K01 Impacts of Lingual Endurance Exercise

Ischemic Stroke Clinical Trial

Official title:

Impact of Lingual Endurance Exercise on Rehabilitation of Swallowing Impairments After Ischemic Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06072924
• Other study ID #: 2023-0582 Lingual Endurance
• Secondary ID: 1K01HD111680-01
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: August 31, 2028

Study information

• Verified date: April 2024
• Source: University of Cincinnati
• Contact: Anna Hopkins, MS
• Phone: +1 513 558 4152
• Email: hopkiak[@]ucmail.uc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Swallowing impairments (dysphagia) frequently occur after stroke and have devastating consequences on overall health and quality of life, and long-term deficits in swallow function also increase risk of morbidity (e.g. depression) and mortality (i.e. aspiration pneumonia). As such, rehabilitation of swallow function to improve safety and efficiency of swallowing is essential in this population. This study aims to: 1) Provide preliminary data to evaluate the effect of a novel lingual endurance exercise on swallow function in individuals with post-stroke dysphagia; and 2) Collect preliminary data regarding changes in white matter tract diffusion and cortical thickness and from MRI data to better understand effects of lingual exercise training on neuroplasticity.

Description:

This pilot trial will evaluate the effect of lingual endurance exercise (vs sham exercise) on recovery of swallow function after stroke. The Primary Aim of this study is to evaluate effects of lingual endurance exercise vs sham on swallow function in individuals with post-stroke dysphagia. The investigators hypothesize that lingual endurance training will result in greater improvement in measures of oral swallow physiology as compared to sham. Regardless of outcome, this dataset will provide innovative and highly novel information regarding the relationship between lingual function, swallowing impairments, and cortical representation of dysphagia in a post stroke population. These pilot data will be essential in providing sufficient power for designing an R01 Phase II intervention trial to investigate how to maximize gains with timing and intensity of therapy delivery to better recover swallow function after stroke.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 31, 2028
• Est. primary completion date: August 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 1) 3-6 months since most recent diagnosis of ischemic, confirmed from clinical imaging) with or without small hemorrhagic transformation (HI-1)

• 2) Have some indication of on-going swallowing issues

• 3) English Speaking

Exclusion Criteria:

• 1) =18 years of age

• 2) history of dysphagia prior to or after the stroke caused by any of the following conditions: gastrointestinal disease, traumatic brain injury, head and neck cancer, surgery involving the pharynx or larynx

• 3) history of other neurological disease (i.e. multiple sclerosis, ALS, Parkinson's, dementia).

• 4) Medium to large hemorrhagic transformation/involvement documented on clinical stroke imaging 5) 5) History of temporomandibular joint and muscle disorders (also known as TMJ).

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Dysphagia, Oropharyngeal
• Ischemic Stroke

Intervention

Behavioral:
• Isotonic Endurance Exercise
Pressing tongue against a pressure sensor at the set number of repetitions per session (individualized per participant) 3 times per day
• Sham Exercise
Pressing tongue against pressure sensor at a low threshold (1-15kPa) 30x/day

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
University of Cincinnati	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in fractional anisotropy (FA)	Diffusion Tensor Imaging (DTI) has been the most common analysis framework that is used to analyze the signal from diffusion MRI (dMRI) to gather information about the properties of the underlying white matter.	Change from Baseline (at the end of 8 weeks)
Other	Change in cortical thickness	Diffusion Tensor Imaging (DTI) has been the most common analysis framework that is used to analyze the signal from diffusion MRI (dMRI) to gather information about the properties of the underlying white matter.	Change from Baseline (at the end of 8 weeks)
Primary	Modified Barium Swallow Study Impairment Profile Oral Total (MBSImP OT Score)	MBSImP is a validated, standardized tool for assessing oral, pharyngeal, and esophageal swallowing function. We will be using change in OT score (sum of components 1-6) as our primary outcome measure.	Change from Baseline (at the end of 8 weeks)
Secondary	Pharyngeal Swallow Efficiency	Measurements via the ASPEKT method (Analysis of Swallowing Physiology: Events, Kinematics, and Timing) will be analyzed to compared pre and post treatment swallow efficiency. The amount will be presented as a percent of anatomical C2-C4 Scalar. Higher percentile, in general indicated greater impairment, however these will be compared to published normative data for reference.	Change from Baseline (at the end of 8 weeks)
Secondary	Penetration Aspiration Scale (PAS) Scores	8-point rating scale that is used to capture both degree and sensation of penetration and aspiration.	Change from Baseline (at the end of 8 weeks)
Secondary	Adherence	number of repetitions attempted/total number of repetitions prescribed	At the end of 8 weeks
Secondary	Pharyngeal Swallow Safety	Closure above the airway must be achieved for swallowing safety and in a timely manner. The ASPEKT method (Analysis of Swallow Physiology: Events, Kinematics and Timing) will be used to analyze changes of laryngeal vestibule closure pre and post treatment.	Change from Baseline (at the end of 8 weeks)