K01 Impacts of Lingual Endurance Exercise (NCT06072924)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (5 items).
Location: University of Cincinnati — Cincinnati, Ohio
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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).
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- University of Cincinnati — Cincinnati, Ohio
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.