K01 Impacts of Lingual Endurance Exercise

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Dysphagia, Dysphagia, Oropharyngeal, Ischemic Stroke, Stroke

In brief

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.

Key facts

Study ID: NCT06072924
Run by: University of Cincinnati
People needed: 70
Starts: 2023-09-01
Expected to finish: 2028-08-31
Last updated by the study team: 2025-12-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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).

Where it is running

University of Cincinnati — Cincinnati, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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