Parkinson DiseaseNEURON-PDNCT06074614
Neural Control of Breathing in Parkinson's Disease
An observational study of Parkinson Disease, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Breathing is a complex process, which can be controlled through voluntary command or neural control. Parkinson's disease (PD) is a progressive neurological disorder. Many individuals with PD experience respiratory problems, such as coughing difficulties or shortness of breath. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Hypercapnic ventilatory response, Respiratory related evoked potential and Transcranial magnetic stimulation
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 Oct 2023to May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy participants: volunteers. Age- and sex-matched to the participants with Parkinson's disease. Participants with Parkinson's disease: recruited through the outpatient registry at the Radboud University Medical Center that have approved contact for research purposes.
Who may be able to join
- Healthy subjects: competent adult (>18 years) volunteers
- Patients: adult (<18 years) patients with Parkinson's disease, clinically confirmed by a movement disorder specialised neurologist with Hoehn and Yahr staging 1 to 3
- Willingness and ability to understand nature and content of the study
- Ability to participate and comply with study requirements
Who cannot join
- Healthy subjects: previous or ongoing diseases of the central nervous system
- Patients: previous or ongoing diseases of the central nervous system, other than Parkinson's disease
- History of or current psychiatric treatment
- History of or current brain surgery or epilepsy, unclusing deep brain stimulation
- Neuromuscular disorders
- Pre-existing pulmonary disease, such as chronic obstructive pulmonary disease, asthma or pulmonary fibrosis
Show all 11Show fewer
- TMS incompatibility (metal parts in head or neck, skin allergies)
- Implanted cardiac pacemaker or defibrillator, neurostimulator, cochlear implant or medical infusion device
- Large or ferromagnetic metal parts in the head (exept for a dental wire)
- Pregnancy
- Smoking
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Radboudumc
Nijmegen, Gelderland, 6500 HB
Jonne Doorduin, PhD, +31650155757, jonne.doorduin@radboudumc.nl
About this study
Official title: Neural Control of Breathing in Parkinson's Disease: an Exploratory Study
Breathing is a complex process, which can be controlled through voluntary command or neural control. Parkinson's disease (PD) is a progressive neurological disorder. Many individuals with PD experience respiratory problems, such as coughing difficulties or shortness of breath. Changes in neural control of breathing could be part of the reason of these respiratory problems. This study will measure whether neural control of breathing is impaired in individuals with PD compared to healthy individuals.
Read the detailed description
Rationale: Parkinson's disease (PD) is a progressive neurological disorder, characterised by loss of dopaminergic neurons. Respiratory dysfunction is common in patients with PD and can lead to pneumonia, which is a common cause of death in PD. However, the exact mechanism of respiratory dysfunction in PD is unknown. The complex process of neural control of breathing may be involved, but this is understudied. This is partly caused by methodological limitations to quantify neural control of breathing. In this study, we will use respiratory neurophysiological methods to determine whether neural control of breathing is impaired in Parkinson's disease. These techniques are hypercapnic ventilatory response, respiratory related evoked potentials and transcranial magnetic stimulation. This study will test the hypothesis that the neural control of breathing is impaired in individuals with PD compared to healthy subjects.
Objective: Primary Objective: To identify disease (Parkinson's disease) specific alterations in neural control of breathing by using respiratory neurophysiological techniques.
Study design: Exploratory cross-sectional study.
Study population: Healthy subjects (n=15) and patients with Parkinson's disease (n=15) >18 years old.
Main study parameters/endpoints:
- Hypercapnic ventilatory response curve (HCVR): HCVR will be determined using the CO2-rebreathing technique.
- Respiratory related evoked potential (RREP): RREP is a measure of cerebral cortical activity elicited by a short inspiratory occlusion.
- Transcranial magnetic stimulation (TMS) diaphragm: TMS is an established tool for investigating the cortical excitability related to breathing.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risk of this study for the participants is negligible. Subjects do not directly benefit from participating in this study. The scientific benefit of this study is to achieve a better understanding of the neural control of breathing in Parkinson's disease. The outcomes of this study may give rise to future new treatments in Parkinson's disease. The burden of the separate study procedures is relatively small: there are no invasive procedures and patients continue their medication as usual. However, the total time of the visit and the collective burden of the experiments may be perceived as strenuous. Therefore, subjects will be explicitly informed about this aspect of the study, and enough breaks will be scheduled in the program.
- Conditions
- Parkinson Disease
- Being tested
- Hypercapnic ventilatory response, Respiratory related evoked potential, Transcranial magnetic stimulation
- Keywords
- Parkinson's disease, Respiratory dysfunction, Neural control of breathing, Transcranial magnetic stimulation, Hypercapnic ventilatory response, Respiratory related evoked potential
- Medical subject headings
- Parkinson Disease, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypercapnic ventilatory responseDiagnostic test
Control of breathing is predominantly regulated by feedback of the central chemoreceptors. All chemoreceptors are sensitive to changes in partial pressure of carbon dioxide and via acid-base reactions to hydrogen concentration. The hypercapnic ventilatory response test shows the relationship between end-tidal PCO2 and the resulting minute ventilation.
Respiratory related evoked potentialDiagnostic test
The RREP is a measure of cerebral cortical activity elicited by short inspiratory occlusion or breathing against inspiratory resistive loads and quantifies the initial arrival and further processing of sensory afferent respiratory information in the cortex.
Transcranial magnetic stimulationDiagnostic test
Transcranial magnetic stimulation of the diaphragm is an established tool for investigating the cortical excitability related to breathing. TMS will be delivered over the vertex using a magnetic stimulator and a 110mm double cone coil.
| Study group | Role | What they receive |
|---|---|---|
| Parkison's disease | Participants with clinically confirmed Parkinson's disease, Hoehn and Yahr stage 1 to 3. Receives: Diagnostic Test: Hypercapnic ventilatory response; Diagnostic Test: Respiratory related evoked potential; Diagnostic Test: Transcranial magnetic stimulation | |
| Healthy controls | Participants without Parkinson's disease. Receives: Diagnostic Test: Hypercapnic ventilatory response; Diagnostic Test: Respiratory related evoked potential; Diagnostic Test: Transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypercapnic ventilatory response curve
Sensitivity slope of the ventilation increase per unit increase in PetCO2, as measured with a rebreathing technique.
Measured: baseline - during the test
Respiratory related evoked potential
A measure of cerebral cortical activity elicited by a short inspiratory occlusion, expressed in the presence, latency and amplitude of components Nf, P1, N1, P2 and P3.
Measured: baseline - during the test
Transcranial magnetic stimulation
Interstimulus interval curves, using a conditioning stimulus at 80% and a test stimulus at 125%.
Measured: baseline - during the test
Secondary outcomes (4)
FVC
Forced vital capacity.
Measured: baseline - during the test
FEV1
Forced expiratory volume in 1 second.
Measured: baseline - during the test
MIP
Maximal inspiratory pressure.
Measured: baseline - during the test
MEP
Maximal expiratory pressure.
Measured: baseline - during the test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start30 Oct 2023
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonne Doorduin, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074614
- Sponsor's protocol ID
- NL84745.091.23
- Acronym
- NEURON-PD
- Status last verified
- Dec 2024
- First submitted
- 3 Oct 2023
- Last updated
- 20 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Control of Breathing in Parkinson's Disease: an Exploratory Study
- ClinicalTrials.gov ID
- NCT06074614
- Acronym / sponsor ID
- NEURON-PD / NL84745.091.23
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's disease, Respiratory dysfunction, Neural control of breathing, Transcranial magnetic stimulation, Hypercapnic ventilatory response, Respiratory related evoked potential
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breathing is a complex process, which can be controlled through voluntary command or neural control. Parkinson's disease (PD) is a progressive neurological disorder. Many individuals with PD experience respiratory problems, such as coughing difficulties or shortness of breath. Changes in neural control of breathing could be part of the reason of these respiratory problems. This study will measure whether neural control of breathing is impaired in individuals with PD compared to healthy individuals.
Detailed description
Rationale: Parkinson's disease (PD) is a progressive neurological disorder, characterised by loss of dopaminergic neurons. Respiratory dysfunction is common in patients with PD and can lead to pneumonia, which is a common cause of death in PD. However, the exact mechanism of respiratory dysfunction in PD is unknown. The complex process of neural control of breathing may be involved, but this is understudied. This is partly caused by methodological limitations to quantify neural control of breathing. In this study, we will use respiratory neurophysiological methods to determine whether neural control of breathing is impaired in Parkinson's disease. These techniques are hypercapnic ventilatory response, respiratory related evoked potentials and transcranial magnetic stimulation. This study will test the hypothesis that the neural control of breathing is impaired in individuals with PD compared to healthy subjects.
Objective: Primary Objective: To identify disease (Parkinson's disease) specific alterations in neural control of breathing by using respiratory neurophysiological techniques.
Study design: Exploratory cross-sectional study.
Study population: Healthy subjects (n=15) and patients with Parkinson's disease (n=15) >18 years old.
Main study parameters/endpoints:
- Hypercapnic ventilatory response curve (HCVR): HCVR will be determined using the CO2-rebreathing technique.
- Respiratory related evoked potential (RREP): RREP is a measure of cerebral cortical activity elicited by a short inspiratory occlusion.
- Transcranial magnetic stimulation (TMS) diaphragm: TMS is an established tool for investigating the cortical excitability related to breathing.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risk of this study for the participants is negligible. Subjects do not directly benefit from participating in this study. The scientific benefit of this study is to achieve a better understanding of the neural control of breathing in Parkinson's disease. The outcomes of this study may give rise to future new treatments in Parkinson's disease. The burden of the separate study procedures is relatively small: there are no invasive procedures and patients continue their medication as usual. However, the total time of the visit and the collective burden of the experiments may be perceived as strenuous. Therefore, subjects will be explicitly informed about this aspect of the study, and enough breaks will be scheduled in the program.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkison's disease | – | Diagnostic Test: Hypercapnic ventilatory response, Diagnostic Test: Respiratory related evoked potential, Diagnostic Test: Transcranial magnetic stimulationParticipants with clinically confirmed Parkinson's disease, Hoehn and Yahr stage 1 to 3. |
| Healthy controls | – | Diagnostic Test: Hypercapnic ventilatory response, Diagnostic Test: Respiratory related evoked potential, Diagnostic Test: Transcranial magnetic stimulationParticipants without Parkinson's disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy participants: volunteers. Age- and sex-matched to the participants with Parkinson's disease. Participants with Parkinson's disease: recruited through the outpatient registry at the Radboud University Medical Center that have approved contact for research purposes.
Key inclusion criteria (4 listed)
- Healthy subjects: competent adult (>18 years) volunteers
- Patients: adult (<18 years) patients with Parkinson's disease, clinically confirmed by a movement disorder specialised neurologist with Hoehn and Yahr staging 1 to 3
- Willingness and ability to understand nature and content of the study
- Ability to participate and comply with study requirements
Key exclusion criteria (11 listed)
- Healthy subjects: previous or ongoing diseases of the central nervous system
- Patients: previous or ongoing diseases of the central nervous system, other than Parkinson's disease
- History of or current psychiatric treatment
- History of or current brain surgery or epilepsy, unclusing deep brain stimulation
- Neuromuscular disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypercapnic ventilatory responseControl of breathing is predominantly regulated by feedback of the central chemoreceptors. All chemoreceptors are sensitive to changes in partial pressure of carbon dioxide and via acid-base reactions to hydrogen concentration. The hypercapnic ventilatory response test shows the relationship between end-tidal PCO2 and the resulting minute ventilation. | Diagnostic test | Healthy controls, Parkison's disease |
| Respiratory related evoked potentialThe RREP is a measure of cerebral cortical activity elicited by short inspiratory occlusion or breathing against inspiratory resistive loads and quantifies the initial arrival and further processing of sensory afferent respiratory information in the cortex. | Diagnostic test | Healthy controls, Parkison's disease |
| Transcranial magnetic stimulationTranscranial magnetic stimulation of the diaphragm is an established tool for investigating the cortical excitability related to breathing. TMS will be delivered over the vertex using a magnetic stimulator and a 110mm double cone coil. | Diagnostic test | Healthy controls, Parkison's disease |
Primary outcome
Hypercapnic ventilatory response curve
Time frame: baseline - during the test
Sensitivity slope of the ventilation increase per unit increase in PetCO2, as measured with a rebreathing technique.
Respiratory related evoked potential
Time frame: baseline - during the test
A measure of cerebral cortical activity elicited by a short inspiratory occlusion, expressed in the presence, latency and amplitude of components Nf, P1, N1, P2 and P3.
Transcranial magnetic stimulation
Time frame: baseline - during the test
Interstimulus interval curves, using a conditioning stimulus at 80% and a test stimulus at 125%.
4 secondary outcomes
FVC
Time frame: baseline - during the test
FEV1
Time frame: baseline - during the test
MIP
Time frame: baseline - during the test
MEP
Time frame: baseline - during the test
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonne Doorduin, PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonne Doorduin, PhD (+31243611111, jonne.doorduin@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypercapnic ventilatory response curve (time frame: baseline - during the test). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.