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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
81
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.
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
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.
rTMS
Fuzhou, Fujian, China
RECRUITINGMoCA Changes from baseline to post-treatment
Montreal Cognitive Assessment (MoCA)
Time frame: Baseline vs 2 weeks and 6 months after treatment
CDR Changes from baseline to post-treatment
Clinical Dementia Rating (CDR)
Time frame: Baseline vs 2 weeks and 6 months after treatment
ACE-III Changes from baseline to post-treatment
Addenbrooke's Cognitive Examination III
Time frame: Baseline vs 2 weeks and 6 months after treatment
MMSE Changes from baseline to post-treatment
Mini-Mental State Examination (MMSE)
Time frame: Baseline vs 2 weeks and 6 months after treatment
NPI Changes from baseline to post-treatment
Neuropsychiatric Inventory (NPI)
Time frame: Baseline vs 2 weeks and 6 months after treatment
Neuropathological markers Change from baseline to post-treatment
Aβ, tau, GFAP, NFL, VEGF
Time frame: Baseline vs 2 weeks and 6 months after treatment
TMS-EEG Changes from baseline to post-treatment
Concurrent transcranial magnetic stimulation and electroencephalography (TMS-EEG)
Time frame: Baseline vs 2 weeks and 6 months after treatment
fNIRS
functional near-infrared spectroscopy
Time frame: Baseline vs 2 weeks and 6 months after treatment
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