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.
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.
Study Type
OBSERVATIONAL
Enrollment
60
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.
John Radcliffe Hospital
Oxford, Oxfordshire, United Kingdom
RECRUITINGChange in breathlessness
Dyspnoea questionnaire (D12, MRC)
Time frame: Pre-operatively and post-operatively (6-months)
Change in breathlessness
Breathlessness ratings (modified-Borg Scale) from experimentally induced breathlessness. 0 = none, 10 maximum. Reported every 15 seconds.
Time frame: ON and OFF stimulation between 1 and 6 months after surgery
Change in pulmonary function
Spirometry
Time frame: ON and OFF stimulation between 1 and 6 months after surgery
Change in airways resistance
Oscillometry
Time frame: ON and OFF stimulation between 1 and 6 months after surgery
Change in respiratory muscle strength
Maximum inspiratory/expiratory pressures
Time frame: ON and OFF stimulation between 1 and 6 months after surgery
Change in surface electromyography of respiratory muscles
Signal analysis for evidence of tremor
Time frame: ON and OFF stimulation between 1 and 6 months after surgery
Change in hypercapnic ventilatory response
Changes in ventilation from incrementally increased inhaled CO2
Time frame: ON and OFF stimulation between 1 and 6 months after surgery
Change in breath-hold
Dyspnoea threshold and breakpoint
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Time frame: ON and OFF stimulation between 1 and 6 months after surgery
Change in daily activity
Pedometry
Time frame: Pre-operatively (10 days) and post-operatively (10 days, within 6 months of surgery once recovered from surgery and programmed)
Change in daily activity
Heart rate
Time frame: Pre-operatively (10 days) and post-operatively (10 days within 6 months of surgery once recovered from surgery and programmed)
MRI structural connectivity
DTI correlation with respiratory outcomes
Time frame: Pre-operative scan with post-operative analysis through study completion at an average of 1 year