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Could a zapping device help MS patients swallow safely?

NCT ID NCT05063708

Symptom relief Sponsor: I.R.C.C.S. Fondazione Santa Lucia 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether adding a mild electrical stimulation device to standard swallowing therapy helps people with multiple sclerosis who have trouble swallowing. 136 participants were randomly assigned to receive either real electrical stimulation or a sham device alongside their therapy. The goal was to see if the electrical stimulation improves swallowing function and reduces the risk of pneumonia.

What this could mean

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

Active substance
neuromuscular electrical stimulation (NMES) device
What this could lead to
If it works, this could offer a better way to improve swallowing safety and reduce pneumonia risk in people with multiple sclerosis.
What could go wrong
This is a completed trial, but results are not yet widely confirmed. Previous studies on NMES for swallowing have shown mixed results, so the added benefit may be small or absent.

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

136 people

The number who actually took part.

Started

Jan 2022

Finished

Apr 2024

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 years and older

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: * Diagnosis: definite MS (Thompson et al 2018) * Stability: recruited subjects must be in a stable phase of the disease, without relapses which induce worsening \> 1 point in the EDSS and with an EDSS \<=8 * ASHA\<6 and DYMUS \>2 * Novelty: subjects should not have been trained with dysphagia program in the last 6 month * Mini-Mental State Examination: \> 24 Exclusion Criteria: * Dysphagia related to other diseases * Presence of tracheal cannula * Local or general contraindications to the use of equipment for electrical muscle stimulation of the neck * Malignancies or acute inflammation in the anterior region of the neck. * Lack of collaboration due to mental impairment

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Conditions

The condition(s) this trial relates to.

Deglutition Disorders multiple sclerosis

As listed by the trial registrant

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

Deglutition disorders Multiple sclerosis

Contacts and locations

Locations

  • Santa Lucia foundation

    Roma, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.