Alcohol-dependenceALCOLATNCT01633905
Electrophysiological Correlates of Emotional and Crossmodal Stimuli Processing Among Alcohol-dependent Participants
An observational study of Alcohol-dependence, run by University Hospital, Lille at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol-dependence
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2010to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- for alcohol-dependence group : alcohol-dependent subjects
- for control group : healthy volunteers without psychiatric
- for control group : healthy volunteers without neurological diagnosis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electrophysiological Correlates of Emotional and Crossmodal Stimuli Processing Among Alcohol-dependent Participants : Exploration of the Peripheral Presentation Effect
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).
Read more
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.
Read the detailed description
Methodology: Evaluation the event-related potentials elicited among alcohol-dependent and healthy participants while performing an emotion-detection task on unimodal (visual or auditory) or crossmodal (visuo-auditory) stimulations presented centrally or peripherally. Event-related potentials allow to monitor the electrical activity of the brain with high temporal resolution and to detect even minor neurocognitive restrictions. This cerebral measures will be completed by behavioral (reaction times and accuracy) and psychopathological measures.
No specific interventions assigned to the subjects of the study.
Evaluations: The room contains a panoramic screen (2.4 X 4 meters) covering a 180 degrees of visual angle. Participants will seat in a chair situated two meters away from the screen, in front of a table on which the response pad will be placed. Three projectors will display the visual stimulations, either centrally or lateralized (-12°, -24°on the left or +12°, +24° on the right). Headphones will be placed on participants' ears in order to display the auditory stimulations, either on both ears or lateralized (left or right ear), and presented separately (unimodal conditions) or simultaneously (crossmodal condition) with the visual stimuli. Visual stimuli, constructed using FaceGen 3.4 program, will be emotional faces (two males, two females) depicting happiness, anger or a neutral expression. Auditory stimuli (two males, two females), from a validated battery, will be emotional voices depicting happiness, anger or a neutral prosody and presented at a 70 decibels level. Crossmodal stimulations will be a combination of visual and auditory stimuli, congruent for gender and emotion. Experiment will be composed of 39 conditions: 3 stimulations (visual, auditory, visuo-auditory) X 3 emotions (anger, happiness, neutral) X 3/5 lateralisation (-24°, -12°, 0°, 12°, 24°). Each condition will be evaluated on the basis of 50 stimulations. Event-related potentials will be recorded during the whole experiment by means of a 128 electrodes cap placed on participant's head and connected with an amplifier (Advanced Neuro Technology, ANT) and a recording computer, synchronised with the stimulation system. Behavioral responses will be recorded by means of a response pad. Psychopathological measures will be conducted using validated questionnaires: State and trait anxiety (STAI A and B, Spielberger et al., 1983), depression (BDI, Beck et al., 1987), interpersonal problems (Horowitz et al. (1988)), evaluating the quantity and quality of the social interactions, and the integration in the family and relationship background and alexithymia (Bagby et al., 1994).
- Conditions
- Alcohol-dependence
- Keywords
- alcohol-dependence, event-related potentials, emotion, crossmodal, peripheral processing
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: participants will be followed an average of 2 hours for the duration of experiment
Secondary outcomes (3)
reactions times
Differences in reactions times during the emotion-detection task between the two groups.
Measured: participants will be followed an average of 2 hours for the duration of experiment
behavioural and psychopathological measures
Differences in anxiety level, psychopathology, interpersonal problems level, alexithymia level, measured by validated questionnaires.
Measured: participants will be followed an average of 2 hours for the duration of experiment
percentage of correct answers
Differences in percentage of correct answers between the two groups.
Measured: participants will be followed an average of 2 hours for the duration of experiment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startDec 2010
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol-dependenceStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier COTTENCIN, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633905
- Sponsor's protocol ID
- 2010_01
- Other IDs
- 2010-A00595-34
- Acronym
- ALCOLAT
- Status last verified
- Jun 2015
- First submitted
- 9 Aug 2011
- Last updated
- 17 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiological Correlates of Emotional and Crossmodal Stimuli Processing Among Alcohol-dependent Participants : Exploration of the Peripheral Presentation Effect
- ClinicalTrials.gov ID
- NCT01633905
- Acronym / sponsor ID
- ALCOLAT / 2010_01
- Conditions
- Alcohol-dependence
- Keywords
- alcohol-dependence, event-related potentials, emotion, crossmodal, peripheral processing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Methodology: Evaluation the event-related potentials elicited among alcohol-dependent and healthy participants while performing an emotion-detection task on unimodal (visual or auditory) or crossmodal (visuo-auditory) stimulations presented centrally or peripherally. Event-related potentials allow to monitor the electrical activity of the brain with high temporal resolution and to detect even minor neurocognitive restrictions. This cerebral measures will be completed by behavioral (reaction times and accuracy) and psychopathological measures.
No specific interventions assigned to the subjects of the study.
Evaluations: The room contains a panoramic screen (2.4 X 4 meters) covering a 180 degrees of visual angle. Participants will seat in a chair situated two meters away from the screen, in front of a table on which the response pad will be placed. Three projectors will display the visual stimulations, either centrally or lateralized (-12°, -24°on the left or +12°, +24° on the right). Headphones will be placed on participants' ears in order to display the auditory stimulations, either on both ears or lateralized (left or right ear), and presented separately (unimodal conditions) or simultaneously (crossmodal condition) with the visual stimuli. Visual stimuli, constructed using FaceGen 3.4 program, will be emotional faces (two males, two females) depicting happiness, anger or a neutral expression. Auditory stimuli (two males, two females), from a validated battery, will be emotional voices depicting happiness, anger or a neutral prosody and presented at a 70 decibels level. Crossmodal stimulations will be a combination of visual and auditory stimuli, congruent for gender and emotion. Experiment will be composed of 39 conditions: 3 stimulations (visual, auditory, visuo-auditory) X 3 emotions (anger, happiness, neutral) X 3/5 lateralisation (-24°, -12°, 0°, 12°, 24°). Each condition will be evaluated on the basis of 50 stimulations. Event-related potentials will be recorded during the whole experiment by means of a 128 electrodes cap placed on participant's head and connected with an amplifier (Advanced Neuro Technology, ANT) and a recording computer, synchronised with the stimulation system. Behavioral responses will be recorded by means of a response pad. Psychopathological measures will be conducted using validated questionnaires: State and trait anxiety (STAI A and B, Spielberger et al., 1983), depression (BDI, Beck et al., 1987), interpersonal problems (Horowitz et al. (1988)), evaluating the quantity and quality of the social interactions, and the integration in the family and relationship background and alexithymia (Bagby et al., 1994).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- for alcohol-dependence group : alcohol-dependent subjects
- for control group : healthy volunteers without psychiatric
- for control group : healthy volunteers without neurological diagnosis
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
brain electrical responses amplitudes and latencies
Time frame: participants will be followed an average of 2 hours for the duration of experiment
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.
3 secondary outcomes
reactions times
Time frame: participants will be followed an average of 2 hours for the duration of experiment
behavioural and psychopathological measures
Time frame: participants will be followed an average of 2 hours for the duration of experiment
percentage of correct answers
Time frame: participants will be followed an average of 2 hours for the duration of experiment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier COTTENCIN principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol-dependence, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
brain electrical responses amplitudes and latencies (time frame: participants will be followed an average of 2 hours for the duration of experiment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2015.