Rehabilitation of Airway Protection in Parkinson's Disease
Recruiting · NCT05700825 · Interventional (participants receive a specific treatment) · Lead sponsor: Teachers College, Columbia University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Airway protective disorders are a prevalent and progressive consequence of Parkinson's Disease (PD), and often result in aspiration pneumonia which is the leading cause of death in PD. Despite this, a large number of patients with PD do not access specialized services to address these critical deficits. The investigators will examine the comparative effectiveness of a novel treatment paradigm delivered in-person versus via telehealth in persons with PD, as well as the role of patient burden and treatment adherence on outcomes; thus, the proposed research is relevant to public health and in line with NIH's mission to identify novel, efficacious, and accessible rehabilitation strategies for short- and long-term improvement of dysfunctional airway protection in PD.
Who can take part
Inclusion criteria
- Diagnosed with PD (Hoehn and Yahr Stages II-IV)126,127 confirmed by a Movement Disorders fellowship trained neurologist having reviewed the video recorded Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assessment for each participant and using strict UK brain bank criteria
- airway protective deficits as defined as a minimum of penetration of thin liquids (penetration-aspiration score\>3) as determined by instrumental swallowing assessment and/or dystussia as determined by voluntary cough assessment (PEFR ≤4.1 L/s)
- not actively receiving exercise-based swallowing therapy
- between the ages of 50 and 90.
Exclusion criteria
- Other neurological disorders (e.g., multiple sclerosis, stroke, brain tumor, etc.)
- history of head and neck cancer
- history of breathing disorders or diseases (e.g., COPD)
- history of smoking in the last five years
- uncontrolled hypertension
- difficulty complying due to neuropsychological dysfunction (i.e., severe depression with \>28 on the Beck Depression Index (BDI-II), dementia with \<19 on the Montreal Cognitive Assessment (MoCA))
- allergy to capsaicin or barium
- further than 1.5 hours (door to door) distance from either Teachers College, Columbia University or Purdue University.
Where it is running
2 locations listed across 2 US states.
- Purdue University - West Lafayette, Indiana, United States
- Teachers College, Columbia University - New York, New York, United States