An interventional study of Real repetitive transcranial magnetic stimulation and Sham repetitive transcranial magnetic stimulation in Alzheimer Disease, sponsored by First Affiliated Hospital of Zhejiang University. Recruiting at 1 site in China. Open to participants aged 55 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-05-11.
Sponsored by First Affiliated Hospital of Zhejiang University · Not applicable, Interventional, and Treatment
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).
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.
3,675 studies on the registry are indexed under Alzheimer Disease; 869 are open to participants now.
This study's planned enrollment of 30 is below the median of 70 across 2,805 interventional studies indexed under Alzheimer Disease.
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Exclusion Criteria:
participants will receive10 sessions of high frequency rTMS treatment applied to the dorsolateral prefrontal cortex over a 5 days real rTMS
Device: Real repetitive transcranial magnetic stimulation
participants will receive10 sessions of high frequency rTMS treatment applied to the dorsolateral prefrontal cortex over a 5 days sham rTMS
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 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
Cognitive funtion
Multidimensional neuropsychological assessment is mainly used to assess the cognitive function of patients. Global cognitive assessment included mini-mental state examination (MMSE) and Montreal Cognitive assessment scale (MoCA). MMSE is widely used in cognitive dysfunction which consists of the following ten parts: orientation, memory, attention and numeracy, ability to recall, language skills, including naming ability, retelling ability, three-step command, reading ability, writing ability. The values range from 0 to 30, with higher score indicating better outcome. MoCA is also an assessment tool for rapid screening of cognitive dysfunction, including 8 cognitive domains such as visual structure skills, executive function, memory, language, attention and concentration, calculation, abstract thinking and orientation. The values range from 0 to 30, with higher score indicating better outcome.
Time frame: at baseline (T0), immediately after the end of the treatment (T1), 1month later (T2),3months later
Sleep parameters
Changes in in sleep/wake architecture assessed by polysomnography. Electrodes attached to the scalp near the frontal, central (top) and occipital (back) portions of the brain and provide a readout of different stages of sleep (N1, N2, N3, REM, and Wakefulness). Total sleep time (TST), sleep efficiency (SE), the percentage of rapid eye movement (REM) sleep time in total sleep time, and the percentage of non-rapid eye movement sleep time in total sleep time were mainly analyzed.
Time frame: at baseline (T0), immediately after the end of the treatment (T1), 1month later (T2),3months later
glymphatic system
ALPS-index is a non-invasive diffusion tensor image-based method to measure diffusivity along the perivascular space (ALPS), which measures diffusivity in the direction of the perivascular space in the periventricular white matter. It has been proposed to be an indirect indicator of the state of glymphatic function. ALPS-index = mean(Dxxproj; Dxxasso)/mean(Dyyproj; Dzzasso) Dxxproj means diffusivity along the x-axis in the projection fiber. Dxxassoci means diffusivity along the x-axis in the association fiber. Dyyproj means diffusivity along the y-axis in the projection fiber, Dzzassoci means diffusivity along the z-axis in the association fiber. The values was greater than 0 with lower score indicating more damaged.
Time frame: at baseline (T0), immediately after the end of the treatment (T1), 1month later (T2),3months later
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First Affiliated Hospital of Zhejiang University