NCT05872243

pBFS Guided rTMS Treating Mild Alzheimer's Disease(AD)

A Prospective, Randomized, Double-blind, Controlled Trial of rTMS in the Treatment of Mild Alzheimer's Disease Guided by Personalized Brain Functional Sectors(pBFS)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Changping Laboratory · Academic / Other
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This study aims to investigate the effectiveness and safety of rTMS treatment under the guidance of personalized Brain Functional Sectors (pBFS) for the cognitive ability of patients with mild Alzheimer's disease.

Detailed description

Alzheimer's Disease (AD) is a neurodegenerative disorder characterized by memory impairment and cognitive decline. Personalized brain functional sectors (pBFS) using resting-state functional MRI scans have shown promise in precisely identifying individualized brain function networks. In this study, we aim to select tailored stimulation sites within the working memory network (WMN) or the default mode network (DMN) as intervention targets for mild AD patients using pBFS. To evaluate the effectiveness and safety of this intervention, participants will be randomized into four groups: active repetitive transcranial magnetic stimulation (rTMS) to the WMN group, active rTMS to the DMN group, and sham rTMS to either the WMN or DMN group at a ratio of 2:2:1:1. Each participant will receive 3600 pulse active or sham rTMS in each session, consisting of two 1800 pulse treatments with a 50-minute break in between. Two separate treatment sessions will be administered daily, resulting in a sum of 7200 pulses per day. The intervention will be administered for 15 continuous days.

Conditions

• Mild Alzheimer's Disease

Interventions

Type	Name	Description
DEVICE	active rTMS	Each participant will receive two 1800 pulse active rTMS in each session, with a 50-minute break in between. Participants will receive two separate sessions daily (a sum of 7200 pulses per day). The intervention will take place for 15 continuous days.
DEVICE	sham rTMS	Each participant will receive two 1800 pulse sham rTMS in each session, with a 50-minute break in between. Participants will receive two separate sessions daily (a sum of 7200 pulses per day). The intervention will take place for 15 continuous days.

Timeline

• Start date: 2023-09-11
• Primary completion: 2024-05-31
• Completion: 2024-08-31
• First posted: 2023-05-24
• Last updated: 2023-12-06

Locations

1 site across 1 country: China