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NOT YET RECRUITING
NCT07606235
NA

Transcutaneous Superior Laryngeal Nerve Stimulation to Upregulate Swallowing Frequency and Urge to Swallow in Patients Living With ALS

Sponsor: Nova Southeastern University

View on ClinicalTrials.gov

Summary

Prospective, single-arm pilot study evaluating transcutaneous electrical nerve stimulation of the superior laryngeal nerve (TENS-SLN) in individuals with ALS. Up to 5 participants with confirmed ALS and bulbar involvement will be enrolled. Primary outcomes: swallowing frequency and perceived urge to swallow. Participants complete a baseline visit, followed by two supervised treatment sessions within one week, and a final post-treatment evaluation. Optional visits (up to 2) may be used to individualize stimulation parameters prior to treatment. Swallowing function will be assessed using physiological monitoring, fiberoptic endoscopy, and videofluoroscopic swallow study (VFSS). TENS-SLN is a non-invasive neuromodulation approach targeting sensory pathways to facilitate swallowing without inducing muscle contraction. This pilot study is designed to assess feasibility, safety, and preliminary effect sizes to inform future randomized trials, and is not powered to determine efficacy.

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

5

Start Date

2026-06

Completion Date

2026-12

Last Updated

2026-05-26

Healthy Volunteers

No

Interventions

OTHER

Transcutaneous Superior Laryngeal Nerve Stimulation to Upregulate Swallowing Frequency and Urge to Swallow

Transcutaneous Superior Laryngeal Nerve Stimulation to Upregulate Swallowing Frequency and Urge to Swallow in ALS