Efficacy and Safety of Temporal Interference Stimulation on Cognitive Function in Patients With Early-Stage Alzheimer's Disease
Enrolling by invitation · Not applicable · Has a placebo group
Conditions studied: Alzheimer Disease
In brief
This study aims to investigate the efficacy and safety of a novel non-invasive brain stimulation technique-Temporal Interference Stimulation (TIS)-in patients with early-stage Alzheimer's disease. A total of 40 participants will be randomly assigned to either the TIS group or the sham stimulation group. The intervention will last for 2 weeks, with cognitive and safety assessments at baseline, post-treatment, and 12 weeks after treatment.
Key facts
- Study ID
- NCT07543094
- Run by
- Ruijin Hospital
- People needed
- 40
- Starts
- 2025-11-01
- Expected to finish
- 2027-09-30
- Last updated by the study team
- 2026-04-24
Who can join
Age: 50 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Current or past history of significant neurological disorders other than AD (e.g., epilepsy, stroke, multiple sclerosis), intracranial lesions, neurosurgery, or significant head trauma.
- Current use of medications that may substantially impair cognitive function (e.g., anticonvulsants, antipsychotics, benzodiazepines).
- Any contraindication for MRI or the stimulation device (e.g., metallic implants, pacemakers, severe claustrophobia).
- Significant structural brain abnormalities on MRI (e.g., hydrocephalus, stroke, or severe white matter lesions [Fazekas score ≥ 3]).
- Diagnosis of major depression or other active, uncontrolled psychiatric disorders.
- Any severe or unstable medical condition that, in the investigator's judgment, could compromise participant safety or study validity (e.g., cardiovascular, renal, hepatic, respiratory, active cancer), or a history of alcohol/substance dependence.
Where it is running
- Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China
Full record on ClinicalTrials.gov
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