Oropharyngeal DysphagiaTENSVIRTNCT02170506
Effect of Sub-mental Sensitive Transcutaneous Electrical Stimulation on Pharyngeal Muscles Control : TENSVIRT Study
A study testing Urostim 2 stimulation in people with Oropharyngeal Dysphagia and Deglutition Disorders, run by University Hospital, Rouen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oropharyngeal Dysphagia, Deglutition Disorders
- What is being tested?
- Urostim 2 stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Sub-mental Sensitive Transcutaneous Electrical Stimulation on Pharyngeal Muscles Control
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.
Read more
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
- Being tested
- Urostim 2 stimulation
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urostim 2 stimulationDevice
Also called Device transcutaneous neuromuscular electrical 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.
| Study group | Role | What they receive |
|---|---|---|
| submental sensitive transcutaneous electrical stimulation. | Experimental | Each Healthy subjects will be his own witness. Urostim 2 stimulation Arm Receives: Device: Urostim 2 stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Secondary outcomes (1)
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
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oropharyngeal DysphagiaStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric VERIN, Professor, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02170506
- Sponsor's protocol ID
- 2013/176/HP
- Acronym
- TENSVIRT
- Status last verified
- Apr 2026
- First submitted
- 19 Mar 2014
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Cugy E, Leroi AM, Kerouac-Laplante J, Dehail P, Joseph PA, Gerardin E, Marie JP, Verin E. Effect of submental sensitive transcutaneous electrical stimulation on virtual lesions of the oropharyngeal cortex. Ann Phys Rehabil Med. 2016 Apr;59(2):94-9. doi: 10.1016/j.rehab.2015.10.010. Epub 2015 Dec 21.
PubMed 26717886
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sub-mental Sensitive Transcutaneous Electrical Stimulation on Pharyngeal Muscles Control
- ClinicalTrials.gov ID
- NCT02170506
- Acronym / sponsor ID
- TENSVIRT / 2013/176/HP
- Conditions
- Oropharyngeal Dysphagia, Deglutition Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 23 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| submental sensitive transcutaneous electrical stimulation. | Experimental | Device: Urostim 2 stimulationEach Healthy subjects will be his own witness. Urostim 2 stimulation Arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- Subjects with swallowing disorders
- Presence of psychiatric disorders
- Skin disorders
- Cardiac disorders (non controlled arrythmia, severe heart failure, presence of heart valve)
- Submental tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urostim 2 stimulationAlso: Device transcutaneous neuromuscular electrical stimulationSensory 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. | Device | submental sensitive transcutaneous electrical stimulation. |
Primary outcome
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
1 secondary outcome
variation of swallow reaction time
Time frame: 1 Month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Results publication: PubMed 26717886Cugy E, Leroi AM, Kerouac-Laplante J, Dehail P, Joseph PA, Gerardin E, Marie JP, Verin E. Effect of submental sensitive transcutaneous electrical stimulation on virtual lesions of the oropharyngeal cortex. Ann Phys Rehabil Med. 2016 Apr;59(2):94-9. doi: 10.1016/j.rehab.2015.10.010. Epub 2015 Dec 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric VERIN, Professor principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urostim 2 stimulation in people with Oropharyngeal Dysphagia and Deglutition Disorders, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in motor evoked potential amplitude (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02170506, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.