Efficacy and Safety of Transcranial Magnetic Stimulation in Treatment of Alzheimer's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: rTMS, sham rTMS.
- Who it may be relevant to
- Registry conditions: Alzheimer s Disease. Basic parameters: 50 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Repetitive Transcranial Magnetic Stimulation in the Treatment of Alzheimer's Disease and Exploration of Glymphatic Mechanisms
Overview
This study is grounded in the regulatory mechanisms of the glymphatic system and applies repetitive transcranial magnetic stimulation (rTMS) to the treatment of Alzheimer's disease (AD). The clinical efficacy and safety of rTMS will be systematically evaluated. Furthermore, transcranial magnetic stimulation-evoked potentials (TMS-EEG) and functional near-infrared spectroscopy (fNIRS) will be employed to investigate, from the perspectives of synaptic plasticity and neurovascular coupling, the mechanisms by which rTMS influences glymphatic function. Collectively, this work aims to provide new insights into both the therapeutic effectiveness and the underlying mechanisms of rTMS in AD.
Interventions
- Device rTMS
Stimulation coil Cool-B65 A CO, positioning individualised, stimulation frequency 20Hz, stimulation intensity 100% of motor threshold, stimulation number 40 pulses/train, train interval 28s, 40 trains, 1600 total stimulation pulses, total stimulation time 20 min, treatment application once a day, continuous application for two weeks, 5 days a week.Consolidation therapy was also administered weekly for 6 months. - Device sham rTMS
Stimulation coil Cool-B65 P CO, positioning individualised, stimulation frequency 20Hz, stimulation intensity 100% of motor threshold, stimulation number 40 pulses/train, train interval 28s, 40 trains, 1600 total stimulation pulses, total stimulation time 20 min, treatment application once a day, continuous application for two weeks, 5 days a week
Primary outcome measures
- MoCA Changes from baseline to post-treatment [Time frame: Baseline vs 2 weeks and 6 months after treatment]
Secondary outcome measures (5)
- CDR Changes from baseline to post-treatment [Time frame: Baseline vs 2 weeks and 6 months after treatment]
- MMSE Changes from baseline to post-treatment [Time frame: Baseline vs 2 weeks and 6 months after treatment]
- NPI Changes from baseline to post-treatment [Time frame: Baseline vs 2 weeks and 6 months after treatment]
- Neuropathological markers Change from baseline to post-treatment [Time frame: Baseline vs 2 weeks and 6 months after treatment]
- TMS-EEG Changes from baseline to post-treatment [Time frame: Baseline vs 2 weeks and 6 months after treatment]
Eligibility criteria
Inclusion criteria
- Meets the 2018 NIA-AA diagnostic criteria for Alzheimer's disease (AD)
- Meets DSM-5 diagnostic criteria
- Mild to moderate disease severity (CDR Global Score 1 to 2)
- Evidence of AD pathology: positive amyloid PET OR positive cerebrospinal fluid (CSF) AD biomarkers OR positive plasma AD biomarkers
Exclusion criteria
- Contraindications to rTMS treatment
- Severe complications or immune diseases
- Unable to cooperate with study procedures
- History of epilepsy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- rTMS — Fuzhou
Identifiers
NCT: NCT07324161 · rTMS