NCT04058457

DBS and Respiration

Deep Brain Stimulation in Parkinson's Disease: Respiratory Testing

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	DBS	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.

Timeline

• Start date: 2021-04-01
• Primary completion: 2026-07-21
• Completion: 2026-09-21
• First posted: 2019-08-15
• Last updated: 2025-03-27

Locations

1 site across 1 country: United Kingdom