NCT02179450

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 31, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
7 months until next milestone

First Posted

Study publicly available on registry

July 1, 2014

Completed
Last Updated

July 1, 2014

Status Verified

June 1, 2014

Enrollment Period

9 months

First QC Date

December 31, 2012

Last Update Submit

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

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Location

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: 20548056BACKGROUND
  • 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: 18485989BACKGROUND
  • 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: 18562330BACKGROUND
  • 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.

Study Officials

  • Eduard Auff, Prof., MD

    Department of Neurology, Medical University of Vienna

    PRINCIPAL INVESTIGATOR

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

Locations