Cerebellar ITBS Mode Transcranial Magnetic Stimulation for the Treatment of Alzheimer's Disease

October 10, 2024 updated by: Xijing Hospital

A Randomized, Controlled Clinical Study on Cerebellar ITBS Mode Transcranial Magnetic Stimulation for the Treatment of Alzheimer's Disease

Study the therapeutic effect and potential neural mechanisms of cerebellar iTBS mode transcranial magnetic stimulation on Alzheimer's disease patients through MRI and EEG.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study intends to apply intermittent therapy for the first time θ The Outbreak Stimulation (iTBS) mode was used for rTMS treatment in the cerebellum of Alzheimer's disease (AD). This was a randomized, double-blind, parallel, and sham stimulation controlled clinical trial, which included 28 AD patients. All patients were randomly divided into the iTBS group and the sham stimulation group. Collect clinical information, scales, magnetic resonance imaging, TMS synchronous electroencephalography, polysomnography monitoring, etc., and then perform TMS/false stimulation treatment on subjects for 4 weeks (a total of 20 times); After treatment and one month follow-up, relevant scales, magnetic resonance imaging, TMS synchronous electroencephalogram and other data were collected again, and appropriate statistical methods were used to analyze the therapeutic effect.

Study Type

Interventional

Enrollment (Actual)

20

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 Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital of Air Force Military Medical University

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. Age: 45-80 years old;
  2. Meets the NIA-AA standards established by the National Institute on Aging in the United States; Cerebrospinal fluid presents as A β decrease and increase tau protein.

3 The MMSE score ranges from 18 to 26, and the Clinical Dementia Rating (CDR) score is 0.5 to 1 4 At least one adult caregiver 5 patients have received treatment with acetylcholinesterase inhibitors (AChEI) or memantine, such as donepezil, galantamine, or gabalin

  • Medication for at least 3 months
  • The current dosing regimen remains stable for 8 weeks
  • The medication plan remains stable throughout the entire process 6. At least 8 years of educational experience 7 Patients and their families voluntarily sign informed consent forms

Exclusion Criteria:

  1. Central nervous system degenerative diseases other than Alzheimer's disease
  2. Previous history of epilepsy (excluding febrile seizures in childhood)

  3. According to the Diagnostic and Statistical Manual of Mental Disorders, the Fourth Edition - Text Revised Edition (DSM IV-TR) standard meets any of the following:

    • Depression (currently)
    • Schizophrenia
    • Other psychiatric disorders, bipolar disorder, or substance dependence (including alcohol) (within the past 5 years)
  4. Cerebrovascular disease (excluding lacunar infarction), severe infection, malignant tumor, accompanied by severe dysfunction of organs such as heart, liver, and kidney

  5. There are contraindications for transcranial magnetic stimulation and MRI, or there are metal or implanted devices in the body, such as pacemakers, deep brain stimulators, etc; 6 Use any of the following medications for treatment within the past 3 months:

    • Typical and atypical antipsychotic drugs (such as clozapine, olanzapine)
    • Antiepileptic drugs (such as carbamazepine, topiramate, sodium valproate) 7 has received TMS treatment in the past 8 Participate in clinical trials of any drug within 6 months prior to study registration

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: Transcranial Magnetic Stimulation-Real
Participants will receive active TMS once daily for four weeks
Device: transcranial magnetic stimulation
Intermittent Theta-Burst Transcranial Magnetic Stimulation
Sham Comparator: Transcranial Magnetic Stimulation-Sham
Participants will receive sham TMS once daily for four weeks
Device: transcranial magnetic stimulation
Intermittent Theta-Burst Transcranial Magnetic Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The changes in CDR（Clinical Dementia Rating）
Time Frame: baseline, 4 weeks after start of the treatment
The changes in CDR-SB will constitute the major research outcome measure used to assess response to rTMS.There are two scoring methods for the CDR scale, namely Total Score Calculation (CDR-GS) and Sum of Six Content Calculation (CDR-SB). The scoring method used in this study is CDR-SB, with a total score of 18 points. The lower the score, the milder the symptoms
baseline, 4 weeks after start of the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The changes in MMSE(Mini Mental State Examination)
Time Frame: baseline, 4 weeks and 4 weeks after treatment
The changes in MMSE will constitute the secondary research outcome.The full name of MMSE is mini-mental state examination. The higher the score, the better. In this study, changes in MMSE scores before and after treatment were used as secondary observations.
baseline, 4 weeks and 4 weeks after treatment
NPI (Neuropsychiatric Inventory)
Time Frame: baseline, 4 weeks and 4 weeks after treatment
The changes in NPI will constitute the secondary research outcome. The Neuropsychology Scale (NPI) evaluates 12 neuropsychiatric disorders which included 10 neuropsychiatric symptoms and 2 autonomic neurological symptoms based on the caregiver's perception of the patient's behavior and the perceived distress. The lower the score, the lighter the symptoms.
baseline, 4 weeks and 4 weeks after treatment
ADL( Lawton-Brody Activities of Daily Living)
Time Frame: baseline, 4 weeks and 4 weeks after treatment
The changes in ADL will constitute the secondary research outcome. The ADL evaluates 20 items activities of daily living which included basic life ability and instrument use ability based on the caregiver's perception of the patient's behavior. The lower the score, the lighter the symptoms.
baseline, 4 weeks and 4 weeks after treatment
DST (Digital Span Test; Forward and Backward)
Time Frame: baseline, 4 weeks and 4 weeks after treatment
The changes in DST will constitute the secondary research outcome. Digital span test (DST) was commonly used to evaluate attention ability and instantaneous memory ability.
baseline, 4 weeks and 4 weeks after treatment
ADAS-cog（Alzheimer's disease assessment scale)
Time Frame: baseline, 4 weeks and 4 weeks after treatment
The changes in ADAS-cog will constitute the secondary research outcome. The lower the score, the lighter the symptoms.
baseline, 4 weeks and 4 weeks after treatment
DMS(Delayed matching-to-sample task)
Time Frame: baseline, 4 weeks and 4 weeks after treatment
The DMS paradigm is a commonly used paradigm for studying working memory. This study, combined with EEG monitoring, can investigate the changes in the encoding, maintenance, and retrieval phases of working memory.The changes in DMS will constitute the secondary research outcome.
baseline, 4 weeks and 4 weeks after treatment
MEP（Motor evoked potential）
Time Frame: baseline, 4 weeks and 4 weeks after treatment
MEP is a muscle motor complex potential recorded by stimulating the motor cortex in the contralateral target muscle; Check the overall synchronization and integrity of the transmission and transmission pathways of motor nerves from the cortex to the muscles.The changes in MEP will constitute the secondary research outcome.
baseline, 4 weeks and 4 weeks after treatment
MRI measures
Time Frame: baseline, 4 weeks and 4 weeks after treatment
This study mainly applied resting blood oxygen level dependent functional magnetic resonance imaging (BOLD), arterial spin labeling (ASL), and magnetic resonance diffusion tensor imaging (DTI) techniques to evaluate the changes in functional connectivity of the cerebellar dentate nucleus in healthy subjects and patients before and after 4 weeks of TMS treatment, as well as the changes in the cerebellar cortical white matter fiber bundles one month after treatment.
baseline, 4 weeks and 4 weeks after treatment
EEG（electroencephalogram）
Time Frame: baseline, 4 weeks and 4 weeks after treatment
Use electroencephalography to record resting state electroencephalograms before and after treatment, as well as during follow-up, as well as TMS synchronized electroencephalograms stimulated by single pulse TMS in the bilateral cerebellar dentate nucleus, and task state electroencephalograms during DMS paradigm. Analyzing changes in power spectrum, neural oscillations, and functional connectivity of EEG data before and after treatment and during follow-up
baseline, 4 weeks and 4 weeks after treatment

Collaborators and Investigators

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

Sponsor

Xijing Hospital

Investigators

  • Study Chair: Wen Jiang, Xijing Hospital of Air Force Military Medical 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)

April 20, 2024

Primary Completion (Actual)

August 1, 2024

Study Completion (Actual)

August 25, 2024

Study Registration Dates

First Submitted

April 14, 2024

First Submitted That Met QC Criteria

April 22, 2024

First Posted (Actual)

April 23, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20232388

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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