Clinical trial NCT06379100: Cerebellar ITBS Mode Transcranial Magnetic Stimulation for the Treatment of Alzheimer's Disease
Official title: A Randomized, Controlled Clinical Study on Cerebellar ITBS Mode Transcranial Magnetic Stimulation for the Treatment of Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transcranial Magnetic Stimulation
Alzheimer Disease
Magnetic Resonance Imaging
Electroencephalogram
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: The changes in CDR（Clinical Dementia Rating）
timeFrame: baseline, 4 weeks after start of the treatment
Secondary outcomes:
measure: The changes in MMSE(Mini Mental State Examination)
timeFrame: baseline, 4 weeks and 4 weeks after treatment
measure: NPI (Neuropsychiatric Inventory)
timeFrame: baseline, 4 weeks and 4 weeks after treatment
measure: ADL( Lawton-Brody Activities of Daily Living)
timeFrame: baseline, 4 weeks and 4 weeks after treatment
measure: DST (Digital Span Test; Forward and Backward)
timeFrame: baseline, 4 weeks and 4 weeks after treatment
measure: ADAS-cog（Alzheimer's disease assessment scale)
timeFrame: baseline, 4 weeks and 4 weeks after treatment
measure: DMS(Delayed matching-to-sample task)
timeFrame: baseline, 4 weeks and 4 weeks after treatment
measure: MEP（Motor evoked potential）
timeFrame: baseline, 4 weeks and 4 weeks after treatment
measure: MRI measures
timeFrame: baseline, 4 weeks and 4 weeks after treatment
measure: EEG（electroencephalogram）
timeFrame: baseline, 4 weeks and 4 weeks after treatment
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital of Air Force Military Medical University
state: Shaanxi
Study officials:
affiliation: The First Affiliated Hospital of Air Force Medicial University
name: Wen Jiang
role: STUDY_CHAIR
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