Rehabilitative Trial With Cerebello-Spinal tDCS for the Treatment of Neurodegenerative Ataxia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline
研究概览
简要总结
Neurodegenerative cerebellar ataxias represent a group of disabling disorders for which we currently lack effective therapies. Cerebellar transcranial direct current stimulation (tDCS) is a non-invasive technique, which has been demonstrated to modulate cerebellar excitability and improve symptoms in patients with cerebellar ataxias. In this randomized, double-blind, sham-controlled study, the investigators will evaluate whether a two-weeks' treatment with cerebellar anodal tDCS and spinal cathodal tDCS can improve symptoms in patients with neurodegenerative cerebellar ataxia and can modulate cerebello-motor connectivity, at short and long term.
详细描述
Neurodegenerative cerebellar ataxias represent a heterogeneous group of disabling disorders in which progressive ataxia of gait, limb dysmetria, oculomotor deficits, dysarthria and kinetic tremor are the prominent clinical manifestations. Both the hereditary and sporadic forms usually present in young adulthood, and are characterized by atrophy of cerebellar or brainstem structures. Currently, cerebellar ataxia lack effective disease-modifying therapies.
Cerebellar transcranial direct current stimulation (tDCS) is a non-invasive technique, which has been demonstrated to modulate cerebellar excitability and improve symptoms in patients with cerebellar ataxias. The present randomized, double-blind, sham-controlled study will investigate whether a two-weeks' treatment with cerebellar anodal tDCS and spinal cathodal tDCS can improve symptoms in patients with neurodegenerative cerebellar ataxia and can modulate cerebello-motor connectivity, at short and long term.
Subjects will be randomized in two groups, one receiving a 10 day (5 days/week for 2 weeks) treatment with anodal cerebellar and cathodal spinal tDCS and the other receiving sham stimulation with identical parameters. After the intervention, patients will be reassessed with a clinical and neurophysiological evaluation at 2 weeks, 1 months and 3 month after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a cerebellar syndrome and quantifiable cerebellar atrophy
排除标准
- •Severe head trauma in the past
- •History of seizures
- •History of ischemic stroke or hemorrhage
- •Pacemaker
- •Metal implants in the head/neck region
- •Severe comorbidity
- •Intake of illegal drugs
- •Pregnancy
结局指标
主要结局
Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline
时间窗: Baseline - 2 weeks
International Cooperative Ataxia Rating Scale (ICARS): semi-quantitative 100-point scale, yielding a total score of 0 (no ataxia) to 100 (most severe ataxia).
Change in the Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline
时间窗: Baseline - 2 weeks
Scale for the Assessment and Rating of Ataxia (SARA): 8-item performance based scale, yielding a total score of 0 (no ataxia) to 40 (most severe ataxia).
次要结局
- Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline(Baseline - 2 weeks - 1 month - 3 months)
- Change in the Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline(Baseline - 2 weeks - 1 month - 3 months)
- Change in the 8-Meter Walking Time (8MW) Score From Baseline(Baseline - 2 weeks - 1 month - 3 months)
- Change in the Short-Form Health Survey 36 (SF36) Score From Baseline(Baseline - 2 weeks - 1 month - 3 months)
- Change in the 9 Hole Peg Test (9HPT) Score From Baseline(Baseline - 2 weeks - 1 month - 3 months)
- Change in Cerebellar Brain Inhibition (CBI) Measurements From Baseline(Baseline - 2 weeks - 1 month - 3 months)
研究者
Barbara Borroni
Professor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia