跳至主要内容
临床试验/NCT02278406
NCT02278406已完成不适用

Employing Near Infrared Spectroscopy to Non-invasively Assess Changes in Cerebral Perfusion in Response to Subthalamic Deep Brain Stimulation

Beth Israel Deaconess Medical Center2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
2
主要终点
Brain oxygen levels

研究概览

简要总结

The purpose of this study is to determine if deep brain stimulation can change brain oxygen levels in people with Parkinson's Disease. Measurements will be taken using a non-invasive device while subjects are both on and off their medications, and while their stimulator is in the on and off setting.

详细描述

The investigators will study the effects of electrical stimulation at the subthalamic nucleus on frontal cerebral perfusion in 10 patients with advanced PD who have already undergone successful STN DBS (Medtronic, Inc., Minneapolis, MN) surgery as evidenced by a 20% or greater improvement in their Unified Parkinson's disease rating scale (UPDRS) motor sub-score (UPDRS-III) with stimulation on vs off, three or more months after surgery. The UPDRS-III is a widely employed and validated rating scale of Parkinson's disease symptom severity that is based on the neurological examination. For the purposes of this study, a movement disorders neurologist will perform all of the neurological assessments. Patients must also be demonstrated to be cognitively intact as evidenced by a Montreal Cognitive Assessment (MoCA) Score of 24 or greater.

This is an experimental study in which we will compare frontal cerebral perfusion (measured non-invasively with the NIRS device) and UPDRS-III scores (as determined by neurological examination) in four clinical states: medications off/stimulation off; medication off/stimulation on; medication on/stimulation off; and medications on/stimulation on.

The primary question to be answered is: Can we detect significant changes in cerebral perfusion with the NIRS device in response to subthalamic stimulation delivered via implanted DBS devices?

This pilot study will be conducted in 10 PD patients who have undergone successful DBS surgery in the past. The study will be completed in one day as detailed below and will take about 6 hours to complete.

Patients will arrive to the movement disorders center on the morning of their scheduled study visit having discontinued their medications from the night before (12 hours 'off"). They will arrive with their stimulators on and set to the therapeutic parameters. Dr. Shih will perform a neurological examination and determine the UPDRS-III score in this, the off med/on stim state.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-75
  • Diagnosis of Idiopathic Parkinson's disease made by a movement disorders neurologist.
  • At least 3 months status-post bilateral subthalamic deep brain stimulation surgery
  • Positive response to STN DBS as evidenced by >20% improvement in UPDRS-III score after surgery as determined by a movement disorders neurologist.
  • Cognitively intact as demonstrated with a MOCA >
  • Signed informed consent.

排除标准

  • Failure to meet all of the inclusion criteria.

结局指标

主要结局

Brain oxygen levels

时间窗: 1 day

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ron Alterman

Professor of Neurosurgery

Beth Israel Deaconess Medical Center

研究点 (2)

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