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

May 7, 2025 updated by: First Affiliated Hospital of Zhejiang University

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Guoping Peng, Doctor
  • Phone Number: 0571-87235859
  • Email: pgpfc@163.com

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The First Affiliated Hospital of Zhejiang University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Repetitive transcranial magnetic stimulation
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
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 Comparator: Sham 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 patients were applied with the coil angled away from the head to reproduce the noise of the stimulation as well as some local sensation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive funtion
Time Frame: 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.
at baseline (T0), immediately after the end of the treatment (T1), 1month later (T2),3months later
Sleep parameters
Time Frame: 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.
at baseline (T0), immediately after the end of the treatment (T1), 1month later (T2),3months later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
glymphatic system
Time Frame: at baseline (T0), immediately after the end of the treatment (T1), 1month later (T2),3months later
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.
at baseline (T0), immediately after the end of the treatment (T1), 1month later (T2),3months later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Zhejiang University

Investigators

  • Study Chair: Benyan Luo, PhD, Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

April 8, 2024

First Submitted That Met QC Criteria

April 23, 2024

First Posted (Actual)

April 25, 2024

Study Record Updates

Last Update Posted (Actual)

May 11, 2025

Last Update Submitted That Met QC Criteria

May 7, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rTMS in AD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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