The Study of Transcranial Magnetic Stimulation in the Regulation of Spinocerebellar Ataxia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Scale for the assessment and rating of ataxia
研究概览
简要总结
Spinocerebellar ataxia (SCA) is a group of hereditary neurological diseases caused by gene mutations leading to degenerative changes in the cerebellum, brainstem, and spinal cord. A key pathogenic mechanism of SCA is the repeated expansion of cytosine - adenine - guanine (CAG) trinucleotides in the coding region of specific genes. These repeated expansions are translated into abnormally large polyglutamine (PolyQ) tracts in proteins. These polyglutamine (PolyQ) tracts can cause changes in the excitability of the cerebral cortex in SCA patients. Quantitative electroencephalogram analysis (qEEG) is a modern type of electroencephalogram analysis that uses complex mathematical algorithms to process, transform, and analyze EEG signals, bringing new technologies for EEG signal feature extraction: specific frequency band and signal complexity analysis, connectivity analysis, and network analysis. It is sensitive to early neurodegenerative lesions. Using spectral analysis, nonlinear dynamics analysis, and functional connectivity analysis, we can explore the changes in cortical excitability and abnormal brain networks in SCA patients. Currently, the exploration of the quantitative electroencephalogram characteristics of SCA patients is still insufficient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Spinocerebellar ataxia patients confirmed through genetic testing
- •Patient aged 18-75
- •Patients who can walk independently (with the aid of a cane/walker) without assistance from others.
- •The SARA score exceeds 3.
排除标准
- •Patients with unstable neurological disorders or accompanying medical conditions (such as stroke, arthritis, etc.)
- •Patients with significantly abnormal clinical indicators identified during screening
- •Patients concurrently participating in another clinical study
- •Patients with untreated intracranial hypertension, depression, dementia, or psychiatric disorders
- •Patients with severe heart disease
- •Patients who are wheelchair users
- •pregnant woman
- •Patients who cannot establish their identity or have limited legal capacity
- •Patients with contraindications for rTMS, including metallic objects in the head, history of neurosurgery, ferromagnetic bioimplants, metal coatings, history of seizures, autism, current use of protease inhibitors or other medications that may increase the risk of rTMS-induced seizures.
研究组 & 干预措施
Test group
Perform low-frequency Transcranial Magnetic Stimulation (TMS) on the left and right cerebellar hemispheres and the vermis of the cerebellum, twice a day for a total of 7 days.
干预措施: Transcranial magnetic stimulation (Other)
Controls
The healthy control group does not receive any intervention.
结局指标
主要结局
Scale for the assessment and rating of ataxia
时间窗: Baseline and one week post-baseline (after treatment)
The Scale for the Assessment and Rating of Ataxia (SARA) is a clinical tool used to assess the severity of ataxia. The total score range of the SARA scale is 0 to 40 points, with higher scores indicating more severe ataxia symptoms.
Resting - state electroencephalogram
时间窗: baseline and one week post-baseline (after treatment)
Use electroencephalogram (EEG) to collect the electroencephalogram data of participants with their eyes closed and in a waking state.Using spectral analysis, nonlinear dynamics analysis, and functional connectivity analysis, we can explore the changes in cortical excitability and abnormal brain networks in SCA patients.
Transcranial Magnetic Stimulation - Electroencephalogram（TMS-EEG）
时间窗: Baseline and one week post-baseline (after treatment)
Transcranial magnetic stimulation is utilized to stimulate the brain, and then EEG data is immediately collected from participants using EEG to collect closed-eye, awake EEG data.Using time-frequency analysis, nonlinear dynamics analysis, and functional connectivity analysis, we can explore the changes in cortical excitability and abnormal brain networks in SCA patients.
次要结局
- The Neurological Examination Score for the assessment of Spinocerebellar Ataxias (NESSCA)(Baseline and one week post-baseline (after treatment))
- The EQ Visual Analogue Scale(Baseline and one week post-baseline (after treatment))
- Gait analysis(Baseline and one week post-baseline (after treatment))
- The International Cooperative Ataxia Rating Scale (ICARS)(Baseline and one week post-baseline (after treatment))
研究者
Fei Xiao
Professor
First Affiliated Hospital of Chongqing Medical University