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Gentle neck zap may help ALS patients swallow again

NCT ID NCT07606235

Symptom relief Sponsor: Nova Southeastern University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tests a non-invasive device that stimulates a nerve in the neck to see if it can increase how often people with ALS swallow and their urge to swallow. Up to 5 participants will receive supervised treatment sessions and be monitored with swallowing tests. The goal is to check if the approach is safe and feasible for a larger future trial.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
transcutaneous electrical nerve stimulation of the superior laryngeal nerve (TENS-SLN)
What this could lead to
If it works, this could point toward a non-invasive way to help people with ALS swallow more easily and safely.
What could go wrong
This is a very early pilot study with only 5 participants, designed to test feasibility, not effectiveness. It may not show meaningful improvement or lead to a proven treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 5 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

amyotrophic lateral sclerosis Deglutition Disorders

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amyotrophic lateral sclerosis (ALS) Dysphagia Dystussia

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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