Study Results
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View full resultsBasic Information
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COMPLETED
119 participants
OBSERVATIONAL
2017-12-12
2023-09-29
Brief Summary
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Detailed Description
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The long-term goal of this research is to advance the management of airway protection deficits in patients with neurodegenerative disease in order to decrease morbidity and mortality due to aspiration related lung infection. The objective here, which is a critical step in pursuit of that goal, is to further specify the sensory mechanisms associated with airway protection disorders in order to advance the clinical management of these patients. In order to accomplish the objective of this application the study team has identified 3 aims: First, determine relationship(s) between airway somatosensation, reflex cough and swallowing function in people with PD, and how these relationships may change with disease progression, over time. Second, determine whether cortical processing of sensory information is associated with deficits in reflex cough sensitivity or swallowing function in people with PD, and third, to determine how the central neural filtering of airway sensory stimuli may relate to the development of airway protective disorders.
The study team will accomplish these aims in 2 experimental studies. First, the study team will test the magnitude of respiratory resistive loads, in people with PD across a range of disease durations, and in a healthy control group. The study team will measure reflex cough, using a cough-inducing irritant (capsaicin), and swallowing function. The study team will perform these tests at 3 time-points, spaced 10-14 months apart, in order to determine the relationships between respiratory sensation, cough sensitivity and effectiveness, and swallowing function, and how they change with advancing disease duration.
Next the study team will perform electroencephalographic recordings time-locked to paired respiratory stimuli to determine cortical processing of airway sensory information. The study team will measure the amplitude and latency of the sensory evoked potential peaks, and compute ratios of peak amplitude between the first and second paired stimulus in order to determine the degree of sensory gating. The realization of the proposed aims and studies is significant because it is a necessary step in our program of research that is expected to lead to earlier, more accurate identification, as well as targeted interventions for airway protection deficits in PD.
Completion of this research is systematically important for our goal of maintaining adequate airway protective function in PD patients; the results are expected to directly impact reductions in health care costs, morbidity, and mortality related to airway protection deficits.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Healthy controls
Men and women between the ages of 45 and 85 years without Parkinson's disease, or any history of neurologic disorder/disease, head or neck cancer, or chronic respiratory illness.
Capsaicin
Participants will inhale aerosolized capsaicin with the goal of this inducing cough and an urge-to-cough.
Resistive respiratory loads
Participants will breath through a mouthpiece. Every 3-5 breaths in, a respiratory load will be applied. Participants will be asked to rate the magnitude of the load.
Event-related evoked potential using electroencephalography (EEG).
The study team will use EEG time-locked to a respiratory occlusion to measure the brain's response to respiratory sensation.
Fluoroscopic swallow evaluation
Participants will swallow various consistencies of barium under fluoroscopy (moving-picture x-ray) in order to assess swallowing safety and efficiency.
Parkinson's disease
Men and women between the ages of 45 and 85 years with Parkinson's disease, and without any history of neurologic disorder/disease, head or neck cancer, or chronic respiratory illness.
Capsaicin
Participants will inhale aerosolized capsaicin with the goal of this inducing cough and an urge-to-cough.
Resistive respiratory loads
Participants will breath through a mouthpiece. Every 3-5 breaths in, a respiratory load will be applied. Participants will be asked to rate the magnitude of the load.
Event-related evoked potential using electroencephalography (EEG).
The study team will use EEG time-locked to a respiratory occlusion to measure the brain's response to respiratory sensation.
Fluoroscopic swallow evaluation
Participants will swallow various consistencies of barium under fluoroscopy (moving-picture x-ray) in order to assess swallowing safety and efficiency.
Interventions
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Capsaicin
Participants will inhale aerosolized capsaicin with the goal of this inducing cough and an urge-to-cough.
Resistive respiratory loads
Participants will breath through a mouthpiece. Every 3-5 breaths in, a respiratory load will be applied. Participants will be asked to rate the magnitude of the load.
Event-related evoked potential using electroencephalography (EEG).
The study team will use EEG time-locked to a respiratory occlusion to measure the brain's response to respiratory sensation.
Fluoroscopic swallow evaluation
Participants will swallow various consistencies of barium under fluoroscopy (moving-picture x-ray) in order to assess swallowing safety and efficiency.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of PD, Hoehn and Yahr stages I - IV, by a fellowship trained neurologist arriving at the diagnosis of PD by applying strict UK brain bank criteria (PD participants only)
Exclusion Criteria
2. Difficulty complying due to neuropsychological dysfunction (i.e., severe depression)
3. Allergy to capsaicin or hot peppers
4. History of head or neck cancer
5. History of smoking in the past 5 years
6. Any neurological disorder including PD (Healthy control group only)
45 Years
85 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of Florida
OTHER
Responsible Party
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Principal Investigators
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Karen Hegland, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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University of Florida Center for Movement Disorders and Neurorestoration
Gainesville, Florida, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form: ICF2_longitudinal
Document Type: Informed Consent Form: longitudinal study
Other Identifiers
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IRB201700959-N
Identifier Type: -
Identifier Source: org_study_id
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