Effect of Sub-mental Sensitive Transcutaneous Electrical Stimulation on Pharyngeal Muscles Contro… (NCT02170506) | Clinical Trial Compass
CompletedNot Applicable
Effect of Sub-mental Sensitive Transcutaneous Electrical Stimulation on Pharyngeal Muscles Control : TENSVIRT Study
France10 participantsStarted 2014-04
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. Subjects with swallowing disorders
. Presence of psychiatric disorders
. Skin disorders
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.