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Neuromuscular Electrostimulation in Multiple Sclerosis People With Dysphagia

NCT05063708 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2025-09-25

No results posted yet for this study

Summary

Dysphagia is a disabling, life-threatening symptom that can cause death in Multiple Sclerosis people (pwMS) through aspiration pneumonia. Speech therapists use behavioural therapies (compensatory and rehabilitative) to alleviate such swallowing problems, with limited benefit. Compensatory strategies such as postural changes and changes in food consistency, have been found to be partially effective, especially in patients with mild dysphagia and may be ineffective in patients with more severe dysphagia. The rehabilitative strategies include "no swallow exercises" which aim to strengthen isolated muscles used in swallowing (such as tongue strengthening) and "swallowing exercises" that aim at strengthening all the muscles used in swallowing while executing a hard, effortful, or prolonged swallow. To date, no randomized clinical trials have shown that rehabilitative strategies are effective. Neuromuscular electrical stimulation (NMES), often referred to as electrical stimulation, was introduced as a novel therapy for dysphagia in the late 2001. The principles of NMES in the limb rehabilitation literature are well established. However published protocols applying NMES to swallowing function have shown mixed results in people with stroke and only one study was published on MS people. This will be a double blinded, randomized clinical trial (patients and research staff blinded) with two arms: standard speech therapy plus Active NMES vs speech therapy with Sham NMES. The aim of this study is to determine whether NMES added benefit to a therapy program comprised of standard swallowing exercises in dysphagic pwMS.

Conditions

Interventions

DEVICE

Experimental: traditional dysphagia therapy plus Neuromuscular electrostimulation

In the present study, VitalStim equipment will be used (VitalStim Therapy; Chattanooga Group, Chattanooga, TN, USA). Therapists received additional training and information on NMES by an experienced laryngologist certified to use surface electrical stimulation.

DEVICE

Sham Comparator: Traditional dysphagia therapy plus sham Neuromuscular electrostimulation

Therapists received additional training and information on NMES by an experienced laryngologist certified to use surface electrical stimulation. The training was given according to the manual of the manufacturer, the VitalStim certification course (http://www.vitalstim.com).

Sponsors & Collaborators

  • I.R.C.C.S. Fondazione Santa Lucia

    lead OTHER

Principal Investigators

  • Maria Grazia Grasso, MD · Fondazione Santa Lucia Rome Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-21
Primary Completion
2023-04-15
Completion
2024-04-15

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05063708 on ClinicalTrials.gov