Effect of Sub-mental Sensitive Transcutaneous Electrical Stimulation on Pharyngeal Muscles Control : TENSVIRT Study

NCT02170506 | Completed

• 1 other identifier: 2013/176/HP
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Swallowing is a complex phenomenon that allows oral feeding while protecting the airway. It involves many brain areas, including primary motor and sensory areas. Its dysfunction, called oropharyngeal dysphagia is present in approximately 60% of patients with a stroke. In this case, it is conventionally translated by a swallow response time delay of the swallowing reflex. Pathophysiology of dysphagia is explained by impairment of the dominant swallowing, function that representation center is bi-hemispheric but asymmetric (Hamdy, 1997). Half of patients with a stroke supra-tentoriel with oropharyngeal dysphagia (about 55 % of strokes) regain normal swallowing in a few weeks ( Barer, 1989). Mechanisms that determine the recovery appear to be related to a reorganization of the motor cortex intact. Patients who retain disorders are those who have not cortical reorganization. With this in mind a team used different methods known to modulate brain plasticity, which electrotherapy with an application endo- pharyngeal sensory threshold. This stimulation increases the excitability of the cortico- bulbar reflex, which improves swallowing function in the clinical application. The hypothesis of this work is that the transcutaneous electrical stimulation applied submental, noninvasive technique, would also have an impact on cortical plasticity may explain the improved coordination of swallowing observed in earlier studies (Verin , 2011) ( Gallas , 2010).

Conditions

Oropharyngeal Dysphagia; Deglutition Disorders

Outcome Measures

Primary Outcomes (1)

• Variation in motor evoked potential amplitude

  Our aim was to show that submental sensitive transcutaneous electrical stimulation (SSTES) can modified swallowing function. Primary endpoint is change in motor evoked potential amplitude after submental transcutaneous electrical stimulation

  1 month

Secondary Outcomes (1)

• variation of swallow reaction time

  1 Month

Study Arms (1)

submental sensitive transcutaneous electrical stimulation.

EXPERIMENTAL

Each Healthy subjects will be his own witness. Urostim 2 stimulation Arm

Device: Urostim 2 stimulation

Interventions

Urostim 2 stimulation DEVICE

Sensory transcutaneous electrical stimulation will be started for a period of 20 minutes. It is applied by means of two surface electrodes placed under chin stimulation of both sides of the center line of the preceding side. Sensory transcutaneous electrical stimulation will inhibit the cerebral control of swallowing.

Also known as: Device transcutaneous neuromuscular electrical stimulation

submental sensitive transcutaneous electrical stimulation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged over 18 years
• Affilitation to social security scheme
• Registration in National register of people who participate in biomedical research
• Healthy volunteers who provided written informed consent

You may not qualify if:

• Subjects with swallowing disorders
• Presence of psychiatric disorders
• Skin disorders
• Cardiac disorders (non controlled arrythmia, severe heart failure, presence of heart valve)
• Submental tumor
• Epilepsia, treated or untreated
• Presence of neurosurgical clip
• Suspicion of digestive fistula
• Presence of metal, pacemaker, defibrillator, pump treatment or neurostimulation
• Cannabis user, regular use of benzodiazepines
• Presence of chronic respiratory, neurological disease, ENT or gastroesophageal disease (cause potentially change swallowing)
• Contra-indication to MRI (claustrophobia, metal fragment, cardiac/ENT/neurological implantable device not MRI compatible, osteosynthesis prior to 1980)
• Subject reported against the use of Micropaque®
• Pregnant or nursing woman, or absence of contraception
• Poor understanding of French langage

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

UHRouen

Rouen, 76031, France

Location

Related Publications (1)

• Cugy E, Leroi AM, Kerouac-Laplante J, Dehail P, Joseph PA, Gerardin E, Marie JP, Verin E. Effect of submental sensitive transcutaneous electrical stimulation on virtual lesions of the oropharyngeal cortex. Ann Phys Rehabil Med. 2016 Apr;59(2):94-9. doi: 10.1016/j.rehab.2015.10.010. Epub 2015 Dec 21.

  PMID: 26717886 RESULT

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Eric VERIN, Professor

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2014
• First Posted: June 23, 2014
• Study Start: April 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

FR (1)