阐明对 Dentato-rubro-丘脑束成功进行脑深部刺激后特发性震颤的结构和功能连接变化的时间性
The purpose of this study is to elucidate the structural connectivity of the dentato-rubro-thalamic tract (DRTt) and to detect functional network changes due to DRTt stimulation
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Mark Amandola
- 电话号码:516 491 1054
- 邮箱:mamandola@northwell.edu
学习地点
-
-
New York
-
Manhasset、New York、美国、11030
- 招聘中
- North Shore University Hospital
-
接触:
- Albert Fenoy
-
副研究员:
- Prashin Unadkat
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- the diagnosis of Essential Tremor, made by a movement disorder neurologist, where tremor is not secondary to any disease process or traumatic insult
- distal appendicular tremor, with minimal proximal component
- tremor refractory to multiple medication regimens and/or where the medications cause intolerable side effects
- tremor judged to be severely impacting their quality of life.
Exclusion Criteria:
- significant neurological disorder
- significant dementia or neurocognitive limitations as assessed by neuropsychiatry (when necessary)
- severe psychiatric illness with suicidal ideations
- previous surgery to destroy the target region of the brain
- surgical contraindications to DBS
- current major medical problems that affect brain anatomy,neurochemistry, or function, e.g., liver insufficiency, kidney insufficiency, cardiovascular problems, systemic infections, cancer, hypothyroidism, auto-immune diseases, and any current of history of brain disorder (seizure disorder, stroke, dementia, meningitis, encephalitis, degenerative neurologic diseases and head injury with loss of consciousness for any period of time)
- family history of hereditary neurologic disorder, besides essential tremors ET
- floating metallic objects in the body
- pregnancy
- alcohol or substance abuse/dependence in the past 6 months.
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:深部脑刺激 (DBS)
|
Medtronic Activa device will be implanted and administered clinically, except as part of the trial after 24 months of DBS being on it will be turned off for 3 days and will be turned back on. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
通过弥散张量成像 (DTI) MRI 测量的分数各向异性 (FA) 指示的结构连通性
大体时间:DBS 植入前的基线
|
DBS 植入前的基线
|
|
|
通过弥散张量成像 (DTI) MRI 测量的分数各向异性 (FA) 指示的结构连通性
大体时间:DBS 开始后 24 个月
|
DBS 开始后 24 个月
|
|
|
通过弥散张量成像 (DTI) MRI 测量的平均弥散系数表示的结构连通性
大体时间:DBS 植入前的基线
|
DBS 植入前的基线
|
|
|
通过弥散张量成像 (DTI) MRI 测量的平均弥散系数表示的结构连通性
大体时间:DBS 开始后 24 个月
|
DBS 开始后 24 个月
|
|
|
通过扩散张量成像 (DTI) MRI 测量的径向扩散率指示的结构连通性
大体时间:DBS 植入前的基线
|
DBS 植入前的基线
|
|
|
通过扩散张量成像 (DTI) MRI 测量的径向扩散率指示的结构连通性
大体时间:DBS 开始后 24 个月
|
DBS 开始后 24 个月
|
|
|
通过扩散张量成像 (DTI) MRI 测量的轴向扩散率指示的结构连通性
大体时间:DBS 植入前的基线
|
DBS 植入前的基线
|
|
|
通过扩散张量成像 (DTI) MRI 测量的轴向扩散率指示的结构连通性
大体时间:DBS 开始后 24 个月
|
DBS 开始后 24 个月
|
|
|
通过静息状态功能 MRI (rsfMRI) 测量的血氧水平依赖性 (BOLD) 信号指示的功能连通性
大体时间:DBS 植入前的基线
|
DBS 植入前的基线
|
|
|
通过静息状态功能 MRI (rsfMRI) 测量的血氧水平依赖性 (BOLD) 信号指示的功能连通性
大体时间:DBS 开始后 24 个月
|
DBS 开始后 24 个月
|
|
|
通过静息状态功能 MRI (rsfMRI) 测量的血氧水平依赖性 (BOLD) 信号指示的功能连通性
大体时间:DBS 关闭前的基线
|
DBS 关闭前的基线
|
|
|
通过静息状态功能 MRI (rsfMRI) 测量的血氧水平依赖性 (BOLD) 信号指示的功能连通性
大体时间:DBS 关闭后 72 小时
|
DBS 关闭后 72 小时
|
|
|
术中皮层脑电图 (ECoG) 期间记录的频谱功率
大体时间:在活动 DBS 之前的 DBS 放置手术期间
|
在活动 DBS 之前的 DBS 放置手术期间
|
|
|
术中皮层脑电图 (ECoG) 期间记录的频谱功率
大体时间:在 DBS 放置手术期间 在活动 DBS 期间
|
在 DBS 放置手术期间 在活动 DBS 期间
|
|
|
Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)
大体时间:Baseline before DBS implant
|
10 items are measured-each is scored from 0-4,higher number indicating more tremor |
Baseline before DBS implant
|
|
Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)
大体时间:24 months after start of DBS
|
10 items are measured-each is scored from 0-4,higher number indicating more tremor |
24 months after start of DBS
|
|
Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)
大体时间:Baseline before DBS is turned off
|
10 items are measured-each is scored from 0-4,higher number indicating more tremor |
Baseline before DBS is turned off
|
|
Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)
大体时间:72 hours after DBS is turned off
|
10 items are measured-each is scored from 0-4,higher number indicating more tremor |
72 hours after DBS is turned off
|
|
Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)
大体时间:During DBS placement surgery before active DBS
|
10 items are measured-each is scored from 0-4,higher number indicating more tremor |
During DBS placement surgery before active DBS
|
|
Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)
大体时间:During DBS placement surgery during active DBS
|
10 items are measured-each is scored from 0-4,higher number indicating more tremor |
During DBS placement surgery during active DBS
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
通过加速度计功率评估的震颤幅度
大体时间:DBS 关闭前的基线
|
DBS 关闭前的基线
|
|
|
通过加速度计功率评估的震颤幅度
大体时间:DBS 关闭后 72 小时
|
DBS 关闭后 72 小时
|
|
|
Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA)
大体时间:Baseline before DBS implant
|
It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia). |
Baseline before DBS implant
|
|
Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA)
大体时间:24 months after start of DBS
|
It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia). |
24 months after start of DBS
|
|
Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA)
大体时间:Baseline before DBS is turned off
|
It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia). |
Baseline before DBS is turned off
|
|
Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA)
大体时间:72 hours after DBS is turned off
|
It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia). |
72 hours after DBS is turned off
|
合作者和调查者
调查人员
- 首席研究员:Albert J Fenoy, MD、Northwell Health
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.