Decision-making and Emotion Recognition in Essential Tremor
EMOTREM
1 other identifier
interventional
39
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 15, 2010
CompletedFirst Posted
Study publicly available on registry
October 18, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJune 8, 2012
June 1, 2012
1.2 years
October 15, 2010
June 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (3)
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.
1 day (duration of study)
Assessment of the relation between the primary outcome measures and executive function and depression.
1 day (duration of study)
Study Arms (2)
Patients with essential tremor
EXPERIMENTALPatients with essential tremor
age- and sex-matched control subjects
ACTIVE COMPARATORage- and sex-matched control subjects
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patient:
- Dementia (MMSE\<24) or other known illness which could impact motor and cognitive performances
- Patient unable to give written informed consent
- Control:
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Bordeaux, Hôpital du Haut-Lévêque
Pessac, 33604, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wassilios Meissner, MD, PhD
University Hospital Bordeaux, France
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2010
First Posted
October 18, 2010
Study Start
September 1, 2010
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
June 8, 2012
Record last verified: 2012-06