Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 8:48 PM
Study NCT ID:
NCT07325604
Status:
RECRUITING
Last Update Posted:
2026-03-09
First Post:
2026-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Neuromuscular Electrical Stimulation on Unilateral Central Facial Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005158', 'term': 'Facial Paralysis'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2030-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-06', 'studyFirstSubmitDate': '2026-01-07', 'studyFirstSubmitQcDate': '2026-01-07', 'lastUpdatePostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'My Facial Quantification (MyFacialQ)', 'timeFrame': 'From enrollment to the end of treatment at four weeks"', 'description': 'MyFacialQ quantifies degree of unilateral facial palsy through video recordings of mimical exercises. The development and validation study for MyFacialQ is in review.'}], 'secondaryOutcomes': [{'measure': 'Iowa Oral Performance Instrument (IOPI)', 'timeFrame': 'From enrollment to the end of treatment at four weeks', 'description': 'Measurement of lip strength'}, {'measure': 'Facial Clinimetric Evaluation (FACE)', 'timeFrame': 'From enrollment to three months follow-up after the intervention', 'description': 'Patient reported outcome on facial palsy'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['NMES', 'Central facial palsy', 'Multicenter RCT', 'Stroke', 'Facial symmetry'], 'conditions': ['Facial Palsy', 'Stroke']}, 'descriptionModule': {'briefSummary': 'Background Central facial palsy (CFP) is a common condition in stroke, with an estimated prevalence of 45%. CFP can lead to facial asymmetry, problems with mouth closure and food processing, bite marks on the cheek, social isolation, and reduced quality of life. CFP is seen as an important area of rehabilitation, and training is therefore often carried out to reduce the consequences of CFP. In a recent systematic review conducted by the principal investigator, the results showed that very few studies have been conducted that have investigated the effect of training for CFP, and there is currently no scientific evidence to support the effect of the various training interventions.\n\nObjective To investigate the effect of Neuromuscular electrical stimulation (NMES) on facial symmetry compared to usual practice, in participants with CFP as a result of stroke.\n\nHypothesis: Participants who receive training with NMES together with usual training for facial paralysis have greater improvement in facial symmetry than participants who only receive usual training for facial paralysis.\n\nTrial design Randomized controlled trial (RCT) with a nested pilot trial. A pilot trial/RCT will be conducted in order to power calculation in an RCT. The protocol for the pilot trial and RCT will be the same, and participants from the pilot trial and their outcome data are thus expected to be included in the RCT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Central facial palsy\n* First time stroke\n* \\>=18 years\n* Able to provide written consent\n\nExclusion Criteria:\n\n* Not able to cooperate for mimical exercises\n* Contraindications for NMES\n* Admitted for three weeks assessment stay at the hospital'}, 'identificationModule': {'nctId': 'NCT07325604', 'briefTitle': 'Effect of Neuromuscular Electrical Stimulation on Unilateral Central Facial Palsy', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Effect of Neuromuscular Electrical Stimulation on Unilaterial Central Facial Palsy: An Assesorblinded Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '955087'}, 'secondaryIdInfos': [{'id': '2501205', 'type': 'OTHER', 'domain': 'Medical Research Ethics Committees'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NMES', 'description': 'NMES is provided as an add-on to usual care', 'interventionNames': ['Device: Neuromuscular electrical stimulation (NMES)', 'Other: Usual Care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care', 'description': 'This arm receives usual care of facial palsy without NMES. Usual care encompass mimical exercises, facio oral sensory input, and kinesio taping.', 'interventionNames': ['Other: Usual Care']}], 'interventions': [{'name': 'Neuromuscular electrical stimulation (NMES)', 'type': 'DEVICE', 'description': 'Electrical stimulation of facial muscles.', 'armGroupLabels': ['NMES']}, {'name': 'Usual Care', 'type': 'OTHER', 'description': 'This arm receives usual care of facial palsy without NMES. Usual care encompass mimical exercises, facio oral sensory input, and kinesio taping.', 'armGroupLabels': ['NMES', 'Usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8450', 'city': 'Hammel', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Jesper Fabricius, PhD', 'role': 'CONTACT', 'email': 'jesperjm@hotmail.com', 'phone': '+4578419051'}, {'role': 'CONTACT', 'email': 'jesperjm@hotmail.com'}, {'name': 'Jesper Fabricius, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hammel neurorehabilitation centre and university research clinic', 'geoPoint': {'lat': 56.25762, 'lon': 9.86316}}], 'centralContacts': [{'name': 'Jesper Fabricius, PhD', 'role': 'CONTACT', 'email': 'jesperjm@hotmail.com', 'phone': '+4578419051'}], 'overallOfficials': [{'name': 'Jesper Fabricius, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hammel Neurorehabilitation Centre and University Research Clinic & Department of clinical medicine, Aarhus University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD raw data is mainly video recordings, and these will not be shared. However aggregated measures from the video recordings may be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Danish Association of Occupational Therapist', 'class': 'OTHER'}, {'name': 'Hammel Neurorehabilitation Centre and University Research Clinic', 'class': 'OTHER'}, {'name': 'Hospital of Central Denmark Region, Denmark', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}