K01 Impacts of Lingual Endurance Exercise

University of Cincinnati

Status: Enrolling

Conditions: Ischemic Stroke; Dysphagia; Stroke; Dysphagia, Oropharyngeal

Treatments: Behavioral: Isotonic Endurance Exercise; Behavioral: Sham Exercise

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06072924

2023-0582 Lingual Endurance

1K01HD111680-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The goal of this clinical trial is to learn whether a tongue endurance exercise program can improve swallowing function in adults with dysphagia after a stroke. It also aims to explore how this exercise may affect brain structure and connectivity involved in swallowing. The main questions it aims to answer are:

Primary Aim: Does lingual endurance exercise improve swallowing function compared to a sham therapy? Secondary Aim: Does lingual endurance exercise lead to changes in brain structure or neuroplasticity, as measured by MRI?

Researchers will compare a group receiving tongue endurance exercises to a sham therapy group to see whether the treatment improves tongue function, swallowing.

Participants will:

• Complete a baseline swallowing assessment and MRI
• Be randomly assigned to either the lingual exercise or sham therapy group
• Complete 8 weeks of home-based tongue exercise therapy
• Return for follow-up swallowing assessments
• A subgroup of participants will complete a pre-treatment and post-treatment MRI.

Full description

This randomized, controlled clinical trial investigates the efficacy of a 8-week lingual endurance exercise program in adults with dysphagia following stroke. The study uses a two-arm, parallel-group design with participants randomized to either a lingual endurance exercise group or a sham therapy control group. Both interventions are delivered using a lingual manometer, which participants use at home under monitored conditions.

The primary aim is to evaluate changes in oral-phase swallowing physiology using the Modified Barium Swallow Impairment Profile (MBSImP) Oral Total Score, as assessed through video-fluoroscopic swallowing study (VFSS).

An exploratory aim will assess potential neuroplasticity associated with lingual endurance exercise using multimodal neuroimaging. Participants who meet MRI eligibility criteria undergo pre- and post-intervention imaging, including diffusion tensor imaging (DTI) to assess white matter integrity, high-resolution structural imaging for cortical thickness estimation, and functional MRI (task-based and resting state). Data will be used to evaluate intervention-related changes in regions associated with swallowing motor control and sensory integration.

This study also supports the investigator's training in clinical trial methodology, swallowing outcomes analysis, and neuroimaging techniques, and will inform a future, fully powered efficacy trial.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Lingual Endurance Exercise

Experimental group

Description:

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, and re-evaluated every 2 weeks, for each participant.

Treatment:

Behavioral: Isotonic Endurance Exercise

Sham Exercise

Sham Comparator group

Description:

The sham control group will be instructed to press the lingual sensor 30 times at a very low-pressure threshold (approximately 1-15 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.

Treatment:

Behavioral: Sham Exercise