Status:
NOT_YET_RECRUITING
Your Mind Can Exercise Too: Swallowing Motor Imagery Practice
Lead Sponsor:
Samford University
Collaborating Sponsors:
Case Western Reserve University
Emerson College
Conditions:
Dysphagia
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
Swallowing difficulty (dysphagia) is a clinical symptom of Parkinson's disease (PD) that significantly impacts nutrition, oral secretion management, health status, and quality of life\]. Specific hall...
Detailed Description
The proposed study is a five-site research collaboration between Samford University (Birmingham, AL, Dr. Sarah Szynkiewicz), Case Western Reserve University (Cleveland, OH, Dr. Rachel Mulheren), Emers...
Eligibility Criteria
Inclusion
- Inclusion criteria. Individuals will be able to participate if they:
- Are \>/= 65 years of age as this is an independent predictor for dysphagia in PD
- Are diagnosed with moderate-stage Parkinson's disease (Hoehn \& Yahr disease stage 2-3)
- Disease duration \>3 years as this in an independent predictor for dysphagia in PD
- Are currently managed using an antiparkinsonian medication, including at least one dopaminergic drug (i.e., carbidopa/levodopa or a dopamine agonist)
- Have reduced tongue strength, defined as \< 45 kilopascals when completing a maximal isometric tongue push using the standard IOPI procedures
- Present with some dysphagia symptoms, defined as a score \> 3 on the Eating Assessment Tool (EAT-10)
- Have some mental imagery ability, defined as a score \> 2.5 greater on the KVIQ-10 short version
- Present with signs of dysphagia that are clinically detectable, as defined by a score \< 178 on the Mann Assessment of Swallowing Ability (MASA)
- Are cognitively able to participate, as defined by a score \> 19 on the telephone Montreal Cognitive Assessment (T-MoCA)
- Have a normal oral structure as assessed with a standardized oral mechanism exam
- Are fluent in English as all instruction will be provided in English
- Exclusion criteria. Individuals will not be eligible to participate if they report:
- Changes to their dopaminergic medication management anytime during enrollment
- They are currently recommended by a Speech-Language Pathologist to have NPO (nothing by mouth) status for safety reasons
- A history of oral surgery (routine dental surgery acceptable)
- Additional neurogenic disorders other than Parkinson's disease
- A history of swallowing difficulty prior to Parkinson's disease diagnosis
- A history of seizures
- A history of cancer that would impact oral-motor function
- A history of allergy to barium
- That they have initiated deep brain stimulation less than 3 months from the start of the study, or that they are anticipated to have a change in deep brain stimulation status during participation in the study
- Participation in other swallowing, speech, or voice treatments outside of the research treatment at the time of consent and anytime during enrollment
- Demonstration of normal swallowing function on first study-related modified barium swallow test, defined as a level 6 or higher on the Dysphagia Outcome and Severity Scale (DOSS). Therefore, participants must get a DOSS of 5 or lower, indicating at least mild oropharyngeal dysphagia, at baseline testing before beginning the treatment protocol. This reduces the risk of a null finding by eliminating the enrollment of participants with functional swallows or subclinical swallowing issues.
- A current pain disorder involving the jaw muscles or joint of the mandible (i.e., TMJ disorder or myofascial pain disorder)
- Not being available to complete a 16-week in-person study protocol
- Known or suspected perforation of the gastrointestinal (GI) tract
- Known obstruction of the GI tract
- High risk of GI perforation such as those with a recent GI perforation, acute GI hemorrhage or ischemia, toxic megacolon, severe ileus, post GI surgery or biopsy, acute GI injury or burn, or recent radiotherapy to the pelvis
- High risk for aspiration such as those with known or suspected tracheo-esophageal fistula or obtundation
- Known hypersensitivity to barium sulfate or any of the excipients of Varibar pudding
- No potential participant will be excluded on the basis of race, color, creed, sex, sexual orientation, or national origin.
Exclusion
Key Trial Info
Start Date :
August 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06526910
Start Date
August 8 2024
End Date
December 1 2024
Last Update
July 30 2024
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