Cerebellar ITBS Mode Transcranial Magnetic Stimulation for the Treatment of Alzheimer's Disease
- Conditions
- Magnetic Resonance ImagingElectroencephalogramAlzheimer DiseaseTranscranial Magnetic Stimulation
- Interventions
- Device: transcranial magnetic stimulation
- Registration Number
- NCT06379100
- Lead Sponsor
- Xijing Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Age: 45-80 years old;
- 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
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Central nervous system degenerative diseases other than Alzheimer's disease
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Previous history of epilepsy (excluding febrile seizures in childhood)
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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)
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Cerebrovascular disease (excluding lacunar infarction), severe infection, malignant tumor, accompanied by severe dysfunction of organs such as heart, liver, and kidney
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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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Transcranial Magnetic Stimulation-Real transcranial magnetic stimulation Participants will receive active TMS once daily for four weeks Transcranial Magnetic Stimulation-Sham transcranial magnetic stimulation Participants will receive sham TMS once daily for four weeks
- Primary Outcome Measures
Name Time Method The changes in CDR（Clinical Dementia Rating） 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
- Secondary Outcome Measures
Name Time Method The changes in MMSE(Mini Mental State Examination) 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.
EEG（electroencephalogram） 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
ADL( Lawton-Brody Activities of Daily Living) 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.
MEP（Motor evoked potential） 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.
NPI (Neuropsychiatric Inventory) 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.
DST (Digital Span Test; Forward and Backward) 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.
ADAS-cog（Alzheimer's disease assessment scale) 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.
DMS(Delayed matching-to-sample task) 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.
MRI measures 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.
Trial Locations
- Locations (1)
Xijing Hospital of Air Force Military Medical University
🇨🇳Xi'an, Shaanxi, China