Temporal Interference Stimulation: Device: The non-invasive brain stimulator NervioX is used to administer Temporal Interference Stimulation (TIS).
Stimulation Parameters:
Frequencies: 2000 Hz and 2005 Hz (resulting in a 5 Hz theta rhythm envelope). Stimulation Intensity: 1.0-2.0 mA (peak current). Stimulation Target: Bilateral hippocampus Session Duration: 40 minutes per session. Treatment Course: 5 sessions per week, for 2 consecutive weeks, totaling 10 sessions.
Sham Stimulation: Device: The same NervioX device is used.
Stimulation Parameters:
The device is programmed to deliver a real stimulation (1.0-2.0 mA) for the initial 30 seconds of the session to mimic the initial sensation experienced by the active group.
Subsequently, the current is automatically reduced to 0 mA for the remainder of the 40-minute session.
The device screen continues to display the stimulation as ongoing to maintain the blinding.
The session frequency and total course (5 sessions/week for 2 weeks, 10 sessions total) are identical to the active intervention group.
Study summary
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.
Eligibility
Sex
ALL
Min age
50 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria：
1. According to the 2024 NIA-AA Revised Criteria , defined as positivity for at least one Core 1 biomarker:
* Positive plasma p-tau217 test (positivity defined by clinically validated diagnostic cutoffs provided by the assay manufacturer); or
* Positive amyloid PET scan; or
* Abnormal cerebrospinal fluid (CSF) ratios, including p-tau181/Aβ42, t-tau/Aβ42, or Aβ42/40.
\*Reference: Revised criteria for diagnosis and staging of Alzheimer's disease: Alzheimer's Association Workgroup. Alzheimers Dement. 2024 Aug;20(8):5143-5169.\*
2. Age between 50 and 75 years, inclusive.
3. Minimum of 6 years of formal education.
4. Clinical Dementia Rating (CDR) global score of 0.5 or 1.0.
5. MMSE≥21.
6. Stable dosage of cognitive-enhancing medications (e.g., cholinesterase inhibitors and/or memantine) for at least 6 weeks prior to screening.
Exclusion Criteria:
1. Current or past history of significant neurological disorders other than AD (e.g., epilepsy, stroke, multiple sclerosis), intracranial lesions, neurosurgery, or significant head trauma.
2. Current use of medications that may substantially impair cognitive function (e.g., anticonvulsants, antipsychotics, benzodiazepines).
3. Any contraindication for MRI or the stimulation device (e.g., metallic implants, pacemakers, severe claustrophobia).
4. Significant structural brain abnormalities on MRI (e.g., hydrocephalus, stroke, or severe white matter lesions \[Fazekas score ≥ 3\]).
5. Diagnosis of major depression or other active, uncontrolled psychiatric disorders.
6. 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.
Primary outcome measure(s)
Changes in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 11) Score — Baseline, End of treatment (2 weeks) The ADAS-Cog 11 is a rater-administered scale designed to assess the severity of cognitive dysfunction in Alzheimer's disease. The total score ranges from 0 to 70, with a lower score indicating better cognitive performance. The change from baseline to the end of treatment will be analyzed.
Trial sites (1)
Facility
City
Region
Status
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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