Primary Objective: To identify disease (Parkinson*s disease) specific alterations in neural control of breathing by using respiratory neurophysiological techniques.
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- 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.
Secondary outcome
Not applicable.
Background summary
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 disfunction 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.
Study 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 burden and risks
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.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
- Healthy subjects: competent adult volunteers
- Patients: adult patients with Parkinson*s disease with Hoehn and Yahr staging
1 to 3, clinically confirmed by a movement disorder specialised neurologist
- Willingness and ability to understand nature and content of the study
- Ability to participate and comply with study requirements
Exclusion criteria
- 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, including 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 (except for a dental wire)
- Pregnancy
- Smoking
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84745.091.23 |