Neural Control of Breathing in Parkinson's Disease

NCT06074614 | Recruiting

• 1 other identifier: NL84745.091.23
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Parkinson Disease

Keywords

Parkinson's disease; Respiratory dysfunction; Neural control of breathing; Transcranial magnetic stimulation; Hypercapnic ventilatory response; Respiratory related evoked potential

Outcome Measures

Primary Outcomes (3)

• Hypercapnic ventilatory response curve

  Sensitivity slope of the ventilation increase per unit increase in PetCO2, as measured with a rebreathing technique.

  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.

  baseline - during the test

• Transcranial magnetic stimulation

  Interstimulus interval curves, using a conditioning stimulus at 80% and a test stimulus at 125%.

  baseline - during the test

Secondary Outcomes (4)

• FVC

  baseline - during the test

• FEV1

  baseline - during the test

• MIP

  baseline - during the test

• MEP

  baseline - during the test

Study Arms (2)

Parkison's disease

Participants with clinically confirmed Parkinson's disease, Hoehn and Yahr stage 1 to 3.

Diagnostic Test: Hypercapnic ventilatory response; Diagnostic Test: Respiratory related evoked potential; Diagnostic Test: Transcranial magnetic stimulation

Healthy controls

Participants without Parkinson's disease.

Diagnostic Test: Hypercapnic ventilatory response; Diagnostic Test: Respiratory related evoked potential; Diagnostic Test: Transcranial magnetic stimulation

Interventions

Hypercapnic ventilatory response DIAGNOSTIC_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.

Healthy controls; Parkison's disease

Respiratory related evoked potential DIAGNOSTIC_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.

Healthy controls; Parkison's disease

Transcranial magnetic stimulation DIAGNOSTIC_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.

Healthy controls; Parkison's disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6500 HB, Netherlands

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Dyspnea

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonne Doorduin, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonne Doorduin, PhD

CONTACT

+31243611111; jonne.doorduin@radboudumc.nl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 10, 2023
• Study Start: October 30, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: December 20, 2024

Record last verified: 2024-12

Locations

NL (1)