跳至主要内容
临床试验/NCT01809613
NCT01809613已完成不适用

Functional Magnetic Resonance Imaging (fMRI) During Deep Brain Stimulation (DBS) to Treat Parkinson's Disease

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
88
试验地点
1
主要终点
Mean Score on Unified Parkinson's Disease Rating Scale (UPDRS)

研究概览

简要总结

This study is investigating the usefulness of using functional magnetic resonance imaging (fMRI) to monitor brain activation during deep brain stimulation for Parkinson's Disease, Essential tremor, dystonia, OCD, depression, pain, Tourette's syndrome, and epilepsy. The study may determine the relationship between patterns of brain activation and therapeutic outcome and/or side effects.

详细描述

Deep brain stimulation (DBS) is an effective neurosurgical approach for treating motor disorders including Parkinson's disease (PD), Essential Tremor (ET), and dystonia. Its therapeutic benefit has led to the application of DBS to a wide spectrum of disorders including psychiatric conditions, epilepsy, Alzeimer's disease, headache, obsessive-compulsive disorder (OCD), Tourette syndrome, depression and intractable pain. However, because the nature of its underlying mechanisms and clinical effects are not fully understood, precision targeting, decreasing adverse effects, and improving clinical outcomes represent major clinical and scientific challenges in PD and other disorders treated by DBS. Our goal is to investigate the inter-relationships between site-specific neural activation and clinical outcomes during DBS. To do so, we will perform non-invasive functional Magnetic Resonance Imaging (fMRI) to investigate DBS-mediated activation of neural network circuitry. Our proposed protocol involves the addition of intraoperative fMRI to the standard DBS or battery change protocol in order to determine the major sites of activation during application of clinically effective DBS to the subthalamic nucleus (STN), ventral intermediate thalamus (VIM), globus pallidus interna (GPi), fornix, nucleus accumbens (NAc), anterior thalamus and periaqueductal gray matter. Patients will undergo clinical assessment to determine the relative efficacy of DBS stimulation parameters, applied during the fMRI and at regularly scheduled post-operative programming visits up to 6 months of follow-up. Our Specific Aims are to: (1) Identify fMRI-activated brain regions by DBS in patients who undergo DBS surgery (Patients diagnosed with PD, ET, dystonia, OCD, depression, pain, Tourette's syndrome, and epilepsy. (2) Correlate fMRI activation with clinical outcomes and side effects. With the goal of improving DBS electrode targeting for optimal and reproducible clinical outcomes, these experiments will be the first attempt to relate site-specific DBS with functional in vivo imaging data and quantitative longitudinal clinical outcome measures in DBS patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult Patients with medically intractable Parkinson's Disease who have been approved for DBS surgery by the interdisciplinary Mayo DBS committee.

排除标准

  • Pregnant patients, prisoners, children (age less than 18), and any patients identified as unsuitable for this protocol by the Mayo DBS committee.

结局指标

主要结局

Mean Score on Unified Parkinson's Disease Rating Scale (UPDRS)

时间窗: 6 months after Deep Brain Stimulation

The UPDRS is a rating scale used to follow the longitudinal course of Parkinson's disease. The version of the scale used in this study has a total of 14 items; each of these item has a scale of 0-4, with 0 being no impairment, and 4 being severe impairment. All of the parts are combined to give a numeric score: 0 indicating no sign of disease, and 56, the highest score indicating severely incapacitated.

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kendall H. Lee

PI

Mayo Clinic

研究点 (1)

Loading locations...

相似试验