Parkinson Disease Clinical Trial
Official title:
Deep Brain Stimulation in Parkinson's Disease: Respiratory Testing
NCT number | NCT04058457 |
Other study ID # | 256825 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 1, 2021 |
Est. completion date | September 21, 2024 |
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | September 21, 2024 |
Est. primary completion date | July 21, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | John Radcliffe Hospital | Oxford | Oxfordshire |
Lead Sponsor | Collaborator |
---|---|
University of Oxford | Oxford Brookes University |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in breathlessness | Dyspnoea questionnaire (D12, MRC) | Pre-operatively and post-operatively (6-months) | |
Primary | Change in breathlessness | Breathlessness ratings (modified-Borg Scale) from experimentally induced breathlessness. 0 = none, 10 maximum. Reported every 15 seconds. | ON and OFF stimulation between 1 and 6 months after surgery | |
Secondary | Change in pulmonary function | Spirometry | ON and OFF stimulation between 1 and 6 months after surgery | |
Secondary | Change in airways resistance | Oscillometry | ON and OFF stimulation between 1 and 6 months after surgery | |
Secondary | Change in respiratory muscle strength | Maximum inspiratory/expiratory pressures | ON and OFF stimulation between 1 and 6 months after surgery | |
Secondary | Change in surface electromyography of respiratory muscles | Signal analysis for evidence of tremor | ON and OFF stimulation between 1 and 6 months after surgery | |
Secondary | Change in hypercapnic ventilatory response | Changes in ventilation from incrementally increased inhaled CO2 | ON and OFF stimulation between 1 and 6 months after surgery | |
Secondary | Change in breath-hold | Dyspnoea threshold and breakpoint | ON and OFF stimulation between 1 and 6 months after surgery | |
Secondary | Change in daily activity | Pedometry | Pre-operatively (10 days) and post-operatively (10 days, within 6 months of surgery once recovered from surgery and programmed) | |
Secondary | Change in daily activity | Heart rate | Pre-operatively (10 days) and post-operatively (10 days within 6 months of surgery once recovered from surgery and programmed) | |
Secondary | MRI structural connectivity | DTI correlation with respiratory outcomes | Pre-operative scan with post-operative analysis through study completion at an average of 1 year |
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