Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
30 participants
OBSERVATIONAL
2023-10-30
2025-05-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Parkison's disease
Participants with clinically confirmed Parkinson's disease, Hoehn and Yahr stage 1 to 3.
Hypercapnic ventilatory response
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 potential
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 stimulation
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.
Healthy controls
Participants without Parkinson's disease.
Hypercapnic ventilatory response
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 potential
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 stimulation
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.
Interventions
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Hypercapnic ventilatory response
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 potential
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 stimulation
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Jonne Doorduin, PhD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
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Radboudumc
Nijmegen, Gelderland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Jonne Doorduin, PhD
Role: primary
Other Identifiers
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NL84745.091.23
Identifier Type: -
Identifier Source: org_study_id