Tongue-strengthening exercises for people with ALS
The Impact of Dysphagia Exercise on Oropharyngeal Swallowing Function in Patients With ALS
This program will test whether daily tongue-strengthening exercises can help people with ALS maintain or improve speech and swallowing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Nova Southeastern University Academic / other |
| Locations | 1 site (Davie, Florida) |
| Trial ID | NCT07295990 on ClinicalTrials.gov |
What this trial studies
This single-site within-subject trial delivers a five-week lingual isometric resistance training program in which each participant serves as their own control. Participants complete two in-person visits (baseline and post-treatment) and five weekly telehealth sessions with a speech-language pathologist while using a home lingual manometer (Tongueometer) to record strength and support exercises. Outcome measures collected longitudinally include speaking rate (Bamboo Passage), the 3-ounce water swallow screen, TOMASS, lingual strength measures, and patient-reported scales (ETBQ, EAT-10, ALSFRS). Treatment-related changes will be compared to each participant’s baseline to determine safety, feasibility, and functional effects.
Who should consider this trial
Good fit: People with a diagnosis of possible, probable, or definite ALS who have measurable tongue weakness, can generate isometric lingual pressure, are naïve to lingual exercise programs, and can attend two visits in Davie, Florida are the intended candidates.
Not a fit: Patients who are anarthric, NPO, have a tracheostomy, cannot generate tongue pressure, or have other excluded neurologic/head and neck conditions are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the exercises could help maintain or improve tongue strength, which may make swallowing safer and speech clearer for people with ALS.
How similar studies have performed: Tongue-strengthening programs have produced improvements in tongue strength and swallowing in stroke and older adults, but direct evidence in ALS is limited and preliminary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of possible, probable, or definite ALS (El-Escorial Revisited) * Lingual exercises naïve * Impaired lingual strength generation compared to normative data * EAT-10 score \<3 Exclusion Criteria: * Stroke * Head injury * Head and neck cancer * Tracheostomy * Other concomitant neurogenic disorder * Recent oral surgery other than routine dental surgery * Unable to generate isometric lingual pressure on lingual manometer * Participation in another clinical trial intervention that may confound results * NPO (nothing by mouth) * Anarthric
Where this trial is running
Davie, Florida
- Nova Southeastern University — Davie, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Lauren Tabor Gray, Ph.D. — Neuroscience Institute, Cathy J. Husman ALS Center
- Study coordinator: Raquel Garcia, SLP.D.
- Email: rw602@nova.edu
- Phone: 17863994053
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.