At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- DBS (device)
- How long the study runs
- Study runs about 65 months (dates as stated)
- About the drug or intervention
- DBS — device: Patients are tested pre-operatively and the post-operatively with their implanted neurostimulators ON and OFF.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 60
- Started
- 2021-04-01
- Last checked
- 2024-03
Plain English Summary
What is this study?
- • Testing a new treatment for parkinson disease
- • Clinical study - 60 participants
- • Patients referred to neurosurgery routinely and safely undergo deep brain stimulation (DBS) for treatment of neurological conditions, most commonly Parkinson's disease
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with parkinson disease
Where?
- • Oxford - John Radcliffe Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ DBS surgery
What the study is looking for
- ✓Participant is willing and able to give agreement to take part 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
Who cannot take part
- ✗Female who is pregnant
- ✗Subject is currently participating in a clinical investigation that includes an active treatment arm which may...
- ✗Acute respiratory problem at time of experimental session: e.g. rhinosinusitis, pharyngitis, asthma exacerbation
See the full criteria
Where Is This Study? (1 UK site)
John Radcliffe Hospital
Oxford OX3 9DU, United Kingdom
How to Get in Touch
Alex Green, FRCS
Sponsor contactCONTACT