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

Sponsor
University Hospital, Rouen (Other)
Overall Status
Completed
CT.gov ID
NCT02170506
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
3
Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: Urostim 2 stimulation
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
Effect of Sub-mental Sensitive Transcutaneous Electrical Stimulation on Pharyngeal Muscles Control
Study Start Date :
Apr 1, 2014
Actual Primary Completion Date :
Jul 1, 2014
Actual Study Completion Date :
Jul 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: submental sensitive transcutaneous electrical stimulation.

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

Device: Urostim 2 stimulation
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Variation in motor evoked potential amplitude [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 Outcome Measures

    1. variation of swallow reaction time [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Subjects aged over 18 years

    2. Affilitation to social security scheme

    3. Registration in National register of people who participate in biomedical research

    4. Healthy volunteers who provided written informed consent

    Exclusion Criteria:

    1. Subjects with swallowing disorders

    2. Presence of psychiatric disorders

    3. Skin disorders

    4. Cardiac disorders (non controlled arrythmia, severe heart failure, presence of heart valve)

    5. Submental tumor

    6. Epilepsia, treated or untreated

    7. Presence of neurosurgical clip

    8. Suspicion of digestive fistula

    9. Presence of metal, pacemaker, defibrillator, pump treatment or neurostimulation

    10. Cannabis user, regular use of benzodiazepines

    11. Presence of chronic respiratory, neurological disease, ENT or gastroesophageal disease (cause potentially change swallowing)

    12. Contra-indication to MRI (claustrophobia, metal fragment, cardiac/ENT/neurological implantable device not MRI compatible, osteosynthesis prior to 1980)

    13. Subject reported against the use of Micropaque®

    14. Pregnant or nursing woman, or absence of contraception

    15. Poor understanding of French langage

    16. Person under judicial protection

    17. Person deprive of their liberty by judicial or administrative decision

    18. Participating in a clinical trial within 4 weeks before the pre-inclusion visit

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UHRouen Rouen France 76031

    Sponsors and Collaborators

    • University Hospital, Rouen

    Investigators

    • Principal Investigator: Eric VERIN, Professor, University Hospital, Rouen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Rouen
    ClinicalTrials.gov Identifier:
    NCT02170506
    Other Study ID Numbers:
    • 2013/176/HP
    First Posted:
    Jun 23, 2014
    Last Update Posted:
    Jan 22, 2015
    Last Verified:
    Jan 1, 2015
    Additional relevant MeSH terms:
    Deglutition Disorders

    Study Results

    No Results Posted as of Jan 22, 2015