A Study on Cerebello-Spinal tPCS in Ataxia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in Ataxia rating scale
研究概览
简要总结
Neurodegenerative ataxia represents a group of disabling diseases. No effective treatment is currently available for them. Currently, studies are going on the effectiveness of noninvasive neurostimulation in neurodegenerative diseases. Transcranial pulsed current stimulation (tPCS) is a new modality of noninvasive neurostimulation. The investigators have planned to study the efficacy of tPCS in these patients of neurodegenerative ataxia.
Patients will be first examined clinically along with the rating of ataxia, assessment of upper limb coordination and speech as per protocol. Quantitative Electroencephalography (qEEG) and gait analysis will be done as per protocol. Next, a single session of 20 min non-invasive stimulation will be given via tPCS or sham stimulation. Stimulation will be given to cerebellum and dorsal spinal cord. After 20 mins of stimulation, re-assessment will be done using the same tools mentioned pre-stimulation.
详细描述
The investigators have planned to study the efficacy of cerebello-spinal stimulation via Transcranial pulsed current stimulation (tPCS) in patients of neurodegenerative ataxia. Anodal stimulation will be used for the cerebellum and cathodal stimulation for the dorsal cord.
Patients will be assessed clinically and by EEG, KinArm and Gait - before and after a single session of 20 min stimulation via tPCS or sham stimulation.
The investigators have planned to assess-
- Speech
- Upper limb ataxia via KinArm. Standard KinArm testing protocol will be used which is used universally.
- Gait via Gait Carpet
- EEG
- Scale for the assessment and rating of ataxia (SARA)
tPCS will be delivered through a pair of saline-soaked (0.9% NaCl) surface sponge electrodes (7 × 5 cm2, for the anodal cerebellar electrode; 8 × 6 cm2 for the cathodal spinal electrode). Anode will be placed on the scalp over the cerebellum area (2 cm under the inion). Cathode will be placed over the dorsal cord. Stimulation will be given for 20 mins.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed as neurodegenerative ataxia clinically or by genetic study.
排除标准
- •Patients who can't walk even with support, like wheel chair bound patients.
- •Patients having other issues like stroke that can aggravate speech/ gait.
- •Patients who are not able to provide informed consent.
- •Patients who are unable to communicate by speech and who can't comprehend the English language.
研究组 & 干预措施
Real tPCS
Patients of degenerative ataxia will be randomly allocated into both the arms. Real tPCS arm will receive active tPCS. Then they will be crossed over to Sham tPCS arm.
干预措施: Active Transcranial pulsed current stimulation (tPCS) (Device)
Sham tPCS
Patients of degenerative ataxia will be randomly allocated into both the arms. Sham tPCS arm will receive sham tPCS. Then they will be crossed over to Real tPCS arm.
干预措施: Sham Transcranial pulsed current stimulation (tPCS) (Device)
结局指标
主要结局
Change in Ataxia rating scale
时间窗: 3 months
We will evaluate the effectiveness of tPCS in patients of neurodegenerative ataxia. We will apply Scale for the assessment and rating of ataxia (SARA) for rating of ataxia pre and post stimulation. The scale is for assessing severity of ataxia, that consists of assessment of gait, stance, sitting, speech, finger chase, finger to nose test, fast alternating hand movement, heel-shin test. By summing up, the total score ranges from minimum 0 and maximum 36. Higher score means more severity.
Change in speech
时间窗: 3 months
We will use standardized speech protocol pre and post stimulation to assess speech.
Change in upper limb co-ordination
时间窗: 3 months
We will use KinArm pre and post stimulation to have objective measurement of upper limb co-ordination.
Changes in spatiotemporal gait measures using objective gait analysis
时间窗: 3 months
We will use Zeno Walkway Gait carpet and the spatiotemporal details of the gait will be analyzed by ProtoKinetics Movement Analysis Software (PKMAS) software, pre and post stimulation.
Changes in Network fragmentation using Quantitative EEG
时间窗: 3 months
We will do network fragmentation by 5 mins of resting quantitative Electroencephalography (EEG), pre and post stimulation.
次要结局
未报告次要终点
研究者
Mandar Jog
Professor
Western University, Canada