Efficacy and Safety of Transcranial Magnetic Stimulation in Treatment of Alzheimer's Disease

ConditionAlzheimer s Disease

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age50-90

SponsorFujian Medical University Union Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Contraindications to rTMS treatment

Severe complications or immune diseases

Unable to cooperate with study procedures

History of epilepsy

Trial design

Design model

Parallel

Treatments tested in this trial

rTMS
Device
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.
sham rTMS
Device
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
Device
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.

Treatment groups

81 Participants

are divided into 3 treatment groups

Group A: rTMSExperimental treatment 1 intervention

Group B: sham rTMSSham comparator 1 intervention

Group C: Accelerated rTMSActive comparator 1 intervention

Trial outcomes