K01 Impacts of Lingual Endurance Exercise

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

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.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke; Dysphagia; Dysphagia, Oropharyngeal
• Intervention / Treatment: Behavioral: Isotonic Endurance Exercise; Behavioral: Sham Exercise

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna Hopkins, MS; Phone Number: +1 513 558 4152; Email: hopkiak@ucmail.uc.edu
• Study Contact Backup: Name: Rebecca Reinert; Phone Number: +1 513 558 1719; Email: gibsonrk@ucmail.uc.edu

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Recruiting
      • University of Cincinnati
      • Principal Investigator: Brittany Krekeler, PhD
      • Contact: Anna Hopkins, MS; Phone Number: 513-558-4152; Email: hopkiak@ucmail.uc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1) 3-6 months since most recent diagnosis of ischemic, non-hemorrhagic stroke occurring in areas involving anterior or posterior circulation and affecting underlying cortical or subcortical structures (including brainstem)
• 2) able to tolerate some oral intake required for assessment of swallowing function via modified barium swallow study (MBSS) 4) able to follow 2-step commands.
• 3) MBSImP Oral Total (OT) score >10 on Modified Barium Swallow Study (MBSS)

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, Parkinsons, dementia).
• 4) Any history of dysphagia from prior stroke will be exclusionary.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lingual Endurance Exercise; The experimental exercise group will participate in 3 training sessions per day for 8 weeks. Endurance exercise will include completing isotonic endurance repetitions 3 times a day. Number of repetitions per session will be determined during baseline testing for each participant.	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 Comparator: Sham Exercise; The sham control group will be instructed to press the lingual sensor 30 times at a very low-pressure threshold (1-5 kPa), which will be monitored weekly via device output sent to the study team to avoid use of excessive force that would qualify as exercise (>5 kPa).	Behavioral: Sham Exercise; Pressing tongue against pressure sensor at a low threshold (1-5kPa) 30x/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Normalized Residue Ratio Scale (NRRS)	Measure of swallow efficiency by calculating the amount of residue remaining after a swallow	Change from Baseline (at the end of 8 weeks)
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)
Adherence	number of repetitions attempted/total number of repetitions prescribed	At the end of 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: September 19, 2023
• First Submitted That Met QC Criteria: October 2, 2023
• First Posted (Estimated): October 9, 2023

Study Record Updates

• Last Update Posted (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Stroke; Ischemic Stroke; Deglutition Disorders
• Other Study ID Numbers: 2023-0582 Lingual Endurance; 1K01HD111680-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan currently to share IPD with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No