Cognitive Function and Emotional Possessing in Bilateral Facial Palsy

June 30, 2014 updated by: Kirsten Elwischger, MD

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

84

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Department of neurology, Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability 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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
I-S-T-2000R- (intelligence-structure-test 2000R)
Time Frame: up to four weeks

Test to evaluate Intelligence

  • Subtest "Matrixes"
  • Subtest "Analogies"
up to four weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck's depression-inventory-II
Time Frame: up to four weeks
Evaluation of depression (BDI-II; Hautzinger et al., 2009)
up to four weeks
Apathy Evaluation Scale
Time Frame: up to four weeks
Evaluation of apathy (AES; Luecken et al., 2006)
up to four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kirsten Elwischger, MD

Investigators

  • Principal Investigator: Eduard Auff, Prof., MD, Department of neurology, Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

December 31, 2012

First Submitted That Met QC Criteria

June 30, 2014

First Posted (Estimate)

July 1, 2014

Study Record Updates

Last Update Posted (Estimate)

July 1, 2014

Last Update Submitted That Met QC Criteria

June 30, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cognition_Facial palsy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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