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

Starting soon · Not applicable

Conditions studied: Amyotrophic Lateral Sclerosis (ALS), Dysphagia, Dystussia

In brief

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 facts

Study ID

NCT07606235

Run by

Nova Southeastern University

People needed

5

Starts

2026-06-01

Expected to finish

2026-12-01

Last updated by the study team

2026-05-26

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of ALS (El-Escorial Criteria)
• ALS FRS Bulbar Subscore of ≤ 10 and ≥ 3.
• Functional Oral Intake scale score ≥ 2

You may not qualify if…

• A diagnosis of significant cognitive impairment or frontotemporal dementia per the treating neurologist or neuropsychologist,
• Current nasogastric tube placement
• Current head and neck carcinoma
• Pacemaker or implanted defibrillator or history of diagnosed arrhythmia, bradycardia, or repeated attacks of hypotension,
• Implanted vagal nerve stimulator
• Current pregnancy
• History of epilepsy
• Infected, broken or inflamed skin on the neck, or impaired sensation at the site of sEMG or TENS placement
• Living greater than 50 miles from the NSU clinic round trip
• Any clinical reason that this stimulation may not be a suitable treatment according to the principal investigator.

Full record on ClinicalTrials.gov

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