Parkinson Disease
Conditions
Keywords
Parkinson disease, movement disorder, dyspnoea, dyspnea, breathlessness, respiratory
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.
Interventions
DEVICEDBS
Patients are tested pre-operatively and the post-operatively with their implanted neurostimulators ON and OFF. DBS implantation itself is part of routine care, and not part of the study.
Sponsors
Oxford Brookes University
University of Oxford
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in breathlessness | Pre-operatively and post-operatively (6-months) | Dyspnoea questionnaire (D12, MRC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in airways resistance | ON and OFF stimulation between 1 and 6 months after surgery | Oscillometry |
| Change in respiratory muscle strength | ON and OFF stimulation between 1 and 6 months after surgery | Maximum inspiratory/expiratory pressures |
| Change in surface electromyography of respiratory muscles | ON and OFF stimulation between 1 and 6 months after surgery | Signal analysis for evidence of tremor |
| Change in pulmonary function | ON and OFF stimulation between 1 and 6 months after surgery | Spirometry |
| Change in breath-hold | ON and OFF stimulation between 1 and 6 months after surgery | Dyspnoea threshold and breakpoint |
| Change in daily activity | Pre-operatively (10 days) and post-operatively (10 days, within 6 months of surgery once recovered from surgery and programmed) | Pedometry |
| MRI structural connectivity | Pre-operative scan with post-operative analysis through study completion at an average of 1 year | DTI correlation with respiratory outcomes |
| Change in hypercapnic ventilatory response | ON and OFF stimulation between 1 and 6 months after surgery | Changes in ventilation from incrementally increased inhaled CO2 |
Countries
United Kingdom
Contacts
Primary ContactAlex Green, FRCS
Outcome results
None listed