Neuromuscular Electrostimulation in Multiple Sclerosis People With Dysphagia

NCT05063708 | Completed DMC

• 2 other identifiers: CE/PROG.809No 2019/R -Multi/ 005
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief 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

Deglutition Disorders; Multiple Sclerosis

Keywords

Neuromuscular electrostimulation Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• change from American Speech-Language Hearing Association (ASHA) score baseline at 12 weeks

  The mean difference at ASHA score between group treated with traditional dysphagia therapy plus sham Neuromuscular electrostimulation vs group traditional dysphagia therapy plus neuromuscular electrostimulation will represent the primary outcome.ASHA suggests that patients should be divided in groups from level 1 (individuals cannot swallow anything safely by mouth) to level 7 (individual's ability to eat independently is not limited by swallowing function

  after 16 sessions of treatment and after 12 weeks from the end of treatment

Secondary Outcomes (6)

• Change from Dysphagia in Multiple Sclerosis (DYMUS) scale at 12 weeks

  after 16 sessions of treatment and after 12 weeks from the end of treatment

• Change from Fiber-optic endoscopic evaluation of swallowing /Dysphagia at Outcome Severity Scale (FESS/DOSS score) at 12 weeks

  after 16 sessions of treatment and after 12 weeks from the end of treatment

• Change from Mini Nutritional Assessment at 12 weeks

  after 16 sessions of treatment and after 12 weeks from the end of treatment

• Change from the Swallowing Quality of life questionnaire at 12 weeks

  after 16 sessions of treatment and after 12 weeks from the end of treatment

• Change from Penetration and Aspiration Score at 12 weeks

  after 16 sessions of treatment and after 12 weeks from the end of treatment

Study Arms (2)

Traditional dysphagia therapy plus sham Neuromuscular electrostimulation

SHAM COMPARATOR

Traditional dysphagia therapy (TDT) involved orofacial, lingual, and laryngeal motor exercises and compensatory swallowing strategies included various modifications of head, neck, and body postures and adjustment of food/liquid temperature, viscosity, and volume. The choice of specific strategies was based on the FEES findings and the clinical swallowing examination. The rehabilitative treatment will be administered in the 8 centers taking part to the study. The electrodes in this "sham" group will be placed in the same positions as the active treatment, with a current between 3 and 5 mA (average of 3.5 mA) current unable to perform muscle contraction. Every MS patient will be received 16 sessions of TDT according to their degree of dysphagia, contemporary associated with Sham neuromuscular electrostimulation two 30-min treatment a day, separated by a rest period of at least 45 minutes for four consecutive days per week, within a period of 4 weeks

Device: Sham Comparator: Traditional dysphagia therapy plus sham Neuromuscular electrostimulation

traditional dysphagia therapy plus Neuromuscular electrostimulation

EXPERIMENTAL

Every MS patient will be treated with traditional dysphagia therapy, associated with an active neuromuscular electrostimulation. The amplitude will be increased until the subject will feel a 'grabbing sensation' which corresponded to muscular contraction. This will be the amplitude used for the therapy. This process will be repeated for the second channel of the stimulator. The typical electrical stimulus is at 80 Hz and at 300 microsec, and it will be adapted to avoid annoying stimulus to the patients. During therapy, both channels will be active. Every MS patient will be received 16 sessions of traditional dysphagia therapy according to their degree of dysphagia, contemporary associated with neuromuscular electrostimulation , according to our previous experiences, two 30-min treatment a day, separated by a rest period of at least 45 minutes for four consecutive days per week, within a period of 4 weeks.

Device: Experimental: traditional dysphagia therapy plus Neuromuscular electrostimulation

Interventions

Experimental: traditional dysphagia therapy plus Neuromuscular electrostimulation DEVICE

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.

Also known as: traditional dysphagia therapy

traditional dysphagia therapy plus Neuromuscular electrostimulation

Sham Comparator: Traditional dysphagia therapy plus sham Neuromuscular electrostimulation DEVICE

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).

Also known as: traditional dysphagia therapy

Traditional dysphagia therapy plus sham Neuromuscular electrostimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• I.R.C.C.S. Fondazione Santa Lucia: lead

Study Sites (1)

Santa Lucia foundation

Roma, Italy

Location

Related Publications (5)

• Logemann JA. The effects of VitalStim on clinical and research thinking in dysphagia. Dysphagia. 2007 Jan;22(1):11-2. doi: 10.1007/s00455-006-9039-2. Epub 2007 Jan 10. No abstract available.

  PMID: 17216392 BACKGROUND

• Simonelli M, Ruoppolo G, Iosa M, Morone G, Fusco A, Grasso MG, Gallo A, Paolucci S. A stimulus for eating. The use of neuromuscular transcutaneous electrical stimulation in patients affected by severe dysphagia after subacute stroke: A pilot randomized controlled trial. NeuroRehabilitation. 2019;44(1):103-110. doi: 10.3233/NRE-182526.

  PMID: 30714980 BACKGROUND

• Alali D, Ballard K, Bogaardt H. Treatment Effects for Dysphagia in Adults with Multiple Sclerosis: A Systematic Review. Dysphagia. 2016 Oct;31(5):610-8. doi: 10.1007/s00455-016-9738-2. Epub 2016 Aug 4.

  PMID: 27488370 RESULT

• Bergamaschi R, Crivelli P, Rezzani C, Patti F, Solaro C, Rossi P, Restivo D, Maimone D, Romani A, Bastianello S, Tavazzi E, D'Amico E, Montomoli C, Cosi V. The DYMUS questionnaire for the assessment of dysphagia in multiple sclerosis. J Neurol Sci. 2008 Jun 15;269(1-2):49-53. doi: 10.1016/j.jns.2007.12.021. Epub 2008 Feb 15.

  PMID: 18280504 RESULT

• Ginocchio D, Alfonsi E, Mozzanica F, Accornero AR, Bergonzoni A, Chiarello G, De Luca N, Farneti D, Marilia S, Calcagno P, Turroni V, Schindler A. Cross-Cultural Adaptation and Validation of the Italian Version of SWAL-QOL. Dysphagia. 2016 Oct;31(5):626-34. doi: 10.1007/s00455-016-9720-z. Epub 2016 Jul 21.

  PMID: 27444734 RESULT

Related Links

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MeSH Terms

Conditions

Deglutition Disorders; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Maria Grazia Grasso, MD

  Fondazione Santa Lucia Rome Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a randomised double blind controlled study

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: October 1, 2021
• Study Start: January 21, 2022
• Primary Completion: April 15, 2023
• Study Completion: April 15, 2024
• Last Updated: September 25, 2025

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)