Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2025-12-27 @ 5:31 AM
Study NCT ID:
NCT04457492
Status:
TERMINATED
Last Update Posted:
2024-03-20
First Post:
2020-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Electrical Stimulation for Facial Muscles
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020330', 'term': 'Bell Palsy'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D005155', 'term': 'Facial Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'PI Relocation', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-18', 'studyFirstSubmitDate': '2020-06-08', 'studyFirstSubmitQcDate': '2020-06-30', 'lastUpdatePostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Lagophthalmos Over 14 weeks', 'timeFrame': 'Measured at week 0, 7 and 14', 'description': 'Change in ability to close eyelids, measured in mm'}, {'measure': 'Change in Elevation of Corner of Mouth Over 14 weeks', 'timeFrame': 'Measured at week 0, 7 and 14', 'description': 'Change in ability to raise corner of mouth, measured in mm'}, {'measure': 'Change House-Brackmann Scale Measurement Over 14 weeks', 'timeFrame': 'Measured at week 0, 7 and 14', 'description': 'The House-Brackmann facial nerve grading scale is a measure of facial nerve impairment. The scale ranges from values 1 to 6, with larger values indicating greater facial nerve impairment.'}, {'measure': 'FaCE Questionnaire', 'timeFrame': 'Administered at week 0, 7 and 14', 'description': "Patient-based instrument to measure both facial impairment and disability. This will be used to identify patient's perceived change in facial impairment for the duration of the study period."}, {'measure': 'Change in Facial Movements Over 14 weeks', 'timeFrame': 'Measured at week 0, 7 and 14', 'description': 'A video will be taken of the patient undergoing standard facial movements'}, {'measure': 'Study Interview', 'timeFrame': 'Administered at week 0, 7 and 14', 'description': 'A structured interview questionnaire administered by a study team member to identify any changes to the therapy that may be needed before further studies are conducted'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Facial Nerve Paralysis', 'Functional Electrical Stimulation', 'Rehabilitation'], 'conditions': ['Facial Nerve Paresis']}, 'descriptionModule': {'briefSummary': 'Partial or complete facial paralysis is the weakness of muscles of facial expression. Facial paralysis causes physical, social and emotional problems. Functional electrical stimulation (FES) for facial paralysis is a technique in which muscles are electrically stimulated, causing them to contract This study is designed to help patients with facial nerve weakness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients experiencing unilateral facial nerve paralysis Brackmann 5/6 or 6/6.\n\nExclusion Criteria:\n\n* History of epilepsy or seizures.\n* Individuals with metal orthopedic implants in the mouth (e.g. plates or screws).\n* Individuals suffering from fibromyalgia.\n* Individuals currently receiving any form of transcranial brain stimulation (e.g. rTMS, ECT, or MST).'}, 'identificationModule': {'nctId': 'NCT04457492', 'briefTitle': 'Functional Electrical Stimulation for Facial Muscles', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Applying Functional Electrical Stimulation to Facial Muscles After Acute Paralysis', 'orgStudyIdInfo': {'id': '19-5743'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acute Facial Nerve Injury with Intact Facial Nerve', 'description': '40 sessions of FES (in a 14 week period)\n\nAssessments will be taken during the beginning, middle, and end of each study arm.', 'interventionNames': ['Other: Application of FES to the Face']}, {'type': 'EXPERIMENTAL', 'label': 'Facial Nerve Grafting After Surgical Excision', 'description': '40 sessions of FES (in a 14 week period)\n\nAssessments will be taken during the beginning, middle, and end of each study arm.', 'interventionNames': ['Other: Application of FES to the Face']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care Group', 'description': 'No FES\n\nAssessments will be taken at the same intervals as the interventions group.'}], 'interventions': [{'name': 'Application of FES to the Face', 'type': 'OTHER', 'description': 'Functional electrical stimulation (FES) for facial paralysis is a technique in which muscles are electrically stimulated.', 'armGroupLabels': ['Acute Facial Nerve Injury with Intact Facial Nerve', 'Facial Nerve Grafting After Surgical Excision']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Douglas Chepeha, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}