NCT01633905

Brief Summary

Alcohol-dependence is the most widespread addiction in Western countries and leads to a wide range of impairments at cerebral and cognitive levels. It has also been showed that alcohol-dependence is associated with emotional disturbances, particularly for the decoding of emotional facial expressions (EFE). In view of the crucial role played by EFE to develop and maintain satisfactory interpersonal relations, this emotional processing impairment may have deleterious consequences on alcohol-dependent patient's social well-being, and this deficit is thus of particular clinical interest. Nevertheless, this deficit has up to now been evaluated only by means of experiments using paradigms with low ecological value (i.e. presentation of EFE in isolation and in the central vision field), while in the real life, emotional stimuli are most frequently appearing together with other emotional stimulations (particularly voices) and in the peripheral vision field. Moreover, the cerebral correlates of this emotional deficit are still to be determined. The present study thus aims at exploring the Emotional Facial Expressions (EFE) decoding in alcoholism using a more ecological paradigm, based on peripheral presentation of emotional crossmodal stimuli (i.e. the simultaneous presentation of emotionally congruent face and voice). Main aim: Determining the electrophysiological characteristics (latencies and amplitudes) of the event-related components elicited among recently detoxified alcohol-dependent participants, while performing an emotion-detection task on crossmodal stimuli (voices and/or faces) presented centrally or peripherally, and comparing these characteristics with those obtained among paired healthy participants. Secondary objectives:

  • Exploring the electrophysiological pattern modifications among alcohol-dependent participants for the emotional faces and voices decoding (unimodal conditions), using spatio-temporal analyses methods.
  • Exploring the electrophysiological waves associated with peripheral crossmodal stimuli processing among healthy participants.
  • Exploring the behavioral correlates (reaction times and accuracy) of the emotion-detection task among alcohol-dependent participants while processing peripheral stimuli.
  • Exploring the psychopathological comorbidities among alcohol-dependent participants and their influence on the behavioral and electrophysiological results.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2010

Longer than P75 for all trials

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

December 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2011

Completed
11 months until next milestone

First Posted

Study publicly available on registry

July 4, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

June 17, 2015

Status Verified

June 1, 2015

Enrollment Period

4 years

First QC Date

August 9, 2011

Last Update Submit

June 16, 2015

Conditions

Keywords

alcohol-dependenceevent-related potentialsemotioncrossmodalperipheral processing

Outcome Measures

Primary Outcomes (1)

  • brain electrical responses amplitudes and latencies

    Differences in latencies, mainly the P3b wave, in milliseconds and differences in brain electrical responses amplitudes in millivolts, between the alcohol-dependent group and the healthy participants group.

    participants will be followed an average of 2 hours for the duration of experiment

Secondary Outcomes (3)

  • reactions times

    participants will be followed an average of 2 hours for the duration of experiment

  • behavioural and psychopathological measures

    participants will be followed an average of 2 hours for the duration of experiment

  • percentage of correct answers

    participants will be followed an average of 2 hours for the duration of experiment

Study Arms (2)

alcohol-dependent patients

22 recently detoxified participants diagnosed as alcohol-dependant on the basis of DSM-IV criteria who will performed an emotion-detection task on unimodal (visual or auditory) or crossmodal (visuo-auditory) stimulations presented centrally or peripherally

control group

22 healthy controls without any psychiatric or neurological diagnosis who will performed an emotion-detection task on unimodal (visual or auditory) or crossmodal (visuo-auditory) stimulations presented centrally or peripherally

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

* 22 recently detoxified participants, diagnosed as alcohol-dependent on the basis of DSM-IV criteria, free of any alcohol consumption during the last 15 days, and without any other DSM-IV criteria * 22 healthy controls paired for gender, age and educational level with alcohol-dependent participants, without any alcohol consumption during the last three days and without any psychiatric or neurological diagnosis. All participants will be between 18 and 60 years of age, will be French-speaking and will present a normal or corrected-to-normal auditory and visual acuity.

You may qualify if:

  • for alcohol-dependence group : alcohol-dependent subjects
  • for control group : healthy volunteers without psychiatric
  • for control group : healthy volunteers without neurological diagnosis

You may not qualify if:

  • more than 60 years old and less than 18 years old,
  • no French-speaking,
  • not normal or not corrected-to-normal auditory acuity,
  • not normal or not corrected-to-normal visual acuity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Lille

Lille, 59037, France

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Olivier COTTENCIN

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2011

First Posted

July 4, 2012

Study Start

December 1, 2010

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

June 17, 2015

Record last verified: 2015-06

Locations