Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT01971320
Status:
TERMINATED
Last Update Posted:
2016-08-17
First Post:
2013-10-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Transcutaneous Electrical Stimulation in Post Stroke Dysphagia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'lack of recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-16', 'studyFirstSubmitDate': '2013-10-23', 'studyFirstSubmitQcDate': '2013-10-23', 'lastUpdatePostDateStruct': {'date': '2016-08-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of oropharyngeal dysphagia symptoms', 'timeFrame': 'Week 6', 'description': 'Evaluation of oropharyngeal dysphagia symptoms by questionnaire (dysphagia handicap index)'}], 'secondaryOutcomes': [{'measure': 'Evaluation of oropharyngeal dysphagia symptoms', 'timeFrame': 'Week 6', 'description': 'Evaluation of oropharyngeal dysphagia symptoms by videofluoroscopy and Swal-QoL questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Oropharyngeal Dysphagia', 'Deglutition Disorders']}, 'descriptionModule': {'briefSummary': 'Oropharyngeal dysphagia induces aspirations which could be responsible of aspiration pneumonia and denutrition. It could be present in the majority of central neurological disease (degenerative or vascular disease), which explains that it is the first case of mortality in stroke. Two pilot studies realised by our research group aimed to demonstrate that sensitive transcutaneous electrical stimulation could improve swallowing coordination and reduce aspirations. This technique could be used at home.\n\nThe aim of this study is to demonstrate that sensitive electrical stimulation could improve oropharyngeal dysphagia in hemispheric stroke patients. 118 patients should be included in seven centers. Sensitive electrical stimulation will be applied either as active stimulation, either as a placebo. Active electrical stimulation will be realised at 80 hz during 30 minutes, under motor threshold and above sensitive threshold. It will be administrated via surface electrodes over the hyoid bone. Patients will be separated by randomisation.\n\nPatients will be evaluated before and after 6 weeks of use. Methods will evaluation questionnaire, clinical examination and videofluoroscopy. The time of use will also be collected.\n\nWe wish to demonstrate that transcutaneous electrical stimulation is able to improve oropharyngeal dysphagia in stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 85 years\n* No contraindication to electrical stimulation\n* Oropharyngeal dysphagia from 8 weeks diagnosed by videofluorosocpy with penetration aspiration scale \\> 3 or a residue ≥ 50%\n* Due to an hemispheric stroke\n* Patients able to understand the videofluroscopy and questionnaires\n* For women in age of procreation, to have a contraception, a pregnacy test will be done if not\n* Able to swallow (a nasogastric tube is not a contraindication to participate)\n\nExclusion Criteria:\n\n* Pregnancy or breast feeding\n* Psychiatric illnes\n* Swallowing disorders before the stroke\n* Contraindication to electrical stimulation'}, 'identificationModule': {'nctId': 'NCT01971320', 'acronym': 'TENSDEG', 'briefTitle': 'Evaluation of Transcutaneous Electrical Stimulation in Post Stroke Dysphagia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Rouen'}, 'officialTitle': 'Evaluation of Transcutaneous Electrical Stimulation in Post Stroke Dysphagia', 'orgStudyIdInfo': {'id': '2013/002/HP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'active stimulation', 'description': 'sensitive electrical stimulation applied during meals with Urostim I for 6 weeks\n\nUrostim I stimulation will be done during meals for 6 weeks', 'interventionNames': ['Device: Urostim I stimulation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'fake stimulation', 'description': 'Urostim I stimulation will be done during meals for 6 weeks\n\nFake sensitive electrical stimulation applied during meals with modified Urostim I who not deliver stimulation for 6 weeks', 'interventionNames': ['Device: Urostim I stimulation']}], 'interventions': [{'name': 'Urostim I stimulation', 'type': 'DEVICE', 'description': 'Urostim I stimulation will be done during meals for 6 weeks', 'armGroupLabels': ['active stimulation', 'fake stimulation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bois-Guillaume', 'country': 'France', 'facility': 'Centre les Herbiers', 'geoPoint': {'lat': 49.4602, 'lon': 1.12219}}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'UH Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Limoges', 'country': 'France', 'facility': 'UH Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'city': 'Paris', 'country': 'France', 'facility': 'AP-HP Fernand WIDAL', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Rouen', 'country': 'France', 'facility': 'UH Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'UH Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Eric VERIN, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UH Rouen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Rouen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}