Effects of Cerebellar Transcranial Direct Current Stimulation During Balance Training on Cerebellar Ataxia
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in balance
研究概览
简要总结
Cerebellar ataxia is a neurologic symptom caused by damage or dysfunction in the cerebellum and its pathways that results in loss of coordination, balance and postural control. There is a high rate (93%) of fallings for this population that could limit daily life activities. Pharmacological interventions are not able to modify the balance, therefore, new approaches to rehabilitate must be studied. ctDCS is a non-invasive brain stimulation that seems to be a new and innovator technique to restore ataxia symptoms. The purpose of this study is to evaluate the effects of ctDCS associated with balance training on cerebellar ataxia patients. A counterbalanced crossover, sham-controlled, triple blind trial will be performed. All subjects will receive the real and sham ctDCS associated to balance training. The anodal ctDCS (2 mA, 20 minutes) or sham (2mA, 30 seconds) will be applied during balance training at Biodex Balance System (BBS). The balance will be the primary outcome and will be evaluated through Posture Control at Biodex Balance System. Ataxia' severity and functional mobility will be the secondary outcomes and will be evaluated by the scale for the assessment and rating of ataxia (SARA) and 10 meters walking test, respectively.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Cerebellar ataxia
- •Score > 1 ≤ 4 on posture of Scale for assessment and rating of ataxia
排除标准
- •Individuals with other neurological disorders, postural hypotension, vestibular, visual, cardiovascular or musculoskeletal disorders that affect the performance of the proposed tests;
- •Pacemaker;
- •History of seizures;
- •Metallic implants in the head or neck;
- •Medication change (3 months) during the period of study
研究组 & 干预措施
ctDCS sham during Balance training
干预措施: Sham cerebellar transcranial direct current stimulation (Device)
ctDCS sham during Balance training
干预措施: Balance training (Other)
ctDCS during Balance training
干预措施: cerebellar transcranial direct current stimulation (Device)
ctDCS during Balance training
干预措施: Balance training (Other)
结局指标
主要结局
Change in balance
时间窗: 5 minutes before the intervention and 10 minutes after the intervention
The change in balance will be assessed through postural control index of Biodex Balance System. This postural control index is a continuous variable where lower index means less instability and better balance.
次要结局
- Change in Ataxia' severity(10 minutes before the intervention and 15 minutes after the intervention)
- Change in functional mobility(15 minutes before the intervention and 20 minutes after the intervention)
研究者
Kátia Monte-Silva
Study director
Universidade Federal de Pernambuco