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

NCT06385106 | Recruiting

• 1 other identifier: rTMS in AD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Alzheimer Disease

Keywords

Alzheimer Disease; sleep; Glymphatic System; Transcranial Magnetic Stimulation; cognitive impairment

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  at baseline (T0), immediately after the end of the treatment (T1), 1month later (T2),3months later

Secondary Outcomes (1)

• glymphatic system

  at baseline (T0), immediately after the end of the treatment (T1), 1month later (T2),3months later

Study Arms (2)

Repetitive transcranial magnetic stimulation

EXPERIMENTAL

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

Sham repetitive transcranial magnetic stimulation

SHAM COMPARATOR

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

Interventions

Real repetitive transcranial magnetic stimulation DEVICE

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.

Repetitive transcranial magnetic stimulation

Sham repetitive transcranial magnetic stimulation DEVICE

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

Sham repetitive transcranial magnetic stimulation

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

Related Publications (3)

• You S, Lv T, Qin R, Hu Z, Ke Z, Yao W, Zhao H, Bai F. Neuro-Navigated rTMS Improves Sleep and Cognitive Impairment via Regulating Sleep-Related Networks' Spontaneous Activity in AD Spectrum Patients. Clin Interv Aging. 2023 Aug 15;18:1333-1349. doi: 10.2147/CIA.S416992. eCollection 2023.

  PMID: 37601952 BACKGROUND

• Siow TY, Toh CH, Hsu JL, Liu GH, Lee SH, Chen NH, Fu CJ, Castillo M, Fang JT. Association of Sleep, Neuropsychological Performance, and Gray Matter Volume With Glymphatic Function in Community-Dwelling Older Adults. Neurology. 2022 Feb 22;98(8):e829-e838. doi: 10.1212/WNL.0000000000013215. Epub 2021 Dec 14.

  PMID: 34906982 BACKGROUND

• Herring WJ, Ceesay P, Snyder E, Bliwise D, Budd K, Hutzelmann J, Stevens J, Lines C, Michelson D. Polysomnographic assessment of suvorexant in patients with probable Alzheimer's disease dementia and insomnia: a randomized trial. Alzheimers Dement. 2020 Mar;16(3):541-551. doi: 10.1002/alz.12035. Epub 2020 Jan 15.

  PMID: 31944580 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Benyan Luo, PhD

  Zhejiang University

  STUDY CHAIR

Central Study Contacts

Guoping Peng, Doctor

CONTACT

0571-87235859; pgpfc@163.com

Xiaoyan Liu, Doctor

CONTACT

0571-87235859; yy6sweet@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 25, 2024
• Study Start: March 16, 2024
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: May 11, 2025

Record last verified: 2025-05

Locations

CN (1)