VOP/VIM Direct Electrical Stimulation Increases Motor Cortex Excitability and Motor Output
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Electromyography Activity
研究概览
简要总结
In this study the investigators aim to enroll patients scheduled to undergo deep brain stimulation (DBS) implantation for movement disorders for intra-operative testing. In addition to standard-of-care surgical procedure to implant deep brain stimulation electrode leads, participants will also be stimulated and recorded from cortical areas by a temporary strip electrode (1X6) in the subdural space. The electrodes will be connected to external stimulators and a series of experiments will be performed to assess effects of the DBS on movement quality and electrophysiology measures. Results of this study will elucidate the biological mechanisms related to deep brain stimulation in modulating motor and speech function in patients with abnormal movement disorders.
详细描述
In this study the investigators aim to enroll patients for intra-operative testing. Specifically, the investigators will recruit patients already undergoing DBS implantation for movement disorders. In addition to standard-of-care subcortical mapping using micro-electrode recording (MER) and macro-stimulation mapping during DBS placement, cortical local field potentials (LFPs) will be simultaneously recorded from primary motor (M1) and somatosensory (S1) cortical areas by placement of a temporary strip electrode (1X6) in the subdural space. Appropriate localization of this grid over M1 and S1 will be confirmed by the so-called phase-reversal of somatosensory evoked potentials (SSEPs). Once M1 is localized, the strip electrode over M1 will be used to produce motor evoked potentials to contralateral hand muscles from direct cortical stimulation (DCMEPs). The stimulation threshold of the DCMEPs will be used as a direct measure of the excitability of the cortical spinal tract and compared with and without stimulation of the VOP/VIM nuclei. Cortical and subcortical LFPs will be obtained alongside electromyographic (EMG) data while the patient performs contralateral upper extremity movement tasks measuring velocity, grip strength, and strength modulation and while the patient perform a variety of articulation exercises. Along with the DCMEP stimulation thresholds, these parameters of motor output will be obtained both with and without VOP/VIM stimulation to assess for stimulation induced potentiation of motor output.
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
- 否
入选标准
- •Essential tremor patients who are scheduled to undergo deep brain stimulation surgery at UPMC Presbyterian with asymmetric essential tremor symptoms will be included, with the tested limb corresponding to the least affected arm to better approximate normal function. These patients are implanted bilaterally regardless of symptom laterality, as the natural history of essential tremor indicates eventual bilateral symptoms.
- •Parkinson's Disease patients who are scheduled to undergo deep brain stimulation surgery at UPMC Presbyterian with a history of Parkinson's Disease will also be recruited for intra-operative stimulation of their STN-targeted implants, to assess if VIM/VOP has high specificity for improving motor output.
- •Confirmation that subjects' terms of insurance coverage for their standard of care procedure will not be altered by study enrollment.
排除标准
- •Patients will be excluded from the study if there is any seizure history, to avoid the increased epileptogenic risk of intraoperative stimulation.
- •Patients with significant bilateral tremor that precludes completion of motor tasks.
研究组 & 干预措施
Direct Cortical Stimulation and Deep Brain Stimulation of the Motor Thalamus
Individuals undergoing deep brain stimulation device implanted in the motor thalamus for movement disorders treatment. Some of whom may also sustain speech, swallowing, and motor deficits.
干预措施: Direct cortical stimulation and deep brain stimulation of motor thalamus (Device)
结局指标
主要结局
Electromyography Activity
时间窗: 14 days
The investigators will record electromyography activity (EMG) to measure the motor evoked potentials of upper limb and facial muscles. At the end of the procedures these needles and/or the superficial adhesive electrodes will be removed. Based on the preliminary data, the investigators will consider the number of participants with at least an 18% increase in muscle activation as minimally acceptable.
次要结局
- Facial Muscle Motor Function - Muscle Strength(14 days)
- Speech Intelligibility(14 days)
- Dexterity of Articulation AMRs(14 days)
- Dexterity of Articulation SMRs(14 days)
- Facial Muscle Motor Function - Range of Motion(14 days)
- Facial Muscle Motor Function - Muscle Strength(14 days)
- Facial Muscle Motor Function - Range of Motion(14 days)
- Speech Intelligibility(14 days)
- Dexterity of Articulation AMRs(14 days)
- Dexterity of Articulation SMRs(14 days)
研究者
Jorge Gonzalez-Martinez
Professor
University of Pittsburgh