Decision-making and Emotion Recognition in Essential Tremor

Essential Tremor Clinical Trial

— EMOTREM  

Official title:

Decision-making and Emotion Recognition in Essential Tremor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01223144
• Other study ID #: CHUBX 2010/10
• Status: Completed
• Phase: N/A
• First received: October 15, 2010
• Last updated: June 7, 2012
• Start date: September 2010
• Est. completion date: December 2011

Study information

• Verified date: June 2012
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Essential Tremor
• Tremor

Intervention

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).

Locations

Country	Name	City	State
France	CHU de Bordeaux, Hôpital du Haut-Lévêque	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1 day (duration of study)	No
Secondary	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.	1 day (duration of study)	No
Secondary	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).	1 day (duration of study)	No
Secondary	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)	1 day (duration of study)	No