Novel Management of Airway Protection in Parkinson's Disease: A Clinical Trial

NCT02927691 | Completed Phase 2 Results DMC

• 1 other identifier: 542528
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

Currently, there are no efficacious behavioral treatment approaches to address uncompensated aspiration, or aspiration without appropriate cough response, in Parkinson's disease (PD). This is of particular public health concern given that aspiration pneumonia is the leading cause of death in persons with PD. The overarching aim of the proposed study is to determine the efficacy of two distinct intensive rehabilitation paradigms, expiratory muscle strength training (EMST) and sensorimotor treatment for airway protection (smTAP), on airway protective clinical outcomes in persons with PD and dysphagia. The investigators anticipate the results will lead to reductions in the risks associated with airway protective deficits.

Conditions

Parkinson's Disease; Dysphagia; Dystussia

Keywords

Rehabilitation; Parkinson's disease; Swallowing; Cough; Dysphagia; Dystussia

Outcome Measures

Primary Outcomes (1)

• Change in Voluntary Cough Peak Flow

  Peak expiratory flow rate (PEFR) was measured before (baseline) and after 5 weeks of treatment with EMST and smTAP.

  Pre to Post treatment (Pre: Baseline and Post Treatment: 5 weeks)

Study Arms (2)

Immediate Treatment

EXPERIMENTAL

Participants will begin treatment immediately following baseline testing.

Device: EMST; Behavioral: smTAP

Delayed Treatment

OTHER

Following baseline testing, participants will receive no treatment for five weeks, then begin treatment immediately following a second baseline testing session.

Device: EMST; Behavioral: smTAP

Interventions

EMST DEVICE

Delayed Treatment; Immediate Treatment

smTAP BEHAVIORAL

Delayed Treatment; Immediate Treatment

Eligibility Criteria

• Age: 45 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)
• Difficulty swallowing
• Not actively receiving swallowing therapy.

You may not qualify if:

• Other neurological disorders (e.g., multiple sclerosis, stroke, 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

Sponsors & Collaborators

• Teachers College, Columbia University: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator
• University of Florida: collaborator

Study Sites (1)

Teachers College, Columbia University

New York, New York, 10027, United States

Location

Related Publications (1)

• Troche MS, Curtis JA, Sevitz JS, Dakin AE, Perry SE, Borders JC, Grande AA, Mou Y, Vanegas-Arroyave N, Hegland KW. Rehabilitating Cough Dysfunction in Parkinson's Disease: A Randomized Controlled Trial. Mov Disord. 2023 Feb;38(2):201-211. doi: 10.1002/mds.29268. Epub 2022 Nov 7.

  PMID: 36345090 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Deglutition Disorders; Cough

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; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Treatment adherence to the home program was measured via patient logs, which have potential to be unreliable. Another limitation is that capsaicin is not immediately available to clinicians, which can limit translation of our findings to clinical settings. Though this study included patients with mild to severe Parkinson's disease and dysphagia, it will be necessary to study whether these findings are replicated in a larger cohort of patients with severe Parkinson's disease and dysphagia.

Results Point of Contact

• Title: Michelle Troche
• Organization: Teachers College, Columbia University

mst2139@tc.columbia.edu

212-678-3953

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: October 7, 2016
• Study Start: September 1, 2016
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: December 22, 2023
• Results First Posted: December 22, 2023

Record last verified: 2023-12

Locations

US (1)