3T MRI in Patients With Deep Brain Stimulation (DBS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Brain areas engaged with deep brain stimulation
研究概览
简要总结
Deep brain stimulation (DBS) is an established treatment for advanced Parkinson's disease, medically refractory tremor, dystonia and obsessive compulsive disorder. Several hypotheses driven DBS trials are underway to study modulation of circuit dysfunction in other neurological and psychiatric disorders like epilepsy, Alzheimer's disease and depression. Recent reports suggest profound effects of DBS on the anatomy and function of downstream areas in the brain. For example electrical stimulation of limbic circuits is associated with increase in hippocampal neurogenesis. Similarly, stimulation of subthalamic nucleus (STN) or globus pallidus (GPi) results in activation of cortical motor circuits. Non-invasive imaging modalities are increasingly being employed in these investigations to better understand the effects of DBS on the structure and function of the brain.
There have been important advances in MRI and we now have MRI which provides higher resolution and higher quality brain images. More specifically, the investigators propose to use MRI to perform functional magnetic resonance imaging (i.e. fMRI) to assess the effects of deep brain stimulation on brain function and to assess whether fMRI can be used as an adjunct to improve clinical practice in these patients.
详细描述
This is a prospective cohort study that will enroll patients who are about to or have already undergone DBS electrode placement for a variety of disorders including, but not limited to Parkinson's disease, essential tremor, dystonia, depression, epilepsy, neuropathic pain and Alzheimer's disease. This eligible patient population is broad but unified by the fact that they will all undergo DBS to treat specific circuit dysfunctions. Pre-operative DBS patients and patients with externalized leads or internalized IPG may be included.
We propose to study patients with externalized leads or internalized IPG programmed at either 'switched off' (IPG at 0 volt and off state) and 'switched on' settings We have already performed phantom safety testing for these experimental conditions and found it to be safe. We propose to perform the following scans:
- Structural 1.5Tesla or 3Tesla MRI with 8 channel coil/or transmit-receive head coil - 3D FSPGR, standard FRFSE T2 scan, standard DTI scan (white matter tracts) and standard QSM (Quantitative Susceptibility Mapping) scan (Iron quantification).
- Resting state and task based functional MRI with 8 channel coil
Further, we propose to assess whether the aforementioned scans can be used as an adjunct to improve current DBS post-operative follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Age between 18 and 85 years of age
- •Participants must be planned to undergo, or have undergone implantation of DBS electrodes
- •Participants must be able to understand the purpose of this research and must sign the informed consent form.
- •Participants must understand that the role of this research is to enhance our understanding of brain functioning and that he/she will not directly or indirectly benefit from the study.
排除标准
- •Participants who have serious cognitive or psychological impairments and cannot give informed consent.
- •Participants who are unable to effectively or efficiently communicate, for example patients suffering from speech deficits (dysarthria, aphasia) or are non-English speaking.
研究组 & 干预措施
fMRI-based programming
DBS patients will undergo fMRI scanning while on different stimulation settings. The results will be fed to the programming clinician (movement disorder neurologist) to aid the conventional programming process at the clinician's discretion.
干预措施: fMRI (Other)
结局指标
主要结局
Brain areas engaged with deep brain stimulation
时间窗: 3 months before DBS implant to 1 year after DBS implant.
The primary outcome of interest is safety of 3T structural and functional brain MRI scans in patients with implanted DBS.
次要结局
- Structural connectivity using 1.5T or 3T MRI(3 months before DBS implant to 1 year after DBS implant.)
- Clinical outcome(3 months before DBS implant to 1 year after DBS implant.)
- Functional connectivity using 1.5T or 3T MRI(3 months before DBS implant to 1 year after DBS implant.)
研究者
Andres M. Lozano
Neurosurgeon
University Health Network, Toronto