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NCT Number: NCT02179450

Cognitive Function and Emotional Possessing in 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.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neurology, Medical University of Vienna

Vienna, State of Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. I-S-T-2000R- (intelligence-structure-test 2000R)

    Time frame: up to four weeks

    Test to evaluate Intelligence

    • Subtest "Matrixes"
    • Subtest "Analogies"

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Kirsten Elwischger, MD

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 1, 2014
Registry last updated
Jul 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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