Using personalized brain mapping to guide rTMS treatment for mild Alzheimer's disease
A Prospective, Randomized, Double-blind, Controlled Trial of rTMS in the Treatment of Mild Alzheimer's Disease Guided by Personalized Brain Functional Sectors(pBFS)
This study is testing whether a personalized brain treatment called rTMS can improve thinking skills in people with mild Alzheimer's disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 50 Years to 90 Years |
| Sex | All |
| Sponsor | Changping Laboratory Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT05872243 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness and safety of repetitive transcranial magnetic stimulation (rTMS) guided by personalized Brain Functional Sectors (pBFS) in patients with mild Alzheimer's disease. Participants will be randomized into four groups to receive either active rTMS targeting specific brain networks or sham rTMS. The intervention involves two daily sessions over 15 days, with a total of 7200 pulses administered each day. The aim is to enhance cognitive abilities by precisely targeting individualized brain function networks identified through resting-state fMRI scans.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with mild Alzheimer's disease who meet specific cognitive and educational criteria.
Not a fit: Patients with cognitive decline due to conditions other than Alzheimer's disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve cognitive function in patients with mild Alzheimer's disease.
How similar studies have performed: Other studies have shown promise in using targeted brain stimulation techniques for cognitive enhancement, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of probable Alzheimer's disease (probable AD) based on the AD diagnostic criteria proposed by NIA-AA. * Positive PET or positive cerebrospinal fluid test results for beta-amyloid (Aβ). * Elementary school education or higher. * MMSE scores between 20 and 26 (including 20 and 26), or 18 and 26 for those with elementary school education. * Clinical Dementia Scale (CDR) score of 1, indicating mild dementia. * Stable medication for Alzheimer's disease for at least 3 months prior to treatment. * Availability of a reliable caregiver who can assist and accompany the patient throughout the study. * Voluntary participation with signed informed consent by the patient or legal guardian. Exclusion Criteria: * Patients who have other causes of cognitive decline apart from AD, including but not limited to vascular dementia, Parkinson's disease dementia, dementia with Lewy bodies, frontotemporal dementia, and dementia due to endocrine system lesions or deficiencies of folic acid, vitamin B12 or other causes. * Patients with significant focal lesions seen on MRI, including more than two infarct foci larger than 2 cm in diameter, infarct foci in key areas such as the thalamus, hippocampus, internal olfactory cortex, pars oligo-cortical, angular gyrus, cortical and other subcortical gray matter nuclei. * Patients with moderate to severe cerebral white matter degeneration ( Fazekas score of 3-6). * Patients unable to undergo TMS treatment or MRI scan due to metallic foreign bodies, implanted electronic devices, or claustrophobia. * Patients with a history of seizures or epilepsy syndrome, or seizures within the past 12 months. * Patients with acute cardiovascular and cerebrovascular events within the 3 months prior to screening. * Patients with severe cardiac, pulmonary, hepatic, renal, and other systemic diseases that cannot be controlled with conventional medications. * Patients with malignant tumors or a life expectancy of less than 1 year due to reasons other than AD. * History of alcohol or drug abuse. * Having received other TMS treatments within the past three months. * Having participated, or is currently participating in other clinical trial programs within the past three months.
Where this trial is running
Beijing
- Xuanwu Hospital, Capital Medical University — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Na Xu, Ph.D.
- Email: naxu@cpl.ac.cn
- Phone: +8618810069676
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.