Your Mind Can Exercise Too: Swallowing Motor Imagery Practice

NCT06526910 | Not Yet Recruiting

• 1 other identifier: EXPD-HP-24-S-6
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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 hallmarks of dysphagia in patients with PD include tongue weakness, reduced swallowing frequency and efficiency, and airway invasion. Evidence for effective treatment techniques to address dysphagia in patients with PD is limited and urgently needed, substantiating the systematic study of standard-of-care treatments in this population as well as the development of novel techniques. Motor imagery practice (MIP) is a mentally rehearsed form of exercise that does not involve muscle activation and has been shown to improve motor outcomes in limb rehabilitation. MIP is novel to swallowing rehabilitation. Our group has conducted preliminary MIP studies in healthy older adults and demonstrated improved measures of tongue strength and swallowing pressure when MIP is used in combination with physical tongue exercise compared to physical tongue exercise alone. The next step is to evaluate the use of MIP in patients with dysphagia. The purpose of this research is to determine the feasibility and effect of MIP when added to a physical swallowing-related exercise protocol for patients with PD. Changes in tongue pressure generation, spontaneous swallowing frequency, functional physiological swallowing outcomes, and patient-reported outcomes will be examined. This research aims to fill gaps in evidence specific to dysphagia in patients with PD and to evaluate a novel rehabilitation method. The investigators anticipate that the results of this study will inform clinical practice, with evidence for supporting the improvement of swallowing function and quality of life in patients with PD, and lay the groundwork for the design of future randomized controlled clinical trials.

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (1)

• Penetration-Aspiration Scale score

  The most severe level of airway invasion will be determined using the Penetration and Aspiration Scale, an eight-point nominal scale (0-8, 8 representing the most severe form of airway invasion) that allows the clinical to define the depth of food/liquid entering the airway and the patient response to it (e.g., coughing).

  Measured at 3 timepoints across the study for each participant: baseline, immediately after Phase 1 intervention, immediately after Phase 3 intervention

Secondary Outcomes (7)

• Tongue pressures

  Multiple timepoints across the study as part of the single case series study design, e.g., baseline, up to twice a week during each Phase, post-intervention

• Spontaneous swallowing frequency

  Measured at 3 timepoints across the study for each participant: baseline, immediately after Phase 1 intervention, immediately after Phase 3 intervention

• Swallowing-related quality-of-life

  Measured at 3 timepoints across the study for each participant: baseline, immediately after Phase 1 intervention, immediately after Phase 3 intervention

• Radboud Oral Motor Inventory for Parkinson's disease (ROMP)

  Measured at 3 timepoints across the study for each participant: baseline, immediately after Phase 1 intervention, immediately after Phase 3 intervention

• Dysphagia severity level

  Measured at 3 timepoints across the study for each participant: baseline, immediately after Phase 1 intervention, immediately after Phase 3 intervention

Study Arms (4)

Phase 1 Standard of Care

ACTIVE COMPARATOR

A four-week period of standard of care dysphagia treatment consisting of physical swallowing-related exercises. According to guidelines for single case design, this standard of care treatment will serve as a baseline/control period for comparison to the subsequent experimental treatment period. Participants will complete either 6, 7, or 8 baseline measurement visits across these 4 weeks (multiple baseline design).

Behavioral: Swallowing exercises

Phase 2 Wash-out period #1

NO INTERVENTION

A three-week wash-out period. All participants will attend 6 measurement sessions across the 3-week period but will not complete any swallowing exercises.

Phase 3 "Experimental"

EXPERIMENTAL

A four-week exercise period. Five participants will be assigned to complete a second period of standard of care swallowing exercises while the other five will be assigned to the experimental treatment which includes standard of care plus motor imagery practice. According to single case design, participants will complete either 6, 7, or 8 measurement visits across these 4 weeks.

Behavioral: Swallowing exercises

Phase 4 Wash-out period #2

NO INTERVENTION

A final three-week wash-out period. All participants will attend 6 measurement sessions across the 3-week period but will not complete either the standard of care or the experimental swallowing exercises.

Interventions

Swallowing exercises BEHAVIORAL

Standard-of-care swallowing exercises include tongue exercise. The experimental part added in Phase 3 includes some participants completed standard-of-care exercises again and others completing standard-of-care exercises and motor imagery practice of those exercises.

Phase 1 Standard of Care; Phase 3 "Experimental"

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samford University: lead
• Case Western Reserve University: collaborator
• Emerson College: collaborator
• James Madison University: collaborator
• Texas Christian University: collaborator

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Sarah Szynkiewicz, PhD

  Samford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Szynkiewicz, PhD

CONTACT

205-726-4579; sszynkie@samford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a multiple baselines single case series study. Each participant will complete 4 sequential phases of the study. Phase 1 is standard of care dysphagia exercise (baseline), Phase 2 is wash-out (no exercise, Phase 3 is standard of care + motor imagery practice OR continued standard of care exercise only, and Phase 3 is a second wash-out period (no exercise).

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 30, 2024
• Study Start: August 8, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share