Exploring the Efficacy of the Effortful Swallow Maneuver for Improving Swallowing in People With PD

EFFORT-PD: Exploring the Efficacy of the Effortful Swallow Maneuver for Improving Swallowing in People With Parkinson Disease

The goal of this clinical trial is to learn whether a 4-week effortful swallow exercise program helps adults with Parkinson disease who have swallowing problems. The effortful swallow is a swallowing exercise where a person swallows with extra effort.

Researchers will compare adults who start the exercise program right away with adults who start the program after a 4-week waiting period. All participants who remain eligible will have the opportunity to receive the exercise program.

Participants will have swallowing assessments, including video X-ray swallowing tests called videofluoroscopy. They will also complete questionnaires and take part in a remotely supervised swallowing exercise program with a speech-language pathologist. Participants who remain eligible and take part in the exercise program will use a tongue pressure device during practice. The main study period lasts about 10 weeks. Participants will also complete brief follow-up questionnaires at 6 months and 12 months.

Inclusion Criteria:

• Age 18 years or older
• Neurologist-confirmed diagnosis of Parkinson disease
• Self-report of one or more swallowing symptoms, such as difficulty managing secretions, coughing during meals, choking on food, or respiratory infection other than COVID-19 in the past 6 months
• Baseline videofluoroscopic swallowing assessment showing prolonged time to laryngeal vestibule closure and/or poor pharyngeal area at maximum constriction on regular-effort swallows with thin or mildly thick liquid stimuli, relative to healthy reference values

Exclusion Criteria:

• History of head and neck cancer
• History of radical neck dissection, anterior cervical spine surgery, or neck/oropharyngeal surgery, except tonsillectomy or adenoidectomy
• History of any neurological disease other than Parkinson disease
• Cognitive or receptive communication difficulties that preclude the ability to follow English-language study instructions
• History of brain surgery, including deep brain stimulation