Long-term Stability of Local Field Potentials Recorded From the Subthalamic Nucleus and the Effects of Deep Brain Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Clinical measure of Parkinsonism: Unified Parkinson's disease rating scale
研究概览
简要总结
Movement disorders such as Parkinson Disease, dystonia, and tremor are related to abnormalities of part of the brain known as the basal ganglia. Recently, it has been suggested that the basal ganglia works by oscillations (group of neurons cycle between activation/deactivation when stimulated) of electrical signals. A treatment that involves insertion of electrodes in the subthalamic nucleus (STN) for electrical stimulation, known as deep brain stimulation (DBS), is an established treatment for advanced Parkinson's disease. However its mechanism of action is still not completely understood. Currently, DBS utilizes an "open loop" system whereby the stimulation settings are manually adjusted depending on the patients' clinical response.
- Determine whether the local field potential (LFP) recorded from the STN is stable over a 1.5 year period.
- Address whether STN LFP is a suitable control signal, and how it should be used to change DBS parameters
详细描述
Study Design and Methods
Ten Parkinson's disease (PD) patients who are scheduled for bilateral STN DBS will be recruited. DBS surgery will be performed at the Toronto Western Hospital as per standard clinical care. The studies will be performed at two sites: Toronto Western Hospital and London Mobility Laboratory at Western University. Recording of STN LFP using externalized DBS leads, the effects DBS at different frequencies on PD motor symptoms will be studied at the Toronto Western Hospital. Gait studies with full body kinematic measurements, recording of LFP and effects of different stimulation frequencies will be studied at the London Mobility Laboratory (LML) at Western University.
An outline of the study timeline is provided in Table (2, 3 and 4). Standardized tasks performed are provided in Table 5.Ten PD patients with bilateral DBS in STN will be studied for six visits to each site (TWH and LML). There will also be a presurgical baseline visit to LML. Patients will first be studied 1-3 days after DBS electrode implantation and before the implantation of the pulse generator. Local field potential (LFP) will be recorded from bilateral STN DBS electrodes using externalized leads. Following internalization of the DBS leads and insertion of the pulse generator (Activa PC+S, Medtronic), patients will be studied within 7 days for a second visit. DBS programming will be performed as per usual clinical practice. Patients will then be studied at 1, 2, 6, 12 and 18 months postoperatively.
Visits at the Toronto Western Hospital (TWH)
Visit 1 (TWH V1) This visit will obtain "acute" LFP recording for comparison to chronic recordings. Patients will be studied 1-3 days after electrode insertion when the leads are externalized. This is a two day visit, with one day in the off medication state (overnight withdrawal) and one day in the on medication state in random order. For the on medication state, 125% of the levodopa equivalent of the first morning preoperative dose will be administered to increase the chance of recording levodopa-induced dyskinesia.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PD Patients scheduled to undergo bilateral STN DBS surgery.
- •No previous brain surgery or other neurological disorders
- •No unstable medical conditions
- •Able to provide informed consent and comply with study protocol
排除标准
- •previous brain surgery or other neurological disorders unstable medical conditions
结局指标
主要结局
Clinical measure of Parkinsonism: Unified Parkinson's disease rating scale
时间窗: Through study completion, an average of 1.5 year
Clinical scales of Parkinson's disease will be measured using Unified Parkinson's disease rating scale at different time points (visits) of the study
次要结局
- Electrophysiologic measures of brain activity(Through study completion, an average of 1.5 year)
- Kinetic measures of walking(Through study completion, an average of 1.5 year)
研究者
Robert Chen
Senior Scientist and Professor of Medicine (Neurology)
University Health Network, Toronto