of Temporal Interference Stimulation at Different Frequencies for the Treatment of Alzheimer's Disease

Development of Key Technologies and a System for Assessment, Early Warning, and Multi-Physical Factor Collaborative Stimulation Intervention for Age-Related Consciousness/Cognitive Impairment——A Randomized Controlled Clinical Trial of Temporal Interference Stimulation at Different Frequencies for the Treatment of Alzheimer's Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123882
Enrollment
Unknown
Registered
2026-04-30
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Interventions

TIS-? group:Temporal interference stimulation (TIS) will be delivered to the anterior part of the left hippocampus using carrier frequencies of 2000 Hz and 2005 Hz, producing a 5 Hz envelope frequency
TIS-? group:Temporal interference stimulation (TIS) will be delivered to the anterior part of the left hippocampus using carrier frequencies of 2000 Hz and 2040 Hz, producing a 40 Hz envelope frequenc
TIS-sham group:Temporal interference stimulation (TIS) will be delivered to the anterior part of the left hippocampus using carrier frequencies of 2000 Hz and 2000 Hz, producing a 0 Hz envelope freque

Sponsors

The Third Affiliated Hospital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Aged >=50 years at the time of voluntary participation and signing of the informed consent form. 2. Subject or informant reports progressive and gradual changes in memory function for >=3 months. 3. Diagnosed with Alzheimer's disease (AD) according to the National Institute on Aging–Alzheimer's Association (NIA-AA) 2024 diagnostic criteria. 4. Presence of mild cognitive impairment or mild-to-moderate dementia (10 <= MMSE <= 30 and CDR-GS = 0.5–2). 5. Sufficient literacy, auditory and visual abilities to complete neuropsychological testing. 6. If using cognitive-enhancing medications (e.g., donepezil, memantine), the dose must have been stable for at least 3 months prior to enrollment, and no dose adjustments will be made during the study period.

Exclusion criteria

Exclusion criteria: 1. Prior history of neurological disorders including brain tumor, traumatic brain injury, stroke, epilepsy, Parkinson's disease, or psychiatric disorders. 2. Prior history of metabolic diseases known to cause cognitive decline, including anemia, thyroid dysfunction, folate deficiency, vitamin B12 deficiency, etc. 3. History of alcohol or drug abuse within 2 years prior to screening. 4. Post-craniotomy or skull defect. 5. Presence of metallic or electronic device implants (e.g., cardiac pacemaker, cochlear implant, deep brain stimulator, aneurysm clip, internal fixation device following ventriculoperitoneal shunt, etc.). 6. Other serious diseases that may interfere with the study. 7. Concurrent participation in other clinical studies.

Design outcomes

Primary

MeasureTime frame
Alzheimer's Disease Assessment Scale - Cognitive Subscale;

Secondary

MeasureTime frame
Mini-Mental State Examination;Montreal Cognitive Assessment - Basic;Clinical Dementia Rating Scale;Neuropsychiatric Inventory;Functional Activities Questionnaire;Auditory Verbal Learning Test - Huashan Version;Pittsburgh Sleep Quality Index;Boston Naming Test;Digit Span Test;Electroencephalography;Resting-state Functional Magnetic Resonance Imaging;Diffusion Tensor Imaging;functional near-infrared spectroscopy;

Countries

China

Contacts

Public ContactXiquan Hu

The Third Affiliated Hospital of Sun Yat-Sen University

huxiquan@mail.sysu.edu.cn+86 132 2942 8260

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026