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.
Confirmed diagnosis of ALS (El-Escorial Criteria)
ALS FRS Bulbar Subscore of ≤ 10 and ≥ 3.
Functional Oral Intake scale score ≥ 2
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,
Single group
Transcutaneous Superior Laryngeal Nerve Stimulation to Upregulate Swallowing Frequency and Urge to Swallow
Other interventionTranscutaneous Superior Laryngeal Nerve Stimulation to Upregulate Swallowing Frequency and Urge to Swallow in ALS
Swallowing Frequency
The count of swallows per unit time with predefined epochs
Urge-to-swallow
patient reported urge to swallow during rest and stimulation periods on a modified Borg scale, 0 (very easy) to 10 (very difficult to elicit a swallow)
Body weight gain/loss
The total body weight (lbs)
Maximum Expiratory Pressure
Maximum expiratory pressure achieved during forceful exhalation
Lingual pressure assessment
Maximum lingual pressure and saliva swallowing pressures will be obtained using the IOPI oral performance in 3 instances.
Peak cough flow
Maximum expiratory flow achieved during the expulsive phase of the cough (PCF, L/min)
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Nova Southeastern University
Lead sponsor
Curators of the University of Missouri
Collaborator
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