Actively Recruiting
Efficacy and Safety of Repetitive Transcranial Magnetic Stimulation in the Treatment of Alzheimer's Disease and Exploration of Glymphatic Mechanisms
Led by Fujian Medical University Union Hospital · Updated on 2026-01-14
66
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the use of repetitive transcranial magnetic stimulation (rTMS) as a treatment for Alzheimer's disease (AD), focusing on its clinical effectiveness and safety. This study explores how rTMS affects the glymphatic system, which is important for brain health, by using advanced techniques like TMS-EEG and functional near-infrared spectroscopy (fNIRS) to understand its impact on brain functions such as synaptic plasticity and neurovascular coupling. Participants will receive either real rTMS or sham (placebo) rTMS using a Cool-B65 stimulation coil. Treatment involves daily sessions lasting 20 minutes, five days a week, for two weeks, delivering 1600 magnetic pulses per session. After the initial treatment, consolidation therapy is provided weekly for six months. The study is randomized and triple-blinded to compare the effects of the active and sham treatments. During the study, participants will undergo assessments including the Montreal Cognitive Assessment (MoCA), Clinical Dementia Rating (CDR), Mini-Mental State Examination (MMSE), Neuropsychiatric Inventory (NPI), and evaluations of neuropathological markers and brain activity changes through TMS-EEG. These measures are taken at baseline, two weeks, and six months after treatment to monitor cognitive changes and treatment effects. The study lasts up to six months post-treatment, with safety and clinical outcomes carefully monitored throughout.
CONDITIONS
Brief Title
Efficacy and Safety of Transcranial Magnetic Stimulation in Treatment of Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meets the 2018 NIA-AA diagnostic criteria for Alzheimer's disease
- Meets DSM-5 diagnostic criteria
- Mild to moderate disease severity with CDR Global Score 1 to 2
- Evidence of Alzheimer's disease pathology: positive amyloid PET or positive cerebrospinal fluid biomarkers or positive plasma biomarkers
- Aged between 50 and 90 years
You will not qualify if you...
- Contraindications to rTMS treatment
- Severe complications or immune diseases
- Unable to cooperate with study procedures
- History of epilepsy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 2 weeks
Participants receive daily repetitive transcranial magnetic stimulation (rTMS) or sham treatment for two weeks, with sessions occurring 5 days a week.
10 daily visits (in-person)
Duration - 6 months
Participants receive weekly consolidation therapy sessions after the initial two-week treatment period, continuing for 6 months.
Weekly visits (in-person)
Trial Site Locations
Total: 1 location
1
rTMS
Fuzhou, Fujian, China, 350001
Actively Recruiting
Research Team
X
Xiaodong Pan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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