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Decision-making and Emotion Recognition in Essential Tremor (EMOTREM)

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ClinicalTrials.gov Identifier: NCT01223144
Recruitment Status : Completed
First Posted : October 18, 2010
Last Update Posted : June 8, 2012
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Study Description
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Brief Summary:
The present study aims at investigating cognitive functions requiring orbitofrontal control, namely decision-making and facial emotion recognition. The investigators hypothesize that decision-making and facial emotion recognition are impaired in patients with essential tremor (ET) due to frontal lobe dysfunction which may have consequences in daily social life.

Condition or disease Intervention/treatment Phase
Essential Tremor Behavioral: Iowa Gambling Task and Ekman facial recognition test Not Applicable

Detailed Description:

Beyond tremor, ET patients display a wide spectrum of clinical abnormalities such as ataxia, deafness, olfactory disturbances, cognitive dysfunction and personality changes. Cognitive dysfunction mainly consists in a dysexecutive syndrome. Personality changes are characterized by increased harm avoidance. These findings suggest a complex modification in frontal lobe function in ET patients, including aspects of dorsolateral and orbitofrontal control. Previous studies have exclusively focused on dorsolateral prefrontal control, while orbitofrontal aspects remain to be elucidated. Orbitofrontal areas are involved in processing emotion and reward, as well as normal social behavior. Dysfunction in these regions may have direct consequences in daily social life.

We hypothesize that decision-making and facial emotion recognition are impaired in ET patients due to frontal lobe dysfunction which may have consequences in daily social life. The first aspect can be assessed with the Iowa Gambling Task, a simple paradigm that simulates real-life decision-making. Briefly, players are given four decks of cards, a loan of $ 2,000 and asked to play so they can lose the least amount of money and win the most. Turning each card carries an immediate reward and sometimes an unpredictable penalty. Decks A and B are the most disadvantageous leading to an overall loss of money, while decks C and D are the most advantageous with an overall gain of money. In contrast to control subjects, patients with damage of the orbitofrontal or ventromedian cortex continue to perseverate with the bad decks, sometimes even though they know that they are losing money overall. The second aspect, i.e. the recognition of facial emotion can be assessed in a simple paradigm where patients have to choose the best fitting response among six facial expressions (happiness, sadness, fear, surprise, disgust and anger) that are presented in random order. All study subjects will be tested with the Benton Visual Retention Test to exclude impairment in visual perception, visual memory or visuoconstructive abilities.

Performances in the Iowa Gambling Task and the facial emotion recognition test will be compared between ET patients and controls. All study subjects will also be tested with the following battery: Modified Card Sorting Test, Stroop, Trail Making Test and Verbal Fluency, Beck Depression Inventory and the Mattis Dementia Rating Scale. These tests will allow assessing the impact of executive function, depression and memory loss on performances in the Iowa Gambling Task and the facial emotion recognition test. Finally, performances in the Iowa Gambling Task and the facial emotion recognition test will be related to sex, age, disease duration and tremor severity.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Decision-making and Emotion Recognition in Essential Tremor
Study Start Date : September 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Patients with essential tremor
Patients with essential tremor
 Behavioral: Iowa Gambling Task and Ekman facial recognition test

Iowa Gambling Task: mean number of cards chosen from decks with low (A+B) and high gain (C+D).

Ekman facial recognition test: mean number of faces correctly recognized (60 images with 6 different expressions: happiness, sadness, fear, surprise, disgust and anger).
Active Comparator: age- and sex-matched control subjects
age- and sex-matched control subjects
 Behavioral: Iowa Gambling Task and Ekman facial recognition test

Iowa Gambling Task: mean number of cards chosen from decks with low (A+B) and high gain (C+D).

Ekman facial recognition test: mean number of faces correctly recognized (60 images with 6 different expressions: happiness, sadness, fear, surprise, disgust and anger).


Outcome Measures
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Primary Outcome Measures :
  1. Comparison of the performance in the Iowa Gambling Task and the Ekman facial recognition test [ Time Frame: 1 day (duration of study) ]

    Comparison of the performance in the Iowa Gambling Task and the Ekman facial recognition test between patients and age- and sex-matched controls.

    • Iowa Gambling Task: mean number of cards chosen from decks with low (A+B) and high gain (C+D).
    • Ekman facial recognition test: mean number of faces correctly recognized (60 images with 6 different expressions: happiness, sadness, fear, surprise, disgust and anger).


Secondary Outcome Measures :
  1. Risk anticipation as assessed by the number of advantageous minus disadvantageous choices in the Iowa Gambling Task. [ Time Frame: 1 day (duration of study) ]
    Risk anticipation as assessed by the number of advantageous minus disadvantageous choices in the Iowa Gambling Task.

  2. Assessment of the relation between the primary outcome measures and age, sex, disease duration, as well as tremor severity. [ Time Frame: 1 day (duration of study) ]

    Assessment of the relation between the primary outcome measures and age, sex, disease duration, as well as tremor severity.

    Tremor severity is evaluated by the revised WHIGET tremor rating scale (severity score 0-36 points).


  3. Assessment of the relation between the primary outcome measures and executive function and depression. [ Time Frame: 1 day (duration of study) ]
    Executive function Number of categories in the Modified Card Sorting Test Time in seconds and number of errors in the Trail Making Test Time in seconds and number of errors in the Stroop Test Verbal Fluency score Mattis Dementia Rating scale score (0-144 points) Depression is evaluated by the Beck Depression Inventory (0-63 points)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient:

    • Age over 18 years
    • Patient diagnosed as having essential tremor
    • Written informed consent
    • Patient covered by the French health insurance system

  • Control:

    • Age over 18 years
    • No diagnosis of essential tremor
    • Written informed consent
    • Subject covered by the French health insurance system

Exclusion Criteria:

  • Patient:

    • Dementia (MMSE<24) or other known illness which could impact motor and cognitive performances
    • Patient unable to give written informed consent

  • Control:

    • Same exclusion criteria as for patients
Contacts and Locations
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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): NCT01223144


Locations
France
CHU de Bordeaux, Hôpital du Haut-Lévêque
Pessac, France, 33604
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Wassilios Meissner, MD, PhD University Hospital Bordeaux, France
More Information
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01223144     History of Changes
Other Study ID Numbers: CHUBX 2010/10
First Posted: October 18, 2010    Key Record Dates
Last Update Posted: June 8, 2012
Last Verified: June 2012

Keywords provided by University Hospital, Bordeaux:
Cognition
orbitofrontal cortex
Iowa Gambling Task
facial emotion recognition

Additional relevant MeSH terms:
Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
 Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases