Interventional Cross-over Study to Evaluate the Efficacy on Motor and Cognitive Performance of Transcranial Alternating Current Stimulation (tACS) in Patients With Neurodegenerative Ataxia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline
研究概览
简要总结
The aim of the study is to evaluate the effects on motor and cognitive performance of transcranial alternating current stimulation (tACS) compared to transcranial direct current stimulation (tDCS) and placebo stimulation (sham) in patients with neurodegenerative ataxia to identify a possible rehabilitation protocol.
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
研究组 & 干预措施
Transcranial direct current stimulation (tDCS)
Single session of anodal tDCS at 2 mA over the cerebellar hemispheres
干预措施: Transcranial stimulation over the cerebellar hemispheres (Device)
Transcranial alternate current stimulation (tDCS)
Single session of gamma tACS (50 Hz) at 3 mA over the cerebellar hemispheres
干预措施: Transcranial stimulation over the cerebellar hemispheres (Device)
Placebo stimulation (sham)
Single session of sham tDCS over the cerebellar hemispheres
干预措施: Transcranial stimulation over the cerebellar hemispheres (Device)
结局指标
主要结局
Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline
时间窗: Baseline (immediately before the intervention) - Immediately after the intervention
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 (immediately before the intervention) - Immediately after the intervention
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 Timed Up and Go Test Duration From Baseline(Baseline (immediately before the intervention) - Immediately after the intervention)
- Change in Walking Cadence From Baseline(Baseline (immediately before the intervention) - Immediately after the intervention)
- Change in 360° Turn From Baseline(Baseline (immediately before the intervention) - Immediately after the intervention)
- Change in Cerebellar Brain Inhibition (CBI) Measurements From Baseline(Baseline (immediately before the intervention) - Immediately after the intervention)
研究者
Barbara Borroni
Professor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia