Comparison of Two Therapeutic Approaches of Cerebellar Transcranial Direct Current Stimulation in a Sardinian Family Affected by Spinocerebellar Ataxia 38: a Clinical and Computerized 3D Gait Analysis Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Robertson dysarthria profile
研究概览
简要总结
Spinocerebellar ataxia 38 (SCA 38) is a very rare autosomal dominant inherited disorder caused by a mutation in ELOV5 gene, specifically expressed in cerebellar Purkinje cells, encoding an enzyme involved in the synthesis of fatty acids. The present study aimed to assess the effect of cerebellar anodal transcranial direct current stimulation (tDCS) administered employing deltoid (CD-tDCS) and spinal (CS-tDCS) cathodal montage. Clinical evaluation was performed at baseline (T0), after 15 sessions of tDCS (T1) and after one month of follow-up (T2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≤ 80 and > 18 years
- •diagnosis of SCA 38 with the presence of clinical symptoms.
排除标准
- •Inability to understand and sign the informed consent
- •Presence of other severe neurological disorders
- •presence of significant medical or psychiatric illnesses
结局指标
主要结局
Robertson dysarthria profile
时间窗: Baseline, change after 3 weeks, change after 3 months
A clinical-perceptual method exploring all components potentially involved in speech difficulties. Minimum score is 0 (higher impairment) maximum score is 284 (no impairments) Higher scores indicate better speech abilties
Modified International Cooperative Ataxia Rating Scale (MICARS)
时间窗: Baseline, change after 3 weeks, change after 3 months
Modified International Cooperative Ataxia Rating Scale (MICARS) was used to rate ataxic symptoms. Scores range from 0 (no impairment) to 100 (maximum impairment) Higher scores indicate worse impairments
次要结局
- Gait Speed(Baseline, change after 3 weeks, change after 3 months)
- Step width(Baseline, change after 3 weeks, change after 3 months)
- Double support phase duration(Baseline, change after 3 weeks, change after 3 months)
研究者
Massimiliano Pau
Full Professor of Bioengineering
University of Cagliari