Deep Brain Stimulation in Parkinson's Disease: Respiratory Testing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in breathlessness
研究概览
简要总结
Patients referred to neurosurgery routinely and safely undergo deep brain stimulation (DBS) for treatment of neurological conditions, most commonly Parkinson's disease.
The investigators have observed that respiratory problems (breathlessness) sometimes occur subsequent to DBS of the subthalamic nucleus (STN). This study aims to determine whether this is indeed a consequence of STN stimulation. Secondary objectives include identification of the respiratory physiological mediators of any interoceptive neuromodulation observed, changes in daily physical activity and MRI structural connectivity analysis.
详细描述
A continuous cohort of Parkinson disease patients planned to undergo STN-DBS will be approached to participate in this study (i.e. every patient will be offered participation in the study). Over the same time period other DBS patients (GPi and VIM) will be approached before their implantation procedure to participate as controls/comparators. Participants will all be offered the full study, but will also be free to participate in a smaller number of activities if so chosen.
Patients will be assessed both pre-operatively and post-operatively where they will complete a compound respiratory questionnaire and tests of respiratory interoception and function. Post-operatively, these tests will be carried out with stimulation ON and OFF, the order of which will be randomised between patients.
Data on daily activity will be collected during pre- and post-operative windows, using a wearable pedometer/heart-rate monitor.
Positive findings of respiratory neuromodulation will be correlated between patients with structural connectivity (e.g. STN-insula.) from pre-operative MRI scans.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Participant is willing and able to give informed consent for participation in the study.
- •Male or female, aged 18 years or above.
- •Planned for required DBS surgery
- •Fluent in the English language
- •For experimental group: diagnosed with Parkinson's disease
排除标准
- •Female who is pregnant
- •Subject is currently participating in a clinical investigation that includes an active treatment arm which may affect the respiratory system.
- •Acute respiratory problem at time of experimental session: e.g. rhinosinusitis, pharyngitis, asthma exacerbation
结局指标
主要结局
Change in breathlessness
时间窗: ON and OFF stimulation between 1 and 6 months after surgery
Breathlessness ratings (modified-Borg Scale) from experimentally induced breathlessness. 0 = none, 10 maximum. Reported every 15 seconds.
次要结局
- Change in respiratory muscle strength(ON and OFF stimulation between 1 and 6 months after surgery)
- Change in airways resistance(ON and OFF stimulation between 1 and 6 months after surgery)
- Change in hypercapnic ventilatory response(ON and OFF stimulation between 1 and 6 months after surgery)
- Change in daily activity(Pre-operatively (10 days) and post-operatively (10 days within 6 months of surgery once recovered from surgery and programmed))
- Change in breath-hold(ON and OFF stimulation between 1 and 6 months after surgery)
- Change in pulmonary function(ON and OFF stimulation between 1 and 6 months after surgery)
- Change in surface electromyography of respiratory muscles(ON and OFF stimulation between 1 and 6 months after surgery)
- MRI structural connectivity(Pre-operative scan with post-operative analysis through study completion at an average of 1 year)