Cognitive Function and Emotional Possessing in Bilateral Facial Palsy
Pilot Study Assessing Cognitive Function and Emotional Possessing in Patients With Bilateral Facial Palsy
1 other identifier
observational
84
1 country
1
Brief Summary
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. The effect of bilateral facial muscle palsy on cognition and emotional possessing has never been evaluated. The 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. The 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. According 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2012
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFirst Posted
Study publicly available on registry
July 1, 2014
CompletedJuly 1, 2014
June 1, 2014
9 months
December 31, 2012
June 30, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
I-S-T-2000R- (intelligence-structure-test 2000R)
Test to evaluate Intelligence * Subtest "Matrixes" * Subtest "Analogies"
up to four weeks
Secondary Outcomes (2)
Beck's depression-inventory-II
up to four weeks
Apathy Evaluation Scale
up to four weeks
Study Arms (4)
Blepharospasm
Patients suffering from Blepharospasm
Cervical Dystonia
Patients suffering from cervical dystonia
Bilateral facial palsy
Patients suffering from bilateral facial palsy of inflammatory origin
Healthy Control
Control subjects
Eligibility Criteria
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. A 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
You may qualify if:
- Patients:
- willing to participate in this pilot trial
- bilateral facial palsy
- age 18-80 years
- Control:
- willing to participate in this pilot trial
- age,
- gender and
- education (duration of school attendance) matched
- and/or cervical dystonia
You may not qualify if:
- neurological or psychiatric comorbidity
- psychotropic drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Neurology, Medical University of Vienna
Vienna, Vienna, 1090, Austria
Related Publications (4)
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: 20548056BACKGROUNDAlam 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: 18485989BACKGROUNDHennenlotter 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: 18562330BACKGROUNDPlatho-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.
PMID: 34496270DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Eduard Auff, Prof., MD
Department of Neurology, Medical University of Vienna
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Dr. Kirsten Elwischger
Study Record Dates
First Submitted
December 31, 2012
First Posted
July 1, 2014
Study Start
August 1, 2012
Primary Completion
May 1, 2013
Study Completion
December 1, 2013
Last Updated
July 1, 2014
Record last verified: 2014-06