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Active Not Recruiting
NCT05700825
Rehabilitation of Airway Protection in Parkinson's Disease
Conditions: Parkinson Disease, Dysphagia
Sex: All
Ages: 50 Years – 90 Years
Phase: PHASE2
Enrollment: 120
Sponsor: Teachers College, Columbia University
Location: United States
Summary
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.
Eligibility Criteria
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 criteriaairway 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 therapybetween the ages of 50 and 90.Exclusion criteria:Other neurological disorders (e.g., multiple sclerosis, stroke, brain tumor, etc.)history of head and neck cancerhistory of breathing disorders or diseases (e.g., COPD)history of smoking in the last five yearsuncontrolled hypertensiondifficulty 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 bariumfurther than 1.5 hours (door to door) distance from either Teachers College, Columbia University or Purdue University.
Source: ClinicalTrials.gov (NCT05700825). StuddyBuddy aggregates publicly available trial information.