Rehabilitation of Airway Protection in Parkinson's Disease

NCT05700825 | Recruiting Phase 2 DMC

• 2 other identifiers: NS1263191R01NS126319
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Parkinson Disease; Dysphagia

Outcome Measures

Primary Outcomes (4)

• Change in Peak Expiratory Flow Rate (Cough PEFR) - phase 1

  Pretraining to posttraining (after four weeks of intensive training)

• Change in Peak Expiratory Flow Rate (Cough PEFR) - phase 2

  post-training to post one-year maintenance

• Change in Penetration-Aspiration Scale (PAS) - phase 1

  PAS, max value: 8 (most impaired), min value 1 (least impaired).

  Pretraining to posttraining (after four weeks of intensive training)

• Change in Penetration-Aspiration Scale (PAS) - phase 2

  PAS, max value: 8 (most impaired), min value 1 (least impaired).

  post-training to post one-year maintenance

Secondary Outcomes (8)

• Change in Maximum Expiratory Pressure - phase 1

  Pretraining to posttraining (after four weeks of intensive training)

• Change in Maximum Expiratory Pressure - phase 2

  post-training to post one-year maintenance

• Change in Cough expired volume - phase 1

  Pretraining to posttraining (after four weeks of intensive training)

• Change in Cough expired volume - phase 2

  post-training to post one-year maintenance

• Treatment Adherence - phase 1

  posttraining (after four weeks of intensive training)

Study Arms (2)

In-person

ACTIVE COMPARATOR

Behavioral: Expiratory Muscle Strength Training + Cough Skill Training

Telehealth

EXPERIMENTAL

Behavioral: Expiratory Muscle Strength Training + Cough Skill Training

Interventions

Expiratory Muscle Strength Training + Cough Skill Training BEHAVIORAL

Expiratory Muscle Strength Training (EMST). EMST is a widely used and efficacious treatment approach that uses a calibrated device with a one-way, spring-loaded pressure relief valve to mechanically overload the expiratory and submental muscles. Cough Skill Training (CST) involves a digital peak flow meter device which measures PEFR (peak expiratory flow rate) in liters/second and allows patients to receive immediate biofeedback.

In-person; Telehealth

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teachers College, Columbia University: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Purdue University: collaborator

Study Sites (2)

Purdue University

West Lafayette, Indiana, 47907, United States

RECRUITING

Teachers College, Columbia University

New York, New York, 10027, United States

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Deglutition Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Michelle Troche, PhD

  Teachers College, Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Troche, PhD

CONTACT

212-678-3072; uadlab@tc.columbia.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Principle Investigator

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 26, 2023
• Study Start: August 11, 2022
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (2)