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临床试验/NCT04277689
NCT04277689Enrolling By Invitation不适用

Deep Neural Network Approaches for Closed-Loop Deep Brain Stimulation

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年6月10日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
30
试验地点
2
主要终点
The number of subjects providing interpretable electrophysiological data during DBS surgery

研究概览

简要总结

In this research study the researchers want to learn more about brain activity related to speech perception and production in patients with Parkinson's Disease who are undergoing deep brain stimulation (DBS).

详细描述

Deep brain stimulation (DBS) is the gold-standard treatment for patients with medication resistant motor complications of Parkinson's disease (PD) and provides the only opportunity to record and stimulate in the human basal ganglia. Most recently, the concurrent use of research electrocorticography (ECoG) during DBS surgery, including pioneering work from Pittsburgh, has further enabled basic neuroscience investigation of human cortical-subcortical network dynamics. The discovery that aberrant synchronization of rhythmic neuronal activity recorded in PD patients is suppressed by DBS has advanced the concept that measures associated with pathological activity may be used as biomarkers to control the delivery of DBS therapy. Pilot studies of aDBS in PD have reported promising clinical results from triggering DBS stimulation when the signal recorded from the DBS electrode showed a high level of oscillatory power in the beta frequency range (13 - 35 Hz). That approach, however, has important limitations. Most importantly, beta power recorded from the DBS lead is suppressed by movement including PD tremor, its detection is highly dependent on lead location and the recording montage needed to record during stimulation is incompatible with directional current steering, a recent innovation employing segmented stimulation contacts. The inherent complexity of the increased parameter space through DBS innovations also overwhelms standard programming techniques. Finally, use of additional biomarker signals (e.g., recorded from cortex) is likely to improve the ability to adaptively control DBS for disorders marked by complex multidimensional symptomatologies such as PD. The current proposal will establish methods for overcoming these limitations by developing techniques for multi-feature classification from ECoG recordings, using advanced machine learning algorithms.

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

入选标准

  • Subjects scheduled for DBS implantation, as determined by the clinical multidisciplinary movement disorders board with definitive diagnosis of Parkinson's disease
  • Subjects able to provide informed consent and comply with task instructions.
  • Subjects 18-85 years old

排除标准

  • 1. Non-English-speaking subjects

结局指标

主要结局

The number of subjects providing interpretable electrophysiological data during DBS surgery

时间窗: Duration of single DBS surgery

The number of subjects providing interpretable electrophysiological data during DBS surgery

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

Robert Mark Richardson

Director of Functional Neurosurgery at MGH

Massachusetts General Hospital

研究点 (2)

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