Understand brain control of breathing
- Trial ID
- NCT06074614
- Official Title
- Neural Control of Breathing in Parkinson's Disease: an Exploratory Study
- Goal
- Understand brain control of breathing
- Status
- RECRUITING
- Sponsor
- Radboud University Medical Center
- Study Type
- OBSERVATIONAL
- Enrollment
- 30 participants
- Conditions
- Parkinson Disease
- Interventions
- Hypercapnic ventilatory response, Respiratory related evoked potential, Transcranial magnetic stimulation
Summary For Families
The goal is to learn how Parkinson's affects the brain's control of breathing, which can help explain symptoms like a blunted response to rising carbon dioxide, cough or swallow problems, and breathlessness. The team will raise CO2 briefly to measure ventilatory drive, record electrical brain responses to breathing loads with respiratory related evoked potentials, and use noninvasive transcranial magnetic stimulation to activate motor brain areas and test how well respiratory pathways respond. Adults 18 and older are eligible, including people with Parkinson's at Hoehn and Yahr stages 1 to 3 and healthy volunteers, while people with other CNS diseases, major lung disease, implanted electronic or certain metal head devices, pregnancy, smoking, epilepsy or prior brain surgery are excluded.
Locations
- Radboudumc, Nijmegen, Gelderland, Netherlands
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Hypercapnic ventilatory response. The goal is to learn how Parkinson's affects the brain's control of breathing, which can help explain symptoms like a blunted response to rising carbon dioxide, cough or swallow problems, and breathlessness. The team will raise CO2 briefly to measure ventilatory drive, record electrical brain responses to breathing loads with respiratory related evoked potentials, and use noninvasive transcranial magnetic stimulation to activate motor brain areas and test how well respiratory pathways respond. Adults 18 and older are eligible, including people with Parkinson's at Hoehn and Yahr stages 1 to 3 and healthy volunteers, while people with other CNS diseases, major lung disease, implanted electronic or certain metal head devices, pregnancy, smoking, epilepsy or prior brain surgery are excluded.
- 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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 1 year and 6 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.