- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01223144
Decision-making and Emotion Recognition in Essential Tremor (EMOTREM)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pessac, France, 33604
- CHU de Bordeaux, Hôpital du Haut-Lévêque
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients with essential tremor
|
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
|
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). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 day (duration of study)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 day (duration of study)
|
|
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). |
1 day (duration of study)
|
|
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)
|
1 day (duration of study)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wassilios Meissner, MD, PhD, University Hospital Bordeaux, France
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2010/10
- 2010-A00479-30 (Other Identifier: ANSM)
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