DBS for Parkinson's (NCT04058457)
Brain stimulation changes breathing function
- Trial ID
- NCT04058457
- Official Title
- Deep Brain Stimulation in Parkinson's Disease: Respiratory Testing
- Goal
- Brain stimulation changes breathing function
- Status
- RECRUITING
- Sponsor
- University of Oxford
- Study Type
- OBSERVATIONAL
- Enrollment
- 60 participants
- Conditions
- Parkinson Disease
- Interventions
- DBS
Summary For Families
They're looking at whether deep brain stimulation changes breathing and other respiratory functions in people with Parkinson's, since stimulating brain regions that control movement can also affect swallowing, speech, and respiratory control. Participants scheduled for DBS will have breathing tests before and after surgery while staying on their usual Parkinson's medications, and DBS works by delivering targeted electrical pulses to specific brain areas to modify abnormal circuits that cause motor symptoms so researchers can observe any effects on respiration. Adults 18 and older who are fluent in English and planned for DBS surgery can join, while people who are pregnant, have an acute respiratory problem, or are in another trial that affects breathing are excluded; about 60 people will be enrolled.
Locations
- John Radcliffe Hospital, Oxford, Oxfordshire, United Kingdom
Frequently Asked Questions
- What is this trial testing?
- This trial is studying DBS. They're looking at whether deep brain stimulation changes breathing and other respiratory functions in people with Parkinson's, since stimulating brain regions that control movement can also affect swallowing, speech, and respiratory control. Participants scheduled for DBS will have breathing tests before and after surgery while staying on their usual Parkinson's medications, and DBS works by delivering targeted electrical pulses to specific brain areas to modify abnormal circuits that cause motor symptoms so researchers can observe any effects on respiration. Adults 18 and older who are fluent in English and planned for DBS surgery can join, while people who are pregnant, have an acute respiratory problem, or are in another trial that affects breathing are excluded; about 60 people will be enrolled.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 5 years and 4 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.
- How many visits does this trial involve?
- You will be assessed both before (pre-operative) and after (post-operative) your surgery, completing respiratory questionnaires and tests of respiratory interoception and function.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive); MRI scan (non-invasive); Questionnaires & surveys (non-invasive); Wearable / at-home monitoring (non-invasive). Confirm the full schedule with the study coordinator.