Personalized MCI-network guided transcranial magnetic stimulation for early Alzheimer's disease
The Safty and Efficacy of Mild Cognitiive Impairment Network Guided Transcranial Magnetic Stimulations for Patients With Early Alzheimer's Disease (SENS-eAD): A Randomized, Double-blind Trial
This trial will test whether personalized, MRI-guided transcranial magnetic stimulation can help people with early Alzheimer's disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 45 Years to 85 Years |
| Sex | All |
| Sponsor | Anhui Medical University Academic / other |
| Locations | 1 site (Hefei, Anhui) |
| Trial ID | NCT07138677 on ClinicalTrials.gov |
What this trial studies
Participants undergo baseline medical and cognitive testing and a resting-state fMRI to identify individualized dorsal prefrontal targets within an MCI-related network. They are randomized in a double-blind fashion to receive either real or sham rTMS delivered daily for 14 days, with the sham coil matching all procedures except stimulation. Randomization is stratified by MMSE (<24 vs ≥24) using variable block sizes, and patients and clinical raters are masked to allocation. The study plans about 20 participants per group and tracks safety and cognitive outcomes before and after the intervention.
Who should consider this trial
Good fit: Ideal candidates are people with mild cognitive impairment due to AD or mild AD dementia (MMSE 18-28, CDR 0.5-1) who are stable on cholinesterase inhibitors or memantine and literate in Han Chinese.
Not a fit: People with more advanced dementia, recent rTMS, psychiatric or certain neurologic disorders, MRI-incompatible implanted devices, a history of epilepsy, or recent substance abuse are unlikely to be eligible or to benefit from this intervention.
Why it matters
Potential benefit: If successful, personalized network-guided rTMS could improve or stabilize cognitive function in people with early Alzheimer's disease by targeting brain circuits most relevant to their symptoms.
How similar studies have performed: Previous rTMS studies in Alzheimer's have shown mixed but sometimes promising cognitive effects, while individualized, resting-state fMRI-guided targeting is a newer approach with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subject diagnosed as either mild cognitive impairment due to AD or mild AD dementia based on National Institute on Aging-Alzheimer's Association criteria. 2. MMSE score 18-28. 3. CDR score 0.5-1. 4. On stable treatment with IAChE or memantine for at least 6 months. 5. Literate in Han Chinese. Exclusion Criteria: 1. Recevied rTMS treatment in the past 3 months. 2. Depression or other psychiatric disorders. 3. History of head injury, stroke, epilepsy or other neurologic disease. 4. Organic brain defects on T1 or T2 images. 5. History of unexplained loss of consciousness. 6. Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, or any implanted medical device that is incompatible with MRI. 7. Family history of medication refractory epilepsy. 8. History of substance abuse within the last 6 months.
Where this trial is running
Hefei, Anhui
- Anhui Medical University — Hefei, Anhui, China (Recruiting)
Study contacts
- Study coordinator: Kai Wang, PhD
- Email: wangkai1964@126.com
- Phone: +86-0551-62922263
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.