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Trial record 42 of 51 for:    Benign Essential Blepharospasm

Cognitive Function and Emotional Possessing in Bilateral Facial Palsy

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ClinicalTrials.gov Identifier: NCT02179450
Recruitment Status : Completed
First Posted : July 1, 2014
Last Update Posted : July 1, 2014
Sponsor:
Information provided by (Responsible Party):
Kirsten Elwischger, MD, Medical University of Vienna

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.


Condition or disease
Intelligence Emotion

Study Type : Observational
Actual Enrollment : 84 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pilot Study Assessing Cognitive Function and Emotional Possessing in Patients With Bilateral Facial Palsy
Study Start Date : August 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. I-S-T-2000R- (intelligence-structure-test 2000R) [ Time Frame: up to four weeks ]

    Test to evaluate Intelligence

    • Subtest "Matrixes"
    • Subtest "Analogies"


Secondary Outcome Measures :
  1. Beck's depression-inventory-II [ Time Frame: up to four weeks ]
    Evaluation of depression (BDI-II; Hautzinger et al., 2009)

  2. Apathy Evaluation Scale [ Time Frame: up to four weeks ]
    Evaluation of apathy (AES; Luecken et al., 2006)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02179450


Locations
Austria
Department of Neurology, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Kirsten Elwischger, MD
Investigators
Principal Investigator: Eduard Auff, Prof., MD Department of Neurology, Medical University of Vienna

Publications:
Responsible Party: Kirsten Elwischger, MD, Dr. Kirsten Elwischger, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02179450     History of Changes
Other Study ID Numbers: Cognition_Facial palsy
First Posted: July 1, 2014    Key Record Dates
Last Update Posted: July 1, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Facial Paralysis
Bell Palsy
Mouth Diseases
Stomatognathic Diseases
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Facial Nerve Diseases
Cranial Nerve Diseases