An interventional study of Transcutaneous Superior Laryngeal Nerve Stimulation to Upregulate Swallowing Frequency and Urge to Swallow in Amyotrophic Lateral Sclerosis (ALS), Dysphagia and Dystussia, sponsored by Nova Southeastern University. Not yet recruiting. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by Nova Southeastern University · Not applicable, Interventional, and Treatment
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.
This prospective, single-arm interventional pilot study will evaluate the acute effects of transcutaneous electrical nerve stimulation of the superior laryngeal nerve (TENS-SLN) on swallowing function in individuals with amyotrophic lateral sclerosis (ALS). Up to five participants with confirmed ALS and bulbar involvement will be enrolled. The primary outcomes are swallowing frequency and perceived urge to swallow.
Participants will complete a baseline assessment followed by two supervised TENS-SLN treatment sessions conducted within a one-week period. Up to two additional visits may be performed prior to treatment to optimize individualized stimulation parameters. Treatment sessions may take place in the clinic or the participant's home under clinician supervision. A final in-clinic evaluation will be completed at the end of the study period. Swallowing function will be assessed using physiological monitoring, fiberoptic endoscopy, and videofluoroscopic swallow study (VFSS) at baseline and post-intervention.
TENS-SLN is a non-invasive neuromodulation approach that delivers low-intensity electrical stimulation via surface electrodes placed over the anatomically accessible superior laryngeal nerve in the anterior neck. The intervention is designed to enhance sensory input to swallowing-related neural circuits and facilitate swallow initiation without directly eliciting muscle contraction.
This pilot study is not powered to determine efficacy but is intended to assess feasibility, safety, and preliminary effect sizes to inform the design of future randomized controlled trials. All study procedures are performed for research purposes and are not part of standard clinical care.
Exclusion Criteria:
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
Swallowing Frequency
The count of swallows per unit time with predefined epochs
Time frame: From enrollment to the end of the 7-day follow-up period
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)
Time frame: Measured from enrollment to the end of the 7 day follow up period
Body weight gain/loss
The total body weight (lbs)
Time frame: At Day 1 and at Day 7
Maximum Expiratory Pressure
Maximum expiratory pressure achieved during forceful exhalation
Time frame: From enrollment to the end of the 7-day follow up period
Lingual pressure assessment
Maximum lingual pressure and saliva swallowing pressures will be obtained using the IOPI oral performance in 3 instances.
Time frame: At baseline (Day 1) pre-procedural, on Day 1 post-procedure, and on Day 7
Peak cough flow
Maximum expiratory flow achieved during the expulsive phase of the cough (PCF, L/min)
Time frame: One at enrollment and one at the end of the 7- day folow-up period
Videofluoroscopic Swallowing Evaluation
Yale residue Scale to assess post-swallow residue in the pharynx following swallow trials. (5 point ordinal scale; graded 1 being none -5 being severe) Dynamic Imaging Grade of Swallowing Toxicity for FEES safety, efficiency, and total scores. (each subscore is graded on scale from 0-4; 0 being no impairment, being profound/life-threatening impairment)
Time frame: At baseline and at the end of the 7-day follow-up period
Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
New Zealand Secretion Scale to assess oropharyngeal secretions and clearance response on a 7-point ordinal scale. (Maximum 7- Minimum 0) Laryngeal Kinematics: presence of vocal fold adduction and abduction
Time frame: At baseline and again at the end of the 7 day follow up period
Body Weight (BMI)
Total BMI measured at Baseline (day 1) and at the end of th study (Day 7)
Time frame: Day 1 - Day 7
No study locations are listed for this record.
Plan to share: Yes — Data will be shared with the NSU study team and study collaborators. This includes Dr. Teresa Lever and Mario Awadala (University of Missouri). A clinical trial agreement is established to share this data, and verbiage is included in the informed consent document to inform participants of this agreement.
Supporting information: Study protocol
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Amyotrophic Lateral Sclerosis→
Nova Southeastern University