RecruitingRecruiting
DBS and Respiration
NCT04058457 · University of Oxford
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Deep Brain Stimulation in Parkinson's Disease: Respiratory Testing
About this study
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.
Eligibility criteria
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
Study design
Enrollment target: 60 participants
Age groups: adult, older_adult
Timeline
Starts: 2021-04-01
Estimated completion: 2026-09-21
Last updated: 2025-03-27
Interventions
Device: DBS
Primary outcomes
- • Change in breathlessness (Pre-operatively and post-operatively (6-months))
- • Change in breathlessness (ON and OFF stimulation between 1 and 6 months after surgery)
Sponsor
University of Oxford · other
With: Oxford Brookes University
Contacts & investigators
ContactAlex Green, FRCS · contact · alex.green@nds.ox.ac.uk · 01865227645
InvestigatorAlex Green, FRCS · principal_investigator, University of Oxford
All locations (1)
John Radcliffe HospitalRecruiting
Oxford, Oxfordshire, United Kingdom