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

Primary Purpose

Essential Tremor

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Iowa Gambling Task and Ekman facial recognition test
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Essential Tremor focused on measuring Cognition, orbitofrontal cortex, Iowa Gambling Task, facial emotion recognition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU de Bordeaux, Hôpital du Haut-Lévêque

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patients with essential tremor

age- and sex-matched control subjects

Arm Description

Patients with essential tremor

age- and sex-matched control subjects

Outcomes

Primary Outcome Measures

Comparison of the performance in the Iowa Gambling Task and the Ekman facial recognition test
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

Risk anticipation as assessed by the number of advantageous minus disadvantageous choices in the Iowa Gambling Task.
Risk anticipation as assessed by the number of advantageous minus disadvantageous choices in the Iowa Gambling Task.
Assessment of the relation between the primary outcome measures and age, sex, disease duration, as well as tremor severity.
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).
Assessment of the relation between the primary outcome measures and executive function and depression.
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)

Full Information

First Posted
October 15, 2010
Last Updated
June 7, 2012
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT01223144
Brief Title
Decision-making and Emotion Recognition in Essential Tremor
Acronym
EMOTREM
Official Title
Decision-making and Emotion Recognition in Essential Tremor
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor
Keywords
Cognition, orbitofrontal cortex, Iowa Gambling Task, facial emotion recognition

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with essential tremor
Arm Type
Experimental
Arm Description
Patients with essential tremor
Arm Title
age- and sex-matched control subjects
Arm Type
Active Comparator
Arm Description
age- and sex-matched control subjects
Intervention Type
Behavioral
Intervention Name(s)
Iowa Gambling Task and Ekman facial recognition test
Intervention Description
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).
Primary Outcome Measure Information:
Title
Comparison of the performance in the Iowa Gambling Task and the Ekman facial recognition test
Description
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).
Time Frame
1 day (duration of study)
Secondary Outcome Measure Information:
Title
Risk anticipation as assessed by the number of advantageous minus disadvantageous choices in the Iowa Gambling Task.
Description
Risk anticipation as assessed by the number of advantageous minus disadvantageous choices in the Iowa Gambling Task.
Time Frame
1 day (duration of study)
Title
Assessment of the relation between the primary outcome measures and age, sex, disease duration, as well as tremor severity.
Description
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).
Time Frame
1 day (duration of study)
Title
Assessment of the relation between the primary outcome measures and executive function and depression.
Description
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)
Time Frame
1 day (duration of study)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wassilios Meissner, MD, PhD
Organizational Affiliation
University Hospital Bordeaux, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Bordeaux, Hôpital du Haut-Lévêque
City
Pessac
ZIP/Postal Code
33604
Country
France

12. IPD Sharing Statement

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Decision-making and Emotion Recognition in Essential Tremor

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