John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU, United Kingdom
Location status: Recruiting
NCT Number: NCT04058457
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Oxford, Oxfordshire, OX3 9DU, United Kingdom
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Pre-operatively and post-operatively (6-months)
Dyspnoea questionnaire (D12, MRC)
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.
Time frame: ON and OFF stimulation between 1 and 6 months after surgery
Spirometry
Time frame: ON and OFF stimulation between 1 and 6 months after surgery
Oscillometry
Time frame: ON and OFF stimulation between 1 and 6 months after surgery
Maximum inspiratory/expiratory pressures
Time frame: ON and OFF stimulation between 1 and 6 months after surgery
Signal analysis for evidence of tremor
Time frame: ON and OFF stimulation between 1 and 6 months after surgery
Changes in ventilation from incrementally increased inhaled CO2
Time frame: ON and OFF stimulation between 1 and 6 months after surgery
Dyspnoea threshold and breakpoint
Time frame: Pre-operatively (10 days) and post-operatively (10 days, within 6 months of surgery once recovered from surgery and programmed)
Pedometry
Time frame: Pre-operatively (10 days) and post-operatively (10 days within 6 months of surgery once recovered from surgery and programmed)
Heart rate
Time frame: Pre-operative scan with post-operative analysis through study completion at an average of 1 year
DTI correlation with respiratory outcomes
Contact information is provided by the study sponsor or research team.
University of Oxford
Other
Deep Brain Stimulation in Parkinson's Disease: Respiratory Testing
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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