Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-28 @ 4:19 AM
Study NCT ID:
NCT02179450
Status:
COMPLETED
Last Update Posted:
2014-07-01
First Post:
2012-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Function and Emotional Possessing in Bilateral Facial Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-30', 'studyFirstSubmitDate': '2012-12-31', 'studyFirstSubmitQcDate': '2014-06-30', 'lastUpdatePostDateStruct': {'date': '2014-07-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'I-S-T-2000R- (intelligence-structure-test 2000R)', 'timeFrame': 'up to four weeks', 'description': 'Test to evaluate Intelligence\n\n* Subtest "Matrixes"\n* Subtest "Analogies"'}], 'secondaryOutcomes': [{'measure': "Beck's depression-inventory-II", 'timeFrame': 'up to four weeks', 'description': 'Evaluation of depression (BDI-II; Hautzinger et al., 2009)'}, {'measure': 'Apathy Evaluation Scale', 'timeFrame': 'up to four weeks', 'description': 'Evaluation of apathy (AES; Luecken et al., 2006)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Intelligence', 'Emotion']}, 'referencesModule': {'references': [{'pmid': '20548056', 'type': 'BACKGROUND', 'citation': 'Havas DA, Glenberg AM, Gutowski KA, Lucarelli MJ, Davidson RJ. Cosmetic use of botulinum toxin-a affects processing of emotional language. Psychol Sci. 2010 Jul;21(7):895-900. doi: 10.1177/0956797610374742. Epub 2010 Jun 14.'}, {'pmid': '18485989', 'type': 'BACKGROUND', 'citation': 'Alam M, Barrett KC, Hodapp RM, Arndt KA. Botulinum toxin and the facial feedback hypothesis: can looking better make you feel happier? J Am Acad Dermatol. 2008 Jun;58(6):1061-72. doi: 10.1016/j.jaad.2007.10.649.'}, {'pmid': '18562330', 'type': 'BACKGROUND', 'citation': 'Hennenlotter A, Dresel C, Castrop F, Ceballos-Baumann AO, Wohlschlager AM, Haslinger B. The link between facial feedback and neural activity within central circuitries of emotion--new insights from botulinum toxin-induced denervation of frown muscles. Cereb Cortex. 2009 Mar;19(3):537-42. doi: 10.1093/cercor/bhn104. Epub 2008 Jun 17.'}, {'pmid': '34496270', 'type': 'DERIVED', 'citation': 'Platho-Elwischger K, Schmoeger M, Willinger U, Abdel-Aziz C, Algner J, Pretscherer S, Auff E, Kranz G, Turnbull O, Sycha T. Cognitive Performance After Facial Botulinum Toxin Treatment in a Cohort of Neurologic Patients: An Exploratory Study. Arch Phys Med Rehabil. 2022 Mar;103(3):402-408. doi: 10.1016/j.apmr.2021.08.007. Epub 2021 Sep 5.'}]}, 'descriptionModule': {'briefSummary': 'Based on recent findings that botulinum toxin injections in the cranial muscles might reduce emotional processing (Havas 2011), an increasing number of popular newspaper tabloids are suggesting a negative effect on cognition. The underlying research articles address the "facial feedback hypothesis". The hypothesis indicates that expressive behaviour, including facial mimic expressions influences the subject\'s brain via feedback. (Alam 2008) Other systemic neurological diseases, e.g of inflammatory origin, may lead to temporary bilateral facial nerve palsy (BF). During recovery process, the palsy usually remits completely.\n\nThe effect of bilateral facial muscle palsy on cognition and emotional possessing has never been evaluated.\n\nThe results of this pilot study might provide new information about the effect bilateral facial palsy on emotional processing and cognition and the facial feedback hypothesis.\n\nThe aim of this controlled pilot study is to assess cognitive function and emotional processing in patients with bilateral facial palsy. In addition, differences in cognitive function and emotional processing in patients with different manifestations of dystonia should be evaluated.\n\nAccording to the facial feedback theory, paralysed mimic muscles might alter emotional processing. Therefore, investigators compare patients with bilateral facial muscle palsy and healthy controls. Investigators expect no influence of facial muscle palsy on cognitive functions in any of the tested groups; the investigators expect a mild impairment of emotional processing only in the patients group with bilateral facial muscle palsy (BEB and BF). In addition, the investigators expect no difference in emotional processing in patients with different manifestations of dystonia (BEB and CD) at remission. There might be a slight difference of emotional processing in patients with different manifestations of dystonia (BEB and CD) at time of prominent facial palsy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Two patient groups with bilateral facial palsy, 31 patients each (group A: BEB, , group C: BF), recruited from the Botulinum toxin outpatient's clinic and general outpatient's clinic of the Medical University of Vienna. Two control groups, 31 patients with CD, recruited from the Botulinum toxin outpatient's clinic of the Medical University of Vienna, and and 31 age-and education-matched HC, will perform neuropsychological testing of approximately 60 minutes duration at time of prominent facial palsy (baseline) and at remission (visit 1). HC age and education matched, will be tested twice.\n\nA total of 124 persons will be tested. All participants will sign an informed consent form. Group A: 31 BEB Group B: 31 CD Group C: 31 BF Group D: 31 HC", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients:\n\n* willing to participate in this pilot trial\n* bilateral facial palsy\n* age 18-80 years\n\nControl:\n\n* willing to participate in this pilot trial\n* age,\n* gender and\n* education (duration of school attendance) matched\n* and/or cervical dystonia\n\nExclusion Criteria:\n\n* neurological or psychiatric comorbidity\n* psychotropic drugs'}, 'identificationModule': {'nctId': 'NCT02179450', 'briefTitle': 'Cognitive Function and Emotional Possessing in Bilateral Facial Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Pilot Study Assessing Cognitive Function and Emotional Possessing in Patients With Bilateral Facial Palsy', 'orgStudyIdInfo': {'id': 'Cognition_Facial palsy'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Blepharospasm', 'description': 'Patients suffering from Blepharospasm'}, {'label': 'Cervical Dystonia', 'description': 'Patients suffering from cervical dystonia'}, {'label': 'Bilateral facial palsy', 'description': 'Patients suffering from bilateral facial palsy of inflammatory origin'}, {'label': 'Healthy Control', 'description': 'Control subjects'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'state': 'Vienna', 'country': 'Austria', 'facility': 'Department of Neurology, Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Eduard Auff, Prof., MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurology, Medical University of Vienna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kirsten Elwischger, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr. Kirsten Elwischger', 'investigatorFullName': 'Kirsten Elwischger, MD', 'investigatorAffiliation': 'Medical University of Vienna'}}}}