Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02170506
Acronym
TENSVIRT
Enrollment
10
Registered
2014-06-23
Start date
2014-04-01
Completion date
2014-07-01
Last updated
2026-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deglutition Disorders, Oropharyngeal Dysphagia

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).

Interventions

DEVICEUrostim 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.

Sponsors

University Hospital, Rouen
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Variation in motor evoked potential amplitude1 monthOur 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

MeasureTime frameDescription
variation of swallow reaction time1 Monthhighlighting 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

Countries

France

Contacts

PRINCIPAL_INVESTIGATOREric VERIN, Professor

University Hospital, Rouen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 17, 2026