[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633632":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":25,"responsibleParty":43,"collaborators":25,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":47,"sex":53,"minAge":54,"maxAge":25,"enrollmentInfo":55,"targetDuration":25,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":67,"whyStopped":25,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":25},{"fullName":5,"class":6},"Hopital Forcilles","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo Neuromuscular Electrical Stimulation (Placebo NMES)","PLACEBO_COMPARATOR","Patients included in the control group will receive standard care and the control intervention. The Neuro Muscular Electrical Stimulation (NMES) will be applied through 2 pairs of electrodes to the anterior surface of the neck. The same frequency and pulse duration will be used. The intensity will be increased until a vibration\u002Ftingling sensation perceptible by the patient is produced. The device will then be turned off.",[13],"Procedure: Placebo Neuromuscular Electrical Stimulation (Placebo NMES)",{"label":15,"type":16,"description":17,"interventionNames":18},"Neuromuscular Electrical Stimulation (NMES)","EXPERIMENTAL","The patient is comfortably positioned on their back, with the backrest at a 45° incline. Neuromuscular electrical stimulation (NMES) is applied through two pairs of electrodes placed on the front of the neck: one pair on the supra-hyoid muscles and the other on the infra-hyoid muscles. The electrodes are positioned using anatomical landmarks of the hyoid bone and the mandible. A current of 80 Hz with a pulse duration of 700 µs is applied to induce a muscle contraction. The treatment begins at least 72 hours after the tracheotomy and lasts for 21 days, with daily 30-minute sessions, 5 days a week. The treatment is performed once per day.\n\nLet me know if you need further adjustments or explanations!",[19],"Procedure: Neuromuscular Electrical Stimulation (NMES)",[21,26],{"type":22,"name":15,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","The patient will be comfortably positioned on their back, with the backrest inclined at 45°.\n\nNMES will be applied via two pairs of electrodes on the anterior neck. One pair of electrodes will be placed on the suprahyoid muscles and the other on the infrahyoid muscles.\n\nThe treatment begins at least 72 hours after the tracheotomy and lasts for 21 days, with daily 30-minute sessions, five days per week. The treatment is administered once per day. Each department is encouraged to identify a time slot to facilitate the organization of care and avoid non-completion of the treatment.\n\nThe duration of the session and the frequency of the intervention's application were chosen based on data from a recent systematic review of randomized controlled trials comparing the effectiveness of NMES versus conventional treatment. The included studies mostly had session durations around 30 minutes, 2 to 5 times per week, for a period of 2 to 6 weeks.",[15],null,{"type":22,"name":9,"description":27,"armGroupLabels":28,"otherNames":25},"NMES will be applied via two pairs of electrodes on the anterior neck.\n\nTwo electrodes will be placed above the hyoid bone, on either side, between the hyoid bone and the mandible. The other two electrodes will be placed on either side of the thyroid cartilage.\n\nThe patient will also be comfortably positioned in a supine position, with the backrest inclined at 45°. The same frequency and pulse duration will be used. The intensity will be increased until the patient perceives a vibrating\u002Ftingling sensation. The device will then be turned off.\n\nThe control intervention begins at least 72 hours after the tracheotomy and lasts for 21 days, with daily 30-minute sessions, five days per week.\n\nThe treatment is administered once per day at a time slot chosen by each center.",[9],[30],{"name":31,"affiliation":5,"role":32},"Carlos Diaz Lopez","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"Aymeric PhD LE NEINDRE","CONTACT","+33160646093","aleneindre@cognacq-jay.fr",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},"Andreia GOMES LOPES","+33160646293","alopes@cognacq-jay.fr",{"type":44,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100633632","effectiveness-of-transcutaneous-nmes-as-an-adjunct-for-swallowing-disorders-in-tracheotomized-patients-100633632",false,"NCT07529210","Effectiveness of Transcutaneous NMES as an Adjunct for Swallowing Disorders in Tracheotomized Patients","Evaluation of the Effectiveness of Transcutaneous Neuromuscular Electrical Stimulation as an Adjunct to Standard Treatment for Swallowing Disorders in Tracheotomized Patients Following Prolonged Mechanical Ventilation Weaning","SWALEC","Inclusion Criteria:\n\n* Hospitalized in intensive care units, post-ICU rehabilitation, or weaning and rehabilitation services;\n* Presence of a tracheostomy for more than 72 hours due to difficult mechanical ventilation weaning;\n* Diagnosis of swallowing disorders (swallowing fiberoscopy);\n* Patient aged at least 18 years at the time of inclusion;\n* Affiliated to a social security scheme or beneficiary of such a scheme;\n* Written, free and informed consent of the patient or their next of kin.\n\nExclusion Criteria:\n\n* Contra- indication to cervical NMES;\n* History of swallowing disorders;\n* Patient with a spinal cord injury above C5 level;\n* History of head and neck cancer;\n* Person under legal protection measures;\n* Patient under guardianship or conservatorship;\n* Known pregnancy;\n* Limitation of care.","ALL","18 Years",{"count":56,"type":57},238,"ESTIMATED","INTERVENTIONAL",[60],"NA","Dysphagia can reach a prevalence of up to 80% in intensive care patients. The implementation or prolonged presence of medical devices such as the intubation tube, tracheostomy, or nasogastric tube alters the physiology of swallowing and causes local injuries at several levels. Additionally, certain medical treatments impair swallowing physiology and the patient's alertness, further promoting the development of these disorders.\n\nManagement of dysphagia involves two main types of strategies: adaptive or compensatory maneuvers and rehabilitation techniques such as: performing praxis or swallowing exercises; physical stimulation (tactile or thermal); transcranial stimulation (electrical or magnetic); and finally, pharyngeal or transcutaneous electrical stimulation (NMES).\n\nPatients hospitalized in intensive care often present with altered levels of alertness, asynchronous ventilation and swallowing, and reduced motor capabilities, making it difficult to perform techniques like praxis, food trials, or resistance swallowing exercises. NMES does not require active patient cooperation or the permanent presence of the therapist during the stimulation session, thus increasing the intensity of dysphagia rehabilitation and the early implementation of treatment in these patients, complementing conventional rehabilitation. Muscle and sensory stimulation through the application of NMES can help increase the strength of the muscles involved in swallowing and improve sensory capabilities. However, its effects have not yet been evaluated in tracheostomized patients undergoing weaning from prolonged mechanical ventilation.",[63,64],"Dysphagia","NeuroMuscular Electrical Stimulation",[66],"Deglutition","NOT_YET_RECRUITING","2026-04-09",{"date":70,"type":71},"2026-04-14","ACTUAL",{"date":73,"type":57},"2026-03-26",{"date":75,"type":57},"2028-06-30",{"name":5,"class":6}]