Cognitive Function and Emotional Possessing in Bilateral Facial Palsy

Emotion Clinical Trial

Official title:

Pilot Study Assessing Cognitive Function and Emotional Possessing in Patients With Bilateral Facial Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02179450
• Other study ID #: Cognition_Facial palsy
• Status: Completed
• Phase: N/A
• First received: December 31, 2012
• Last updated: June 30, 2014
• Start date: August 2012
• Est. completion date: December 2013

Study information

• Verified date: June 2014
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• neurological or psychiatric comorbidity

• psychotropic drugs

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Emotion
• Intelligence

Locations

Country	Name	City	State
Austria	Department of Neurology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Kirsten Elwischger, MD

Country where clinical trial is conducted

Austria, 

References & Publications (3)

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. Review. — View 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. — View Citation

Hennenlotter A, Dresel C, Castrop F, Ceballos-Baumann AO, Wohlschläger 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. Erratum in: Cereb Cortex. 2010 Jan;20(1):253. Baumann, Andres O Ceballos [corrected to Ceballos-Baumann, Andres O]. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	I-S-T-2000R- (intelligence-structure-test 2000R)	Test to evaluate Intelligence; Subtest "Matrixes"; Subtest "Analogies"	up to four weeks	No
Secondary	Beck's depression-inventory-II	Evaluation of depression (BDI-II; Hautzinger et al., 2009)	up to four weeks	No
Secondary	Apathy Evaluation Scale	Evaluation of apathy (AES; Luecken et al., 2006)	up to four weeks	No