Alzheimer s Disease
Conditions
Brief summary
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
DEVICErTMS
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.
DEVICEsham 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
DEVICEAccelerated rTMS
Accelerated rTMS (iTBS)was delivered using a Cool-B65 A/P coil with individualised positioning. Stimulation intensity was set at 80% of the motor threshold. Each iTBS burst consisted of three pulses delivered at 50 Hz, with bursts repeated at 5 Hz. Stimulation was delivered in 2-s trains separated by 28-s intervals, with a total of 1,600 pulses administered over approximately 20 min. Treatment was applied once daily, 5 days per week, for two consecutive weeks. Consolidation therapy was subsequently administered once weekly for 6 months.
Sponsors
Fujian Medical University Union Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MoCA Changes from baseline to post-treatment | Baseline vs 2 weeks and 6 months after treatment | Montreal Cognitive Assessment (MoCA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CDR Changes from baseline to post-treatment | Baseline vs 2 weeks and 6 months after treatment | Clinical Dementia Rating (CDR) |
| ACE-III Changes from baseline to post-treatment | Baseline vs 2 weeks and 6 months after treatment | Addenbrooke's Cognitive Examination III |
| MMSE Changes from baseline to post-treatment | Baseline vs 2 weeks and 6 months after treatment | Mini-Mental State Examination (MMSE) |
| NPI Changes from baseline to post-treatment | Baseline vs 2 weeks and 6 months after treatment | Neuropsychiatric Inventory (NPI) |
| Neuropathological markers Change from baseline to post-treatment | Baseline vs 2 weeks and 6 months after treatment | Aβ, tau, GFAP, NFL, VEGF |
| TMS-EEG Changes from baseline to post-treatment | Baseline vs 2 weeks and 6 months after treatment | Concurrent transcranial magnetic stimulation and electroencephalography (TMS-EEG) |
| fNIRS | Baseline vs 2 weeks and 6 months after treatment | functional near-infrared spectroscopy |
Countries
China
Contacts
CONTACTXiaodong Pan
Outcome results
None listed