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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

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: rTMSExperimental treatment 1 intervention
Group B: sham rTMSSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

MoCA Changes from baseline to post-treatment

Montreal Cognitive Assessment (MoCA)

Time frame
Baseline vs 2 weeks and 6 months after treatment

Secondary outcomes

1

CDR Changes from baseline to post-treatment

Clinical Dementia Rating (CDR)

Time frame
Baseline vs 2 weeks and 6 months after treatment
2

MMSE Changes from baseline to post-treatment

Mini-Mental State Examination (MMSE)

Time frame
Baseline vs 2 weeks and 6 months after treatment
3

NPI Changes from baseline to post-treatment

Neuropsychiatric Inventory (NPI)

Time frame
Baseline vs 2 weeks and 6 months after treatment
4

Neuropathological markers Change from baseline to post-treatment

Aβ, tau, GFAP, NFL, VEGF

Time frame
Baseline vs 2 weeks and 6 months after treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fujian Medical University Union Hospital

Lead sponsor

Source ClinicalTrials.gov
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