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

Deglutition Disorders Clinical Trial

— TENSVIRT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02170506
• Other study ID #: 2013/176/HP
• Status: Completed
• Phase: N/A
• First received: March 19, 2014
• Last updated: January 21, 2015
• Start date: April 2014
• Est. completion date: July 2014

Study information

• Verified date: January 2015
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Deglutition Disorders
• Oropharyngeal Dysphagia

Intervention

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.

Locations

Country	Name	City	State
France	UHRouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	variation of swallow reaction time	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	1 Month	No