| NCT ID | NCT04058457 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Oxford |
| Condition | Parkinson Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2021-04-01 |
| Primary Completion | 2026-07-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2021-04-01 with a primary completion date of 2026-07-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Alex Green, FRCS
PRINCIPAL INVESTIGATOR
University of Oxford
Frequently Asked Questions
Who can join the NCT04058457 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04058457 currently recruiting?
Yes, NCT04058457 is actively recruiting participants. Contact the research team at alex.green@nds.ox.ac.uk for enrollment information.
Where is the NCT04058457 trial being conducted?
This trial is being conducted at Oxford, United Kingdom.
Who is sponsoring the NCT04058457 clinical trial?
NCT04058457 is sponsored by University of Oxford. The principal investigator is Alex Green, FRCS at University of Oxford. The trial plans to enroll 60 participants.
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