IntelligenceNCT02179450
Cognitive Function and Emotional Possessing in Bilateral Facial Palsy
An observational study of Intelligence and Emotion, run by Kirsten Elwischger, MD at 1 site in Austria.
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". Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Intelligence, Emotion
- How many people
- 84 participants
- Where
- 1 siteAustria
- Study dates
- Aug 2012to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Patients:
- willing to participate in this pilot trial
- bilateral facial palsy
- age 18-80 years
- Control:
- willing to participate in this pilot trial
Show all 10Show fewer
- age,
- gender and
- education (duration of school attendance) matched
- and/or cervical dystonia
Who cannot join
- neurological or psychiatric comorbidity
- psychotropic drugs
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Neurology, Medical University of Vienna
Vienna, State of Vienna, 1090
About this study
Official title: 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.
Read more
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.
- Conditions
- Intelligence, Emotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
I-S-T-2000R- (intelligence-structure-test 2000R)
Test to evaluate Intelligence
- Subtest "Matrixes"
- Subtest "Analogies"
Measured: up to four weeks
Secondary outcomes (2)
Beck's depression-inventory-II
Evaluation of depression (BDI-II; Hautzinger et al., 2009)
Measured: up to four weeks
Apathy Evaluation Scale
Evaluation of apathy (AES; Luecken et al., 2006)
Measured: up to four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2014 (estimated)
- Study startAug 2012
- Primary completionMay 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for IntelligenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsten Elwischger, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kirsten Elwischger, MD, Medical University of Vienna
- Investigators
- Eduard Auff, Prof., MD, Principal investigator, Department of Neurology, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179450
- Sponsor's protocol ID
- Cognition_Facial palsy
- Status last verified
- Jun 2014
- First submitted
- 31 Dec 2012
- Last updated
- 1 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20548056Alam 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.
PubMed 18485989Hennenlotter 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.
PubMed 18562330Platho-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.
PubMed 34496270
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Assessing Cognitive Function and Emotional Possessing in Patients With Bilateral Facial Palsy
- ClinicalTrials.gov ID
- NCT02179450
- Acronym / sponsor ID
- Cognition_Facial palsy
- Conditions
- Intelligence, Emotion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Kirsten Elwischger, MDUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 1 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (10 listed)
- willing to participate in this pilot trial
- bilateral facial palsy
- age 18-80 years
- willing to participate in this pilot trial
- age,
Key exclusion criteria (2 listed)
- neurological or psychiatric comorbidity
- psychotropic drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
I-S-T-2000R- (intelligence-structure-test 2000R)
Time frame: up to four weeks
Test to evaluate Intelligence * Subtest "Matrixes" * Subtest "Analogies"
2 secondary outcomes
Beck's depression-inventory-II
Time frame: up to four weeks
Apathy Evaluation Scale
Time frame: up to four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2014.
- Background: PubMed 20548056Havas 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.
- Background: PubMed 18485989Alam 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.
- Background: PubMed 18562330Hennenlotter 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.
- Derived from this study: PubMed 34496270Platho-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.
Related trials for Intelligence
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruitingObservational study
AI-assisted Tracheal Intubation in Children
Intubation
Recruiting
AI-assisted Home-based Intervention for ADHD Children
ADHD - Attention Deficit Disorder With Hyperactivity, ADHD - Combined Type
Not yet recruitingObservational study
Discovering Determinants of Food Intake by Application of Artificial Intelligence to Complex, High-Dimensional Data
Healthy Volunteer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduard Auff, Prof., MD principal investigator
Department of Neurology, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intelligence and Emotion, run by Kirsten Elwischger, MD at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
I-S-T-2000R- (intelligence-structure-test 2000R) (time frame: up to four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02179450, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2014.