NCT06385106

Effects of Repetitive Transcranial Magnetic Stimulation in Patients With Alzheimer's Disease

Effects of Repetitive Transcranial Magnetic Stimulation on Sleep and Cognitive Function in Patients With Alzheimer's Disease: a Randomized, Double-blind, Controlled Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 55 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Previous studies have shown that repetitive transcranial magnetic stimulation (rTMS) can improve cognitive function in Alzheimer's disease (AD), but studies on the improvement of sleep disorders in AD are limited. The aim of this study was to evaluate the effects of rTMS on sleep and cognition in patients with mild-to-moderate Alzheimer's disease (AD).

Detailed description

Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation technique. Some studies have showed that its positive effects in patients with Alzheimer's disease. The aim of this study was to evaluate the effect of rTMS on sleep and cognitive function in patients with mild to moderate AD, and to evaluate the glymphatic system function's mediating role between sleep and cognitive function. The study involves participants receiving 10 sessions of high frequency rTMS treatment applied to the dorsolateral prefrontal cortex over a 5 days period or sham rTMS. Neuropsychological testing and polysomnography will be used as the primary outcome measures. In addition, magnetic resonance imaging will be used to explore the effect of rTMS on the glymphatic system function in patients with Alzheimer's disease. Follow-up assessments of the patients' status will be conducted at one and three-month intervals.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DEVICE	Real repetitive transcranial magnetic stimulation	The target brain region for stimulation was the left dorsolateral prefrontal lobe. The intensity of the stimulation was 80% of the resting motor threshold (MT) of each subject. In the target brain region, we applied 40 stimuli at a frequency of 20 Hz and the MT for 1600 pulses per session.
DEVICE	Sham repetitive transcranial magnetic stimulation	The target brain region for stimulation was the left dorsolateral prefrontal lobe. The intensity of the stimulation was 80% of the resting motor threshold (MT) of each subject. In the target brain region, we applied 40 stimuli at a frequency of 20 Hz and the MT for 1600 pulses per session. The patients were applied with the coil angled away from the head to reproduce the noise of the stimulation as well as some local sensation

Timeline

• Start date: 2024-03-16
• Primary completion: 2025-12-01
• Completion: 2026-01-01
• First posted: 2024-04-25
• Last updated: 2025-05-11

Locations

1 site across 1 country: China