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

NCT07606235 | Not Yet Recruiting

• 1 other identifier: 2026-127-NSU
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Amyotrophic Lateral Sclerosis (ALS); Dysphagia; Dystussia

Outcome Measures

Primary Outcomes (2)

• Swallowing Frequency

  The count of swallows per unit time with predefined epochs

  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)

  Measured from enrollment to the end of the 7 day follow up period

Secondary Outcomes (7)

• Body weight gain/loss

  At Day 1 and at Day 7

• Maximum Expiratory Pressure

  From enrollment to the end of the 7-day follow up period

• Lingual pressure assessment

  At baseline (Day 1) pre-procedural, on Day 1 post-procedure, and on Day 7

• Peak cough flow

  One at enrollment and one at the end of the 7- day folow-up period

• Videofluoroscopic Swallowing Evaluation

  At baseline and at the end of the 7-day follow-up period

Study Arms (1)

Interventional Group

EXPERIMENTAL

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

Interventions

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

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

Interventional Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Nova Southeastern University: lead
• Curators of the University of Missouri: collaborator

Related Publications (7)

• Tabor LC, Rosado KM, Robison R, Hegland K, Humbert IA, Plowman EK. Respiratory training in an individual with amyotrophic lateral sclerosis. Ann Clin Transl Neurol. 2016 Sep 1;3(10):819-823. doi: 10.1002/acn3.342. eCollection 2016 Oct.

  PMID: 27752517 BACKGROUND

• Tabor Gray, L., Locatelli, E., Vasilopoulos T., Wymer, J., Plowman, EK. (2022). Impact of Nuedexta on Bulbar Function and Physiology. Muscle and Nerve, 66(S2), S1-S63. https://doi.org/https://doi.org/10.1002/mus.27729

  BACKGROUND

• Robison R, Tabor-Gray LC, Wymer JP, Plowman EK. Combined respiratory training in an individual with C9orf72 amyotrophic lateral sclerosis. Ann Clin Transl Neurol. 2018 Aug 21;5(9):1134-1138. doi: 10.1002/acn3.623. eCollection 2018 Sep.

  PMID: 30250869 BACKGROUND

• Plowman EK, Watts SA, Tabor L, Robison R, Gaziano J, Domer AS, Richter J, Vu T, Gooch C. Impact of expiratory strength training in amyotrophic lateral sclerosis. Muscle Nerve. 2016 Jun;54(1):48-53. doi: 10.1002/mus.24990. Epub 2016 Mar 3.

  PMID: 26599236 BACKGROUND

• Plowman EK, Tabor-Gray L, Rosado KM, Vasilopoulos T, Robison R, Chapin JL, Gaziano J, Vu T, Gooch C. Impact of expiratory strength training in amyotrophic lateral sclerosis: Results of a randomized, sham-controlled trial. Muscle Nerve. 2019 Jan;59(1):40-46. doi: 10.1002/mus.26292. Epub 2018 Nov 29.

  PMID: 29981250 BACKGROUND

• Plowman EK, Gray LT, Chapin J, Anderson A, Vasilopoulos T, Gooch C, Vu T, Wymer JP. Respiratory Strength Training in Amyotrophic Lateral Sclerosis: A Double-Blind, Randomized, Multicenter, Sham-Controlled Trial. Neurology. 2023 Apr 11;100(15):e1634-e1642. doi: 10.1212/WNL.0000000000206830. Epub 2023 Feb 20.

  PMID: 36805435 BACKGROUND

• Ballenger, B., Barry, E., Wang, J., Haxton, C., Deninger, I., Thompson, R., Osman, K. L., & Lever, T. E. (2022). Targeted Electrical Stimulation of the Superior Laryngeal Nerve - A Potential Treatment for Dysphagia in ALS. The FASEB Journal, 36(S1). https://doi.org/https://doi.org/10.1096/fasebj.2022.36.S1.R4239

  BACKGROUND

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Deglutition Disorders

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Lauren Tabor Gray, Ph.D CCC-SLP

  Nova Southeastern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Racquel Garcia, SLPD, CCC-SLP

CONTACT

(954) 262-1271; rw602@nova.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm, within-subject (pre-post) design. All participants receive the investigational intervention (TENS-SLN), and outcomes are compared within subjects across baseline and post-intervention assessments. Non-invasive electrical stimulation delivered via a commercially available, FDA-approved TENS unit using surface electrodes positioned over the s Participants receive transcutaneous electrical nerve stimulation of the superior laryngeal nerve (TENS-SLN) during two supervised treatment sessions conducted within a 7-day period. Up to two additional visits may be used prior to treatment to individualize stimulation parameters. Stimulation is delivered using surface electrodes placed over the superior laryngeal nerve in the anterior neck and is titrated to evoke swallowing at a comfortable sensory level. Each treatment session includes up to 30 minutes of active stimulation (up to 15 minutes per side), with continuous physiological monitoring to assess swallowing frequency and safety.

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 26, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL