Cerebellar Deep Brain Stimulation for the Treatment of Refractory Ataxia and Gait Disorders: Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Incidence of DBS surgical complications defined by the CTCAE (2017)
研究概览
简要总结
Abnormal gait is often associated with immobility and falls, which in turn lead to loss of functional independence and death. While gait disorders may arise from many different etiologies, dysfunction of the cerebellum (a part of the brain with the function of coordination of movement) leading to gait disorders results in distinct features. Gait ataxia is a specific type of neurological gait disorder and is defined as the presence of abnormal, uncoordinated movements associated with gait. To date, there are limited treatments for ataxia and/or gait disorders. Deep brain stimulation (DBS) is a neurosurgical tool that has been widely used for over twenty years, mainly to treat Parkinson's disease, dystonia, and essential tremor. In this study, we aim to implant DBS in patients with ataxia and/or gait disorder in the cerebellum area, and electrically stimulate them in a titratable and ultimately reversible manner. This study is divided into 3 phases: pre-operative, operative and post-operative phase. The purpose of this pilot study is to evaluate the safety, feasibility, and to validate the DBS of cerebellar cortical and deep nuclei in patients with treatment refractory ataxia. Twelve(12 ) patients will be enrolled in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Female or Male patients between age 20-70
- •Diagnosis of primary ataxia (inclusive of congenital and hereditary subtypes without other neurological compromise)
- •Head CT scan and cerebral MRI without any structural contraindications for safe DBS
- •Patient able to give written consent
- •Able to comply with all testing, follow-ups and study appointments and protocols
排除标准
- •Active neurologic disease including but not limited to epilepsy and certain brain tumors
- •Secondary ataxia (such as due to stroke, medication, autoimmune disease, ischemia, tumor, or other lesion)
- •Any contraindication to MRI scanning
- •Likely to relocate or move during the study's one-year duration
- •Presence of cardiac arrhythmias, or other cardiac, respiratory, renal or endocrine conditions that will result in significant risk from a surgical procedure.
研究组 & 干预措施
Neurosurgery
Standard of Care Neurosurgery for new indication
干预措施: Deep Brain Stimulation (Device)
结局指标
主要结局
Incidence of DBS surgical complications defined by the CTCAE (2017)
时间窗: Surgical complication will assessed and recorded at 2 week , 1Month, 2Month, 3Month, 4 Month, 5Month, 6Month, 8Month, 10Month and 12 Month post OP
The overall incidence of surgical complications will be documented and used as a safety parameter. Published complication rates for DBS surgery are between 4% to 30%, with an overall mean of 16% . Therefore, to be considered a safe treatment, incidence should not be higher than 30%. Surgical complication will be defined according to the CTCAE, documenting the cases of grade 2 to 5 (CTCAE, 2017).
次要结局
- Improvement in Scale for the Assessment and Rating of Ataxia (SARA) over 1 year post DBS surgery(The SARA scale will be assessed under both Stimulation ON and Stimulation OFF condition at- 2 week , 1Month, 2Month, 3Month, 4 Month, 5Month, 6Month, 8Month, 10Month and 12 Month post OP)
研究者
Suneil Kalia
Principal Investigator
University Health Network, Toronto