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

NCT ID: NCT02170506

Last Updated: 2015-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2014-07-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

submental sensitive transcutaneous electrical stimulation.

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

Group Type: EXPERIMENTAL

Urostim 2 stimulation

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Device transcutaneous neuromuscular electrical stimulation

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric VERIN, Professor

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

UHRouen

Rouen, , France

Countries

France

Other Identifiers

2013/176/HP

Identifier Type: -

Identifier Source: org_study_id