Elucidating the Temporality of Structural and Functional Connectivity Changes in Essential Tremor After Successful Deep Brain Stimulation to the Dentato-rubro-thalamic Tract
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Structural connectivity as indicated by fractional anisotropy (FA) as measured by diffusion tensor imaging (DTI) MRI
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Deep Brain Stimulation(DBS)
干预措施: Deep Brain Stimulation (Device)
结局指标
主要结局
Structural connectivity as indicated by fractional anisotropy (FA) as measured by diffusion tensor imaging (DTI) MRI
时间窗: 24 months after start of DBS
Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)
时间窗: During DBS placement surgery during active DBS
10 items are measured-each is scored from 0-4,higher number indicating more tremor
Structural connectivity as indicated by mean diffusivity as measured by diffusion tensor imaging (DTI) MRI
时间窗: 24 months after start of DBS
Spectral power recorded during intraoperative electrocorticography (ECoG)
时间窗: During DBS placement surgery during active DBS
Structural connectivity as indicated by axial diffusivity as measured by diffusion tensor imaging (DTI) MRI
时间窗: 24 months after start of DBS
Functional connectivity as indicated by blood oxygen level dependent (BOLD) signal as measured by resting state functional MRI (rsfMRI)
时间窗: 72 hours after DBS is turned off
Structural connectivity as indicated by radial diffusivity as measured by diffusion tensor imaging (DTI) MRI
时间窗: 24 months after start of DBS
Structural connectivity as indicated by fractional anisotropy (FA) as measured by diffusion tensor imaging (DTI) MRI
时间窗: Baseline before DBS implant
Structural connectivity as indicated by mean diffusivity as measured by diffusion tensor imaging (DTI) MRI
时间窗: Baseline before DBS implant
Structural connectivity as indicated by radial diffusivity as measured by diffusion tensor imaging (DTI) MRI
时间窗: Baseline before DBS implant
Structural connectivity as indicated by axial diffusivity as measured by diffusion tensor imaging (DTI) MRI
时间窗: Baseline before DBS implant
Functional connectivity as indicated by blood oxygen level dependent (BOLD) signal as measured by resting state functional MRI (rsfMRI)
时间窗: Baseline before DBS implant
Functional connectivity as indicated by blood oxygen level dependent (BOLD) signal as measured by resting state functional MRI (rsfMRI)
时间窗: 24 months after start of DBS
Functional connectivity as indicated by blood oxygen level dependent (BOLD) signal as measured by resting state functional MRI (rsfMRI)
时间窗: Baseline before DBS is turned off
Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)
时间窗: Baseline before DBS implant
10 items are measured-each is scored from 0-4,higher number indicating more tremor
Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)
时间窗: 24 months after start of DBS
10 items are measured-each is scored from 0-4,higher number indicating more tremor
Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)
时间窗: Baseline before DBS is turned off
10 items are measured-each is scored from 0-4,higher number indicating more tremor
Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)
时间窗: 72 hours after DBS is turned off
10 items are measured-each is scored from 0-4,higher number indicating more tremor
Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)
时间窗: During DBS placement surgery before active DBS
10 items are measured-each is scored from 0-4,higher number indicating more tremor
Spectral power recorded during intraoperative electrocorticography (ECoG)
时间窗: During DBS placement surgery before active DBS
次要结局
- Tremor amplitude as assessed by accelerometric power(72 hours after DBS is turned off)
- Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA)(72 hours after DBS is turned off)
- Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA)(Baseline before DBS implant)
- Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA)(24 months after start of DBS)
- Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA)(Baseline before DBS is turned off)
- Tremor amplitude as assessed by accelerometric power(Baseline before DBS is turned off)