DBS and Respiration
- Conditions
- Parkinson Disease
- Interventions
- Device: DBS
- Registration Number
- NCT04058457
- Lead Sponsor
- University of Oxford
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description STN DBS DBS Patients planned to undergo deep brain stimulation of the subthalamic nucleus GPi DBS DBS Patients planned to undergo deep brain stimulation of the globus pallidus interna VIM DBS DBS Patients planned to undergo deep brain stimulation of the ventral intermediate nucleus of thalamus.
- Primary Outcome Measures
Name Time Method Change in breathlessness 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 Outcome Measures
Name Time Method 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 hypercapnic ventilatory response ON and OFF stimulation between 1 and 6 months after surgery Changes in ventilation from incrementally increased inhaled CO2
Change in daily activity Pre-operatively (10 days) and post-operatively (10 days within 6 months of surgery once recovered from surgery and programmed) Heart rate
Change in breath-hold ON and OFF stimulation between 1 and 6 months after surgery Dyspnoea threshold and breakpoint
Change in pulmonary function ON and OFF stimulation between 1 and 6 months after surgery Spirometry
Change in surface electromyography of respiratory muscles ON and OFF stimulation between 1 and 6 months after surgery Signal analysis for evidence of tremor
MRI structural connectivity Pre-operative scan with post-operative analysis through study completion at an average of 1 year DTI correlation with respiratory outcomes
Trial Locations
- Locations (1)
John Radcliffe Hospital
🇬🇧Oxford, Oxfordshire, United Kingdom