NCT01223144

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 15, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 18, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

June 8, 2012

Status Verified

June 1, 2012

Enrollment Period

1.2 years

First QC Date

October 15, 2010

Last Update Submit

June 7, 2012

Conditions

Keywords

Cognitionorbitofrontal cortexIowa Gambling Taskfacial emotion recognition

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

EXPERIMENTAL

Patients with essential tremor

Behavioral: Iowa Gambling Task and Ekman facial recognition test

age- and sex-matched control subjects

ACTIVE COMPARATOR

age- and sex-matched control subjects

Behavioral: Iowa Gambling Task and Ekman facial recognition test

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).

Patients with essential tremorage- and sex-matched control subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Wassilios Meissner, MD, PhD

    University Hospital Bordeaux, France

    PRINCIPAL INVESTIGATOR

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

Locations