Chronic Effects of Deep Brain Stimulation on Cortical Local Field Potentials in Parkinson's Disease and Dystonia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Number of Patients With Parkinson's Disease With Reliable Cortical and Sub-cortical Brain Signals
研究概览
简要总结
The purpose of this study is to use an investigational device to record brain activity for 12-24 months following surgical implantation of deep brain stimulation (DBS) systems. The goal of the study is better understanding of brain activity in movement disorders and how they relate to DBS, not to bring new devices to market.
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
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(both groups):
- •Ability to give informed consent for the study
- •Movement disorder symptoms that are sufficiently severe, in spite of best medical therapy, to warrant surgical implantation of deep brain stimulators according to standard clinical criteria
- •Inclusion criteria (Isolated dystonia):
- •Age 22-75
- •Isolated dystonia that is generalized or segmental, that must affect one or - Stable doses of anti-dystonia medications (such as Artane, Baclofen, or Clonopin) for at least 30 days prior to baseline assessment
- •For patients with craniofacial involvement, prior treatment with botulinum toxin with failure to adequately control dystonia symptoms.
- •Inclusion criteria (PD):
- •Age 30-75
- •Bilateral disease (Hoehn and Yahr stage 2 or greater)
- •Has been treated with levodopa/carbidopa, and with a dopamine agonist, at the maximal tolerated doses as determined by a movement disorders neurologist
- •Stable doses of antiParkinsonian medications for at least 30 days prior to their baseline assessment
- •Significant disability in the setting of optimal medical management by a movement disorders neurologist. Disability may be due to tremor that is unresponsive to medications, or to motor fluctuations
- •UPDRS-III score off medication between 20 and 60
- •Improvement of at least 30% in the baseline UPDRS-III on medication score, compared to the baseline off-medication score.
排除标准
- •(both groups):
- •Pregnancy or breast feeding
- •MRI showing cortical atrophy out of proportion to age
- •MRI showing focal brain lesions that could indicate a non-idiopathic movement disorder,
- •Major comorbidity increasing the risk of surgery (prior stroke, severe hypertension, severe diabetes, or need for chronic anticoagulation other than aspirin)
- •Inability to comply with study follow-up visits
- •Any prior intracranial surgery
- •Mood depression with a Beck depression inventory score of > 17 on baseline screening
- •Significant cognitive impairment (MoCA<25).
- •History of seizures
- •Immunocompromised
- •Has an active infection
- •Requires diathermy, electroconvulsive therapy (ECT) or transcranial magnetic - Has an implanted electronic device such as a neurostimulator, cardiac pacemaker or medication pump.
研究组 & 干预措施
chronic brain recording
This is a one-arm, single-center study of the neurophysiology of human movement disorders with two goals: 1) Assess the feasibility of chronic brain recording using a novel fully implantable pulse generator (Medtronic Activa PC+S), which has the capability of sensing and storing local field potentials (LFPs) recorded from implanted electrodes, in addition to providing therapeutic deep brain stimulation (DBS). 2) Study acute and chronic effects of therapeutic DBS on cortical LFPs. 3) Study feasibility of the use of brain signals as feedback either directly to the patient or for DBS stimulation adjustments.
干预措施: Activa PC+S (Device)
结局指标
主要结局
Number of Patients With Parkinson's Disease With Reliable Cortical and Sub-cortical Brain Signals
时间窗: 24 months
To report number of PD patients with reliable cortical and subcortical brain signal recorded using Activa PC+S.
次要结局
未报告次要终点
研究者
Philip Starr
Professor, Neurological Surgery
University of California, San Francisco