Deep Brain Stimulation in Parkinson's Disease: Respiratory Testing
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- University of Oxford
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in breathlessness
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Change in breathlessness
Time Frame: 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.
Secondary Outcomes
- 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)