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
First Affiliated Hospital of Zhejiang University
30 participants
Mar 16, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria9
- 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.
- Age range: 55-80 years.
- No visual or hearing impairment.
- Right-handed.
- Han nationality.
- Signed informed consent.
- Reliable caregivers as information providers.
- MMSE score: 10-27; CDR: 0.5-2 points.
- 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 Criteria12
- History of seizures or epilepsy diagnosis;
- Stroke history;
- 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);
- Severe liver/kidney/lung dysfunction, anemia, gastrointestinal disease, arrhythmia, recent MI;
- Barbiturate/benzodiazepine use within 2 weeks;
- MRI/TMS contraindications (metallic implants);
- Systemic diseases causing cognitive impairment (hypothyroidism, folate/B12 deficiency, infections, alcohol/drug abuse);
- Aphasia, consciousness disturbance, inability to cooperate;
- TMS/tDCS/DBS has been processed;
- Underlying pathology other than AD;
- Focal brain lesions on T1/T2 images;
- Refusal to sign informed consent.
Interventions
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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06385106