A Digital Therapeutic Platform for Swallowing and Drooling Problems in Parkinson's

Launched by NORTHWESTERN UNIVERSITY · Dec 6, 2020

Keywords

ClinConnect Summary

This clinical trial is exploring a new digital tool designed to help patients with Parkinson's disease who have difficulty swallowing, a condition known as dysphagia, and issues with excessive drooling. The goal is to test a special wearable sensor that can track these problems more effectively. The study is currently looking for participants aged 22 and older who speak English and have been diagnosed with Parkinson's disease. To be eligible, participants need to have mild to moderate drooling and must be taking their Parkinson's medication when they join the assessments, which helps ensure that their symptoms are at their peak.

If you decide to participate, you will be helping researchers understand how well this sensor works in monitoring swallowing and drooling issues. It's important to know that there are some criteria that would exclude someone from joining, such as a recent history of certain medical conditions or treatments related to swallowing disorders. Overall, this trial aims to improve the quality of life for people with Parkinson's by providing better tools for managing these common challenges.

Gender

ALL

Eligibility criteria

• • Inclusion criteria. Age ≥22. English speaking. Diagnosis of idiopathic Parkinson's disease of any Hoehn and Yahr stage (I-V), determined by a neurologist.
• • Mild to moderate sialorrhea defined as a score of ≥ 11\* on the Radboud Oral Motor Inventory for Parkinson's Disease (ROMP)-Saliva (C) subscale Subjects must be in the "on" phase of their medication during all study assessments. The "on" phase is defined as the period when the participant's medication is at peak effectiveness, minimizing motor fluctuations and enabling optimal motor function.
• • Study Exclusion Criteria. History of aspiration pneumonia within the past 12 months. Unable to swallow saliva without a maneuver. Actively receiving treatment for swallowing disorders or sialorrhea. Current alcohol/drug abuse. Diagnosed with neurological disorders other than PD. End stage dementia. History of head and neck cancer or surgery. Unable to demonstrate competency with the user-friendly sensor platform technology.
• • Known allergy to contrast material used during MBSS. Known allergy to sensor adhesive. Indwelling tracheostomy tube. Nasogastric (NG) feeding tube. Currently pregnant.