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NCT Number: NCT02170506

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

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).

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Key information

Conditions

Oropharyngeal Dysphagia Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UHRouen

Rouen, 76031, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Person under judicial protection
  • Person deprive of their liberty by judicial or administrative decision
  • Participating in a clinical trial within 4 weeks before the pre-inclusion visit

Treatment and study plan

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.

Other names: Device transcutaneous neuromuscular electrical stimulation

Primary outcomes

  1. Variation in motor evoked potential amplitude

    Time frame: 1 month

    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

Secondary outcomes

  1. variation of swallow reaction time

    Time frame: 1 Month

    highlighting a change in swallowing with videofluoroscopy studied with electrical stimulation. Secondary endpoints are :

    • modification of swallowing cortical area
    • variation of swallow reaction time on videofluoroscopy

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

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

Acronym: TENSVIRT

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 23, 2014
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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