Real repetitive transcranial magnetic stimulationSham repetitive transcranial magnetic stimulation
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.
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
Study 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).
Eligibility
Sex
ALL
Min age
55 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. Participant meets 2014 IWG-2 criteria for hippocampal amnestic syndrome, typical of AD, with progressive episodic memory impairment confirmed by neuropsychology. Cerebrospinal fluid markers (Aβ40, Aβ42, T-tau, p-tau) consistent with AD, or AV-45 PET imaging showing significant cortical tracer retention, in line with AD pathophysiology.
2. Age range: 55-80 years.
3. No visual or hearing impairment.
4. Right-handed.
5. Han nationality.
6. Signed informed consent.
7. Reliable caregivers as information providers.
8. MMSE score: 10-27; CDR: 0.5-2 points.
9. If receiving approved AD treatment (e.g., acetylcholinesterase inhibitor or memantine), dose must be stable for ≥3 months prior to screening and unchanged unless medically necessary.
Exclusion Criteria:
1. History of seizures or epilepsy diagnosis;
2. Stroke history;
3. Nervous system diseases causing brain dysfunction (schizophrenia, severe anxiety/depression, dementia, Huntington's, brain tumors, Parkinson's, metabolic encephalopathy, encephalitis, MS, epilepsy, brain trauma, hydrocephalus);
4. Severe liver/kidney/lung dysfunction, anemia, gastrointestinal disease, arrhythmia, recent MI;
5. Barbiturate/benzodiazepine use within 2 weeks;
6. MRI/TMS contraindications (metallic implants);
7. Systemic diseases causing cognitive impairment (hypothyroidism, folate/B12 deficiency, infections, alcohol/drug abuse);
8. Aphasia, consciousness disturbance, inability to cooperate;
9. TMS/tDCS/DBS has been processed;
10. Underlying pathology other than AD;
11. Focal brain lesions on T1/T2 images;
12. Refusal to sign informed consent.
Primary outcome measure(s)
Cognitive funtion — at baseline (T0), immediately after the end of the treatment (T1), 1month later (T2),3months later 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.
Sleep parameters — at baseline (T0), immediately after the end of the treatment (T1), 1month later (T2),3months later 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.
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of Zhejiang University
Hangzhou
Zhejiang
Recruiting
More First Affiliated Hospital of Zhejiang University trials in China
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.
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