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

May 18, 2026 updated by: Nova Southeastern University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Racquel Garcia, SLPD, CCC-SLP
  • Phone Number: (954) 262-1271
  • Email: rw602@nova.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional Group
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Swallowing Frequency
Time Frame: From enrollment to the end of the 7-day follow-up period
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
Time Frame: Measured from enrollment to the end of the 7 day follow up period
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body weight gain/loss
Time Frame: At Day 1 and at Day 7
The total body weight (lbs)
At Day 1 and at Day 7
Maximum Expiratory Pressure
Time Frame: From enrollment to the end of the 7-day follow up period
Maximum expiratory pressure achieved during forceful exhalation
From enrollment to the end of the 7-day follow up period
Lingual pressure assessment
Time Frame: At baseline (Day 1) pre-procedural, on Day 1 post-procedure, and on Day 7
Maximum lingual pressure and saliva swallowing pressures will be obtained using the IOPI oral performance in 3 instances.
At baseline (Day 1) pre-procedural, on Day 1 post-procedure, and on Day 7
Peak cough flow
Time Frame: One at enrollment and one at the end of the 7- day folow-up period
Maximum expiratory flow achieved during the expulsive phase of the cough (PCF, L/min)
One at enrollment and one at the end of the 7- day folow-up period
Videofluoroscopic Swallowing Evaluation
Time Frame: At baseline and at the end of the 7-day follow-up period
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)
At baseline and at the end of the 7-day follow-up period
Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
Time Frame: At baseline and again at the end of the 7 day follow up period
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
At baseline and again at the end of the 7 day follow up period
Body Weight (BMI)
Time Frame: Day 1 - Day 7
Total BMI measured at Baseline (day 1) and at the end of th study (Day 7)
Day 1 - Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Southeastern University

Collaborators

Curators of the University of Missouri

Investigators

  • Principal Investigator: Lauren Tabor Gray, Ph.D CCC-SLP, Nova Southeastern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 21, 2026

First Submitted That Met QC Criteria

May 18, 2026

First Posted (Actual)

May 26, 2026

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-127-NSU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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