NCT05063708Completed
Neuromuscular Electrostimulation in Multiple Sclerosis People With Dysphagia
To Evaluate the Activity and the Efficacy of Traditional Swallowing Therapy (TST) Plus Neuromuscular Electrostimulation (NMES) vs TST Plus Sham- NMES in Multiple Sclerosis People With Dysphagia
Source: ClinicalTrials.gov · Last updated 25 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 136 (actual)
- First submitted
- 10 Aug 2021
- Start date
- 21 Jan 2022
- Primary completion date
- 15 Apr 2023
- Lead sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Diseases
- Multiple sclerosis
- NCT number
- NCT05063708
What you commit to
- Study type: Interventional
- Participants enrolled: 136
- From 21 Jan 2022 to the primary completion date, 15 Apr 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Dysphagia related to other diseases
- Malignancies or acute inflammation in the anterior region of the neck.
- Lack of collaboration due to mental impairment
Other
- Presence of tracheal cannula
- Local or general contraindications to the use of equipment for electrical muscle stimulation of the neck
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Santa Lucia foundation Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.