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

NCT07324161 · tracked via the Priya Life Science China tracker

Sponsor

Fujian Medical University Union Hospital

Phase

Not applicable

Started

2025-04-16

Last updated

2026-08-31

Condition(s) studied

Alzheimer s Disease

Investigational drug(s) / intervention(s)

rTMSsham rTMSAccelerated rTMS

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.

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

Accelerated 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.

Study 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.

Eligibility

Sex

ALL

Min age

50 Years

Max age

90 Years

Healthy volunteers

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

Primary outcome measure(s)

MoCA Changes from baseline to post-treatment — Baseline vs 2 weeks and 6 months after treatment
Montreal Cognitive Assessment (MoCA)

Trial sites (1)

Facility	City	Region	Status
rTMS	Fuzhou	Fujian	Recruiting

More Fujian Medical University Union Hospital trials in China

A Clinical Trial Evaluating the Efficacy and Safety of Disitamab Vedotin Plus Tislelizumab Combined with Re-TURBT in the Treatment of HER-2-high Expression(2+-3+) Non-muscle Invasive Bladder Cancer At High-risk and Very High-risk. Starting soon

Chemotherapy-immunotherapy-based Split-course Adaptive Hypofractionated Radiotherapy for Extensive-stage SCLC Enrolling by invitation

Study Compare Adjuvant Chemotherapy, Chemoradiotherapy and Surgery Alone for pN1-2(pT1b-3N1-2M0) Esophageal Carcinoma Recruiting

The Value of Indocyanine Green-guided Near-infrared Fluorescence Technology in Tracing Sentinel Lymph Nodes During Esophagectomy Starting soon

Postoperative Radiotherapy in Thoracic Esophageal Squamous Cell Carcinoma With Neoadjuvant Chemoradiotherapy Recruiting

Other trials for the same condition

Personalized Brain Stimulation for Cognitive Impairment in Older Adults Enrolling by invitation

Near-infrared Light Therapy Device for Mild-Moderate Alzheimer's Disease (NirsCure-03A) Recruiting

Deep Cervical Lymphovenous Anastomosis for Severe Alzheimer's Disease Starting soon

[18F]NIDF PET Imaging in Tau-related Diseases Recruiting

Evaluating the Efficacy and Safety of Lecanemab in Alzheimer's Disease Through Multi-omics Approachs Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07324161 on ClinicalTrials.gov ↗ ← All trials in China