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
Phase: NA
Conditions: Deglutition Disorders, Multiple Sclerosis
Sponsor: I.R.C.C.S. Fondazione Santa Lucia

To evaluate the activity and the efficacy of traditional swallowing therapy 
(TST) plus neuromuscular electrostimulation (NMES) vs TST plus sham- 
NMES in Multiple Sclerosis patients with dysphagia 
 
  
NCT05063708 
 
February 9 2024 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

To evaluate the activity and the efficacy of traditional swallowing therapy 
(TST) plus neuromuscular electrostimulation (NMES) vs TST plus sham- 
NMES in Multiple Sclerosis  patients with dysphagia 
 
MG Grasso1, G Brichetto 3, G Ferriero 4, F Patti 5, Marco Rovaris 6,  C Tassorelli 7,   C 
Solaro 2 
1 IRCCS Fondazione Santa Lucia (Rome Italy) 
2 CRRF "Mons. Luigi Novarese, Moncrivello (Vercelli, Italy) 
3  Italian Ms Foundation, (Genoa, Italy)  
4  IRCCS Maugeri (Pavia Italy)  
5 University of Catania (Italy) 
6 Scientific Institute Santa Maria Nascente Fondazione Don C. Gnocchi (Milan Italy) 
7 IRCCS Mondino Foundation and University of Pavia (Pavia, Italy) 
 
Abstract 
 
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 ( Fred)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. 
 
Introduction 
 
Recent studies has shown  that dysphagia in MS is more frequent than previously 
believed, the real prevalence ranging from 33 to 43%. (Solaro et al 2013) Dysphagia is a 
disabling, life-threatening symptom that can cause death in MS people through aspiration 
pneumonia. Dysphagia has also been reported in about 17% of patients with low disability 
(EDSS score lower than 2.5) (Abraham, et al 1997). These figures, which are based on 

clinical evaluations, are undoubtedly higher when the symptom is evaluated by means of 
instrumental investigations (Tassorelli, et al 2008). According to the De Pauw study (De 
Paw, et al2002), permanent dysphagia emerges in mildly impaired patients (EDSS 2-3), 
and becomes increasingly common as disability worsens, reaching a prevalence of 65% in 
the most severely disabled subjects (EDSS 8-9). Thus, diagnosis in the early stages may 
play an important role in limiting the consequences of this dysfunction. However, as 
patients themselves sometimes underestimate this symptom, diagnosis must be 
supported, as recently described in the literature, by functional tests and instrumental 
evaluations. A specific questionnaire (DYMUS: Dysphagia in Multiple Sclerosis) was 
published and validated for the assessment of dysphagia in MS. Its good internal 
consistency and the feasibility of administration has made it a reliable means to detect 
dysphagia in MS. In particular it consents to distinguish dysphagia to solids from 
dysphagia to liquids (Bergamaschi, et al.).2008). However, a more detailed and objective 
evaluation is needed to investigate specific deficits and to plan appropriate rehabilitation; 
the Fiberoptic Endoscopy Evaluation of Swallowing (FEES) may be used for this purpose. 
In the 20 years since these initial reports, the FEES has become a validated technique for 
the evaluation of pharyngeal swallowing (Leder, et al 2008). The swallowing disturbances 
in MS are characterised by impairment of the oral and pharyngeal phases. Abraham et al. 
found impairment of the upper oesophageal sphincter in 100% of a small MS population 
(Abraham et al.1997). Calcagno et al., using a mixed clinical and instrumental 
examination, subdivided their population into three groups according to the severity of 
dysphagia: severe, moderate and slight. Severe dysphagia group showed impairment of 
both oral and pharyngeal phases of swallowing, moderate dysphagia group showed motor 
impairment of the tongue, lips, velum or larynx, while the mild dysphagia group showed 
deficiency either of the velum or of the glottic closure. In the same paper, Calcagno et al. 
found that the compensatory strategies resolved dysphagia in about 94% of the cases (46 
pts. Out of 49) (Calcagno et al., 2009). These strategies help to redirect and improve the 
food flow, avoiding aspiration and reducing the risk of pneumonia, but patients remain 
dysphagic and always need to perform compensatory strategies. (De Angelis et al 2008; 
Inagaki et al 2009,) As far as we know, this is the only study evaluating the rehabilitative 
approach, but it was not a control study. The role of food was highlighted in a recent paper 
showing that the main effect of food hardness is a delay in oral ejection time, which 
strongly delays total swallowing time, whereas pharyngeal bolus transit is dependent on its 
viscosity (Taniguchi et al 2008, ). Recently, a pilot study (Frost, et al 2018) has shown as 
NMES could probably improve voice quality in MS patients: in fact, dysarthria has been 
proven to affect quality of life in MS patients (Piacentini, 2014). 
NMES is a form of muscle stimulation with short electrical pulses that is frequently used in 
physiotherapy to strengthen healthy muscles and has been well described for several 
decades. NMES is used with a variety of different parameters for different types of 
treatment, since muscle contraction depends on different electrical parameters. An 
increase in frequency   will result in an increased tension of the stimulated muscle, 
whereas increased intensity spreads current over a larger area, stimulating more motor 
units. Lastly, increasing the current duration causes more motor unit activation. NMES can 
be used for either muscle strengthening, retardation of atrophy or muscle re-education, 
and different stimulation parameters have to be chosen for each of these three 

applications of NMES. The use of NMES in dysphagia treatment is relatively new; the first 
study was published in 2001 (Freed, 2001). Although Logemann reported that the 
therapeutic effects of NMES still lacks convincing supporting evidence, (Logemann, et al 
2007), several studies have been carried out (Heijnen et al 2012, Kim et al 2017, Li et al 
2015, Langmore et al 2016, Shaw et al 2007). Research using NMES, including 
randomized controlled trials, has demonstrated functionally improved swallowing with 
subjects moving from modified diets to more normal diet and fluids when NMES is used in 
conjunction with traditional therapy, but not when used in isolation (Chen, et al 2016). 
Moreover, recent UK guidelines from the National Institute of Clinical Excellence (NICE) 
recognized the positive results from these trials and promoted a further research to 
support the routine clinical use (NICE, 2014). NMES has been used in a wide range of 
patients, suffering from diverse pathologies: from head and neck cancer, to post-stroke 
dysphagia, obtaining different results (Chen 2016; Frost, 2018). Although it has been 
hypothesized, that neuromuscular electrical stimulation might enhance muscle strength in 
weak and disused oro-pharyngeal muscles, its clinical effectiveness remains unclear. 
Regardless the mechanism of action, clinical results showed that NMES enhances 
laryngeal elevation ( Park et al 2009), reduces upper esophageal sphincter pressure (Heck 
et al 2012) and it enhances tongue base retraction during swallowing in health volunteers 
(Jungheim et al 2017). As reported by Oh (Oh et al 2007) and Hamdy (Hamdy et al 2000), 
the improvement of the swallowing function in stroke, after electrical stimulation is 
correlated with cortical reorganization, suggesting that multiple sessions of NEMS of the 
neck muscles could improve swallowing function also trough the recruitment of new 
cortical areas. 
NMES has poor been used in treating dysphagia in MS patients (Alali, 2016). A pilot study 
performed with pharyngeal electrical stimulation for dysphagia associated with MS showed 
an improvement in penetration and aspiration scale, suggesting a potential benefit for the 
treatment of this symptom (Restivo et al 2013) 
However, this type of treatment can be performed only in specialized centers and it is 
probably more invasive than NMES. In 2009, Bogaardt (Bogaardt et al 2009) conducted a 
Class IV trial with a sample of 25 patients with MS. The primary focus of the study was to 
examine the effects of NMES on pooling of saliva or liquid in the valleculae and pyriform 
sinuses. Six of the 25 patients had significant reduction in pooling of saliva in the pyriform 
sinuses, and 23 participants reported through a questionnaire that their swallowing had 
improved (Bogaardt, et al 2009). As far as we know, this is the unique paper focusing on 
the therapeutic effects of NMES in MS patients. Our research group recently published 
about the use of NMES in people with stroke and dysphagia. The methodology resulted 
safe with a good effectiveness in add on with traditional speech therapy. In fact, combined 
treatment seem to reduce the risk of penetration and aspiration in stroke dysphagic 
people. (Simonelli et al 2019). 
The aim of the study is to determine whether NMES added benefit to a therapy program 
comprised of standard swallowing exercises in dysphagic pwMS 
 
 
 
 

Materials and methods 
 
The research plan will be implemented within a multi-center collaboration. Each of the 8 
centers will recruit 17 inpatient and outpatient with a diagnosis of MS, according to revised 
McDonald criteria (Thompson et al 2018), with dysphagia. Each patient will be evaluated 
with a general and neurological evaluation scored according to the Expanded Disability 
Status Scale (EDSS) of Kurtzke and its functional systems.  
Inclusion criteria will be: 
1) Sex (both); 
2) Age (older than 18) 
3) Diagnosis: definite MS (Thompson et al 2018) 
4) 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 
5) ASHA<6 and DYMUS >2 
6) Novelty: subjects should not have been trained with dysphagia program in the last 6 
month 
7) Mini-Mental State Examination: > 24; 
 
Exclusion criteria will be: 
1) dysphagia related to other diseases 
2) presence of tracheal cannula 
3) local or general contraindications to the use of equipment for electrical muscle 
stimulation of the neck 
4) malignancies or acute inflammation in the anterior region of the neck. 
5) lack of collaboration due to mental impairment 
 
Baseline characteristics: 
At T0, a clinical and instrumental examination will be suggested, concerning: 
- the cognitive profile (Brief International Cognitive Assessment for MS); (Benedict et al 
2012) 
- the presence and severity of fatigue scored with Modified Fatigue Impact Scale; (Tellez 
et al 2005) 
- the presence and severity of depression (Beck depression Inventory); (Solaro et al 2016) 
- the motor performance with Timed 25 Foot walk Test ,Timed Up and Go, and 9 hole Peg 
Test (Gijbels et al 2012, Kragt et al 2006, Sebastião et al 2016, ); 
- the body mass index (kg/m2) and blood parameters (in particular proteins and albumin) 
will be examined in all of the patients, in order to define their nutritional state; 
- Mini Nutritional Assessment (Vellas et al , 2006). To verify the appropriate food calories 
intake  
-  the voice quality: (Frost, 2018). In order to carry out the speech analysis, the software 
PRAAT (a system for doing phonetics) was developed by Paul Boersma & David Weenink 
at the Phonetic Sciences department at the University of Amsterdam) will be adopted. 
As far as the dysphagia concerned, its presence and severity will be assessed using: 
- ASHA score, (American Speech –Language Hearing Association, 1998) performed by a 
speech therapist; 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. Swallowing is safe and efficient for all 
food consistencies. Compensatory strategies are effectively used when needed). 
 
A non instrumental evaluation will be used, due to its feasibility, by an examiner unaware 
of the research protocol. The assessment takes into consideration anamnesis regarding 
the swallowing problem, evaluation of the anatomy and functionality, of sensitivity and the 
reflexes, of the swallowing apparatus. Finally, the oral feeding test is performed, which 
evaluates the oral and pharyngeal phases of swallowing.  
- FEES,  performed  by a phoniatrician in a blinded way in order to verify: 1) rest status, with 
reports of possible secretions or food presence, particularly in the lower pharyngeal tract; 
2) preliminary report on: a) glottis enclosure ability (phonation) b) coordination between 
breathing and vocalization, c) ability and sensitivity of the cough reflex. 3) “dry” swallowing, 
with observation of the pushing-back movement of the tongue, the time for swallowing 
voluntary activation(pharyngeal phase), the research of larynx elevation and epiglottis 
basculatory movement; 4) proposal of food coloured with green of varying consistencies to 
test the swallowing act with determined quantities: a) liquid: a spoonful, i.e. 10 ml, 
repeated three times; b) semisolid (gelatine consistency):  a spoonful, i.e. 10 ml, repeated 
three times; c) solid: half a cracker, repeated with three bits. During each swallowing act, 
the observer will have to examine the same functions described above in point n. 3, and 
his/her attention will focus on premature falls of the bolus towards the pharynx, with or 
without penetration and/or aspiration; the word “premature” indicates that it is 
contemporary to the oral phase and is to be used to indicate the alimentary falls before the 
pharyngeal phase of swallowing; penetration and/or aspiration during the pharyngeal 
phase of swallowing; laryngeal 
penetration, defined as passage of material into the laryngeal vestibule above the vocal 
folds and aspiration, defined as passage of material under the level of 
the true vocal folds;  reports of the permanence of food and/or secretion in the lower tract 
of the pharynx after the pharyngeal phase of swallowing  (pharyngeal residue 
or pooling) and evidence of penetration and/or aspiration of this residual component; the 
occurrence, or absence, of the cough reflex as a consequence of penetration and/or 
aspiration.  
  
 
According to the FEES examination will be scored the severity of dysphagia through the 
Dysphagia Outcome and Severity Scale (DOSS Score) (O’Neil et al 1999).  We’ll also use 
the Penetration and Aspiration Scale (Rosembek et al, 1996) and the Pooling scale, able 
to evaluate  the excess residue in the pharynx and larynx. (Farneti et al 2014). The FEES 
will be record by video. 
- the DYMUS questionnaire (Bergamaschi et al., 2008) 
- the Swal-QOL. This is a 44-items questionnaire is a highly valid instrument for evaluating 
and has a very reliable shorten reproducibility (Ginocchio D et al 2016). Its 11 subscales 
represents the different aspects of quality of life. The minimum and maximum score per 
subscale ranges from 0 to 100, indicating extremely impaired quality of life versus no 
impairment experienced by the individual;  

- Visual Analogue Scale (VAS) for dysphagia: self-assessment of dysphagia severity will 
be rated from 0 (none) to 10 (worst imaginable) scale. Respondents will be classified as 
having no dysphagia (score 0), mild dysphagia (scores 1-4), moderate dysphagia (scores 
5-6) and severe dysphagia (scores 7-10); 
- the meal time. 
-CGI (Clinical Global Impression Scale) scale for evaluating clinical changes after 
treatment  (Busner et al 2007) 
 
Two Speech Language Pathologists (SLPs) trained in dysphagia management  will be 
involved: one, as evaluating speech therapist, will be blind on the NMES treatment and the 
other one as a treating speech therapist. 
As far as the dysphagia concerned, patients will be considered dysphagic according to 
ASHA (score<6) and  DYMUS (score >2). 
The NICE guidelines (NICE 2014) identified from the literature a number of possible 
adverse events for NMES, which they classified under Safety section.  
Those deemed likely were burning sensation, skin irritation or soreness beneath the 
electrodes and coughing or expectoration, neck or jaw pain and increasing severity of 
dysphagia. Incidences of these events were recorded during the NMES therapy. The 
therapists who delivered the NMES therapy were also asked to record any other adverse 
reactions. In addition, therapists were asked to record whether the adverse reaction was 
resolved by repositioning the electrodes. 
Finally, the speech and language therapists were asked to note whether there was any 
change in the quality of the voice as a result of the NMES, as previous research has 
shown (Frost, 2018). 
The training will consist of 16 sessions. After 8 (T1) every patient will be examined using: 
ASHA scale; VAS for dysphagia and meal time. After 16 (T2) sessions, every patient will 
be examined with both clinical and  instrumental examinations; after 12 weeks (T3) from 
the end of treatment every patient will undergo clinical evaluations. At T3 the CGI will also 
be submitted to the pwSM caregivers 
 
Rehabilitation treatment 
According to the presence of dysphagia, scored as previously described by ASHA and 
DYMUS scales, were estimate that, we can enrol 17 pwMS for each center.. The 
candidates will be randomly allocated (according to 2 blocked randomization lists, 
generated electronically by www.random.org) in two groups numbered consecutively and 
equal numbers will be allocated to the intervention group “standard rehabilitative treatment 
plus neuromuscular electrostimulation”   (SRT-NMES), odd numbers to the control group 
“standard rehabilitative treatment plus Sham (SRT-S). Randomization will be done by 
single center.  
Both SRT-NMES and SRT-S groups will be received 16  sessions of  traditional dysphagia 
therapy according to their degree of dysphagia,  contemporary associated with Sham or 
NMES, 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.  
During the study period, steroids will not be permitted. 

 Patients who will experience relapses during the study period will be considered as drop-
out. 
  
 
Traditional dysphagia therapy 
The training will be performed by expert speech  therapists. Traditional dysphagia therapy 
(TDT) involved orofacial, lingual, and laryngeal motor exercises, including progressive 
resistance training, combination of lingual strengthening exercises, laryngeal adduction-
elevation exercises, effortful swallow manoeuvre, Mendelsohn manoeuvre (Mendelsohn et 
al 1987), Masako manoeuvre (Fujiu et al 1996) and Shaker exercises ( Shaker et al 1997). 
Compensatory swallowing strategies included various modifications of head, neck, and 
body postures and adjustment of food/liquid temperature, viscosity, and volume. It may be 
necessary to whisk food completely or partially, often adding a thickening liquid in drinks to 
allow an adequate water intake for nutritional support. 
(Gonzales-Fernandez et al 2008). The choice of specific positioning strategies and 
swallowing manoeuvres or exercises 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 .  
 
Neuromuscular electrostimulation (NMES) 
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. The 
training was given according to the manual of the manufacturer, the VitalStim certification 
course (http://www.vitalstim.com). 
 
Skin preparation and electrode placement will be in accordance with the manufacturer’s 
instructions. 
 Channel 1 is horizontally immediately above thyroid notch. Channel 2 is parallel, below 
notch. 
Having applied the electrodes, the amplitude of each channel of the stimulator will be 
increased and the subject will identify when they will be able just feel it. The amplitude will 
be then further 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. In “sham” group the same electrodes will be 
positioned. 
To maintain the double-blind study, the electrodes in the "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) until the patient begins to feel a slight tingling, current unable to perform muscle 
contraction. (Park J. S. et Al). 
 

During electrical stimulation, traditional swallowing therapy will be carried out, by a trained 
speech therapist. 
Before the study starting, the team of the 8 Centres, reached a consensus for the 
administration of clinical scales and how to score the FEES  findings. 
 
Briefly: 
 
Subjects: 
136 clinically definite MS subjects, both outpatients and inpatients (see inclusion and 
exclusion criteria below). Each patient will be informed on overall requirements of the 
study, and his/her written consent will be obtained 
Primary Outcome: 
The first aim of this study is to determine whether NMES adds benefit to a speech therapy 
traditional program. Performance between the groups will be compared at completion of 
treatment, after adjustment for baseline differences. 
The mean difference at ASHA score between SRT-S  vs SRT-NMES will represent the 
primary outcome. 
Secondary outcome will be the differences obtained at To-T2 and T0-T3 in the two groups 
in DYMUS scale,FESS/DOSS score, the MNA, the Swallowing Quality of life 
questionnaire, Penetration and Aspiration Score, the Visual Analogue Scale and the 
Pooling score. 
Hypothesizing a response to treatment in the 30% of the SHAM group and in 60% of 
active NMSE a sample size of 56 subjects for each group provides a power of 0.9 and a 
significance level of 5%. (h = 0.6128748, n =55.94774, sig.level = 0.05, power = 0.9, 
alternative = two.sided) 
We estimate we could have a dropout of approximately 10-15%. In this light we decided to 
enrol 136 pwMS (17 for each center) Baseline characteristics and comparability of the two 
treatment groups will be assessed by the two samples t-test for continuous variables and 
by chi-square or Fisher’s exact test for categorical variables. To address the first aim of the 
study, will be used analysis of covariance comparing changes in study outcomes from 
baseline to T2 adjusting for differences in baseline measures of swallow performance, diet 
and quality of life across the two treatment arms. To evaluate the differences intra-group, 
we will performed longitudinal analyses using general linear models for repeated 
measures of outcome data collected at baseline to T2 . 
 
Italian MS Society Research Foundation is funding the study 
(Grant No 2019/R –Multi/ 005) 
 
 
 
 
 

References 
Alali D1, Ballard K2, 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. 
American Speech-Language Hearing Association. National Outcomes Measurements 
System (NOMS): Adult Speech-Language Pathology Training Manual. Rockville, Md: 
American Speech-Language Hearing Association; 1998 
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. Epub 2008 Feb 15. 
 
Blumfeld L., Hahn Y., LePage A., Leonard R., Belafsky P.C: Transcutaneous electrical 
stimulation versus traditional dysphagia therapy: a a nonconcurrent cohort study . 
Otolaryngology Head and neck surgery 2006; 135: 754-757 
Bogaardt H, van Dam D, Wever NM, Bruggeman CE, Koops J, Fokkens WJ. Use of 
neuromuscular electrostimulation in the treatment of dysphagia in patients with multiple 
sclerosis. Ann Otol Rhinol Laryngol. 2009 Apr;118(4):241-6 
Busner J, Targum SD, MD The Clinical Global Impressions Scale: Applying a Research 
Tool in Clinical Practice. Psychiatry. 2007 Jul;4(7):28-37 
De Pauw A, Dejaeger E, D'hooghe B, Carton H.Clin Neurol Neurosurg. Dysphagia in 
multiple sclerosis. 2002; 104: 345-351. 
Farneti D, Fattori B, Nacci A, Mancini V, Simonelli M, Ruoppolo G, Genovese E. The 
Pooling-score (P-score): inter- and intra-rater reliability in endoscopic assessment of the 
severity of dysphagia. Acta Otorhinolaryngol Ital. 2014: 34; 105-110. 
Freed ML, Freed L, Chatburn RL, Christian M. Electrical stimulation for swallowing 
disorders caused by stroke. Respir Care 2001;46:466-74. 
Frost J, Robinson HF, Hibberd J. A comparison of neuromuscular electrical stimulation 
and traditional therapy, versus traditionaltherapy in patients with longstanding dysphagia. 
Curr Opin Otolaryngol HeadNeck Surg. 2018; 26: 167-173. 
Fujiu M, Logemann JA: Effect of a tongue-holding maneuver on posterior pharyngeal wall 
movement during deglutition. Am J Speech Lang Pathol 1996;5:25-30. 
Ginocchio D, Alfonsi E, Mozzanica F, Accornero AR, Bergonzoni A, Chiarello G, De Luca 
N, Farneti D, M Simonelli, Calcagno P, Turroni V, Schindler A., Cross-Cultural Adaptation 
and Validation of the Italian Version of SWAL-QOL. Dysphagia. 2016; 31: 626-34. 
Guan XL, Wang H, Huang HS, Meng L. Prevalence of dysphagia in multiple sclerosis: a 
systematic review and meta-analysis. Neurol Sci. 2015; 36: 671-681. 

Hamdy S1, Rothwell JC, Aziz Q, Thompson DG. Organization and reorganization of 
human swallowing motor cortex: implications for recovery after stroke. Clin Sci (Lond). 
2000 Aug;99(2):151-7. 
Inagaki D, Miyaoka Y, Ashida I, Yamada Y.Influence of food properties and body position 
on swallowing related muscle activity amplitude. J Oral Rehabil. 2009 Mar;36(3):176-83. 
Leder SB, Murray JT. Fiberoptic endoscopic evaluation of swallowing. Phys Med Rehabil 
Clin N Am. 2008Nov;19(4):787-801, viii-ix. 
Logemann JA. The effects of VitalStim on clinical and research thinking in dysphagia. 
Dysphagia. 2007; 22: 11-12. 
Li L, Li Y, Huang R, Yin J, Shen Y, Shi J. The value of adding transcutaneous 
neuromuscular electrical stimulation (VitalStim) to traditional therapy for post-stroke 
dysphagia: a randomized controlled trial. Eur J PhysRehabil Med. 51: 2015; 71-78. 
O'Neil KH, Purdy M, Falk J, Gallo L. The Dysphagia Outcome and Severity Scale. 
Dysphagia. 1999; 14: 139-145. 
Park J.S., Oh D.H., Hwang  N.K., Lee J.H.: Effects of neuromuscular electrical stimulation 
combined with effortful swallowing on post-stroke oropharyngeal dysphagia: a randomised 
controlled trial. Journal of oral Rehabilitation 2016; 43:426-434. 
Piacentini V, Mauri I, Cattaneo D, Gilardone M, Montesano A, Schindler A. Relationship 
between quality of life and dysarthria in patients with multiple sclerosis. Arch Phys Med 
Rehabil. 2014: 95; 2047-2054 
Restivo DA, Casabona A, Centonze D, Marchese-Ragona R, Maimone D, Pavone A. 
Pharyngeal electrical stimulation for dysphagia associated with multiple sclerosis: a pilot 
study. Brain Stimul. 2013; 6: 418-423. 
Ricci Maccarini A, Filippini A, Padovani D, Limarzi M, Loffredo M, Casolino D. Clinical non-
instrumental evaluation of dysphagia. Acta Otorhinolaryngol Ital. 2007; 27: 299-305. 
 
Sebastião E, Sandroff BM, Learmonth YC, Motl RW. Validity of the Timed Up and Go Test 
as a Measure of Functional Mobility in Persons With Multiple Sclerosis. Arch Phys Med 
Rehabil. 2016; 97: 1072-1077. 
 
Shaker R, Kern M, Bardan E, Taylor A, Stewart ET, Hoffmann RG, Arndorfer RC, 
Hofmann C, Bonnevier J:Augmentation of deglutitive upper esophageal sphincter opening 
in the elderly by exercise. Am J Physiol 1997;272:G1518-G1522. 
 
Shaw GY, Sechtem PR, Searl J, Keller K, Rawi TA, Dowdy E. Transcutaneous 
neuromuscular electrical stimulation (VitalStim) curative therapy for severe dysphagia: 
myth or reality? Ann Otol Rhinol Laryngol. 2007; 116: 36-44. 

 
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.   
 
Solaro C, Rezzani C, Trabucco E, Amato MP, Zipoli V, Portaccio E, Giannini M, Patti F, 
D'Amico E, Frau J, Lorefice L, Bonavita S, Della Corte M, Grasso MG, Finamore L, Ghezzi 
A, Annovazzi P, Rottoli M, Gasperini C, Restivo D, Maimone D, Rossi P, Stromillo ML, 
Bergamaschi R. Prevalence of patient reported dysphagia in multiple sclerosis patients: an 
Italian multicenterstudy (using the DYMUS questionnaire). J Neurol Sci. 2013; 15: 94-97. 
Solaro C, Trabucco E, Signori A, Martinelli V, Radaelli M, Centonze D, Rossi S, Grasso 
MG, Clemenzi A, Bonavita S, D'Ambrosio A, Patti F, D'Amico E, Cruccu G1, Truini 
ADepressive Symptoms Correlate with Disability and Disease Course in Multiple Sclerosis 
Patients: An Italian Multi-Center Study Using the BeckDepression Inventory. PLoS One. 
2016; 15: 11. 
Sun SF, Hsu CW, Lin HS, Sun HP, Chang PH, Hsieh WL, Wang JL. Combined 
neuromuscular electrical stimulation (NMES) with fiberoptic endoscopic evaluation of 
swallowing (FEES) and traditional swallowing rehabilitation in the treatment of stroke-
related dysphagia. Dysphagia. 2013; 28: 557-566. 
Taniguchi H, Tsukada T, Ootaki S, Yamada Y, Inoue M. Correspondence between food 
consistency and suprahyoid muscle activity, tongue pressure, and bolus transit times 
during the oropharyngeal phase of swallowing. J Appl Physiol. 2008 Sep;105(3):791-9. 
Epub 2008 Jun 12. 
Tassorelli C, Bergamaschi R, Buscone S, Bartolo M, Furnari A, Crivelli P, Alfonsi E, 
Alberici E, Bertino G,Sandrini G, Nappi G. Dysphagia in multiple sclerosis: from 
pathogenesis to diagnosis. Neurol Sci. 2008; 29:360-363. 
Téllez N, Río J, Tintoré M, Nos C, Galán I, Montalban X. Does the Modified Fatigue Impact 
Scale offer morecomprehensive assessment of fatigue in MS? Mult Scler. 2005; 11: 198-
202. 
Thompson AJ, Banwell BL, Barkhof F, Carroll WM, Coetzee T, Comi G, Correale J, 
Fazekas F, Filippi M, Freedman MS, Fujihara K, Galetta SL, Hartung HP, Kappos L, Lublin 
FD, Marrie RA, Miller AE, Miller DH, Montalban X, Mowry EM, Sorensen PS, Tintoré M, 
Traboulsee AL, Trojano M, Uitdehaag BMJ, Vukusic S, Waubant E, Weinshenker BG, 
Reingold SC, Cohen JA. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald 
criteria.Lancet Neurol. 2018 Feb;17(2):162-173. doi: 10.1016/S1474-4422(17)30470-2. 
Epub 2017 Dec 21. Review 
Vellas B, Villars H, Abellan G et al., Overview of the MNA® – It’s history and challenges., 
JNutr Health Aging 2006;10:455-465.