Neuromuscular Electrostimulation in Multiple Sclerosis People With Dys
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
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Experimental: traditional dysphagia therapy plus Neuromuscular electrostimulation
Placebo
- Sham Comparator: Traditional dysphagia therapy plus sham Neuromuscular electrostimulation
What it measured
Main measures
change from American Speech-Language Hearing Association (ASHA) score baseline at 12 weeks
after 16 sessions of treatment and after 12 weeks from the end of treatment
Other measures (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
Quality of life (reported by participants)Change from Penetration and Aspiration Score at 12 weeks
after 16 sessions of treatment and after 12 weeks from the end of treatment
Change from Pooling score at 12 weeks
after 16 sessions of treatment and after 12 weeks from the end of treatment
Who could take part
MS (type not specified) · 18 and over
Show the full criteria
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
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.Results
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.Results
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.Background
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.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.
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History
Started
Jan 2022
Main results due
Apr 2023
Finished
Apr 2024