Alcohol Use DisorderCOSEFEX-TNCT04647422
Social Cognition and Executive Functions in Alcohol Use Disorders - Transverse Study
A study testing Analysis of executive functioning and of social cognition processes in people with Alcohol Use Disorder, run by CHU de Reims at 1 site in France.
Trial summary
Over the past few years, researchers and clinicians have stressed the major role of executive and social cognition impairments in the development and the maintenance of Alcohol Use Disorders (AUD). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Analysis of executive functioning and of social cognition processes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteFrance
- Study dates
- 9 Dec 2020to 5 Dec 2024
- Phase
- Interventional
- 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
Who may be able to join
- Patients between 18 and 60 years old, men or women, following AUD treatment
- Having a diagnosis of alcohol use disorder according to DSM-5 criteria
- Patients withdrawn of alcohol for at least 15 days
- Patients being a native French speaker
- Patients enrolled in the national healthcare insurance program
- Patients consenting to participate to the study
Show all 17Show fewer
- Participants between 18 and 60 years old, men or women
- Current and past absence of any alcohol use disorder or any other substance use disorder as defined by DSM-5 diagnostic criteria
- Participants having at least one first-degree relative presenting an alcohol use disorder (father or sibling)
- Participants being a native French speaker
- Participants enrolled in the national healthcare insurance program
- Participants consenting to participate to the study
- Participants between 18 and 60 years old, men or women
- Current and past absence of any alcohol use disorder or any other substance use disorder as defined by DSM-5 diagnostic criteria
- Participants being a native French speaker
- Participants enrolled in the national healthcare insurance program
- Participants consenting to participate to the study
Who cannot join
- A diagnosis of schizophrenia, of any other chronic psychotic state, or of bipolar disorder according to DSM-5 criteria
- The presence of a current depressive episode as defined by DSM-5 criteria
- The presence of another substance use disorder during the six months preceding the study, except for tobacco dependence.
- The presence of any intellectual disability, of pervasive developmental disorders or learning difficulties (especially of dysphasia and dyspraxia)
- The presence of any neurological disorder or any other disorder affecting the central nervous system including Korsakoff syndrome or Wernicke's encephalopathy
- Having any uncorrected auditory or visual deficits
Show all 22Show fewer
- First-degree relatives of AUD patients
- The presence of any alcohol use disorder or any other substance use disorder as defined by DSM-5 diagnostic criteria, except for tobacco dependence
- A diagnosis of schizophrenia, of any other chronic psychotic state, or of bipolar disorder according to DSM-5 criteria
- The presence of a current depressive episode as defined by DSM-5 criteria
- The presence of any alcohol use disorder in the participant's biological mother in order to exclude fetal alcohol spectrum disorders due to prenatal alcohol intoxication
- The presence of any intellectual disability, of pervasive developmental disorders or learning difficulties (especially of dysphasia and dyspraxia)
- The presence of any neurological disorder or any other disorder affecting the central nervous system
- Participants having any uncorrected auditory or visual deficits
- Healthy control participants (the inclusion and non-inclusion criteria of investigation groups 2 and 4 are identical):
- The presence of any alcohol use disorder or any other substance use disorder as defined by DSM-5 diagnostic criteria, except for tobacco dependence
- A diagnosis of schizophrenia, of any other chronic psychotic state, or of bipolar disorder according to DSM-5 criteria
- The presence of a current depressive episode as defined by DSM-5 criteria
- Having any first-degree relative with alcohol use disorder (parents, siblings, children) according to DSM-5 diagnostic criteria
- The presence of any intellectual disability, of pervasive developmental disorders or learning difficulties (especially of dysphasia and dyspraxia)
- The presence of any neurological disorder or any other disorder affecting the central nervous system
- Participants having any uncorrected auditory or visual deficits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Social Cognition and Executive Functions as Cognitive Vulnerability Markers for the Development and Maintenance of Alcohol Use Disorders - a Transverse Study Design
Over the past few years, researchers and clinicians have stressed the major role of executive and social cognition impairments in the development and the maintenance of Alcohol Use Disorders (AUD).
Executive functions are defined as functions for behavioral control that help us to adjust the investigator's behavior in a flexible way in non-familiar, non-routine situations. Executive functions encompass different cognitive processes, such as inhibition, mental flexibility, updating, planification, abstraction, rule deduction or organization. Studies comparing AUD patients to healthy controls have shown that AUD usually is associated with a large range of deficits. More recently studies have also emphasized a weakness of executive functioning among healthy participants with a positive family history of AUD.
Read more
Social cognition refers to all cognitive processes that enable us to communicate and to interact with social environment in an appropriate manner. Among the most common social cognition sub-components are theory of mind (defined as the capacity to understand other people's mental states as for instance beliefs and desires), empathy, and emotion recognition. Emotional and interpersonal difficulties have a high prevalence in AUD and chronic alcohol consumption is often linked to social conflicts, misunderstandings, a lack of social support and isolation. Indeed, AUD patients have difficulties in understanding their own mental states and emotions as well as those of their social environment.
Few studies have investigated the interdependency between these cognitive impairments in AUD while a better understanding of the link between executive functions and social cognition seems crucial in order to better characterize the nature of AUD patients' deficits and thus their caring.
Read the detailed description
The aim of the study is to describe cognitive processes (theory of mind, empathy, and emotion recognition) and executive functions (inhibition, mental flexibility) in patients with AUD and first degree relatives of patients with an AUD.
- Conditions
- Alcohol Use Disorder
- Being tested
- Analysis of executive functioning and of social cognition processes
- Keywords
- Alcohol use disorder, high-risk individuals, executive functions, social cognition, endophenotypes, neuropsychology
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of executive functioning and of social cognition processesBehavioural
Investigation of executive and social cognition processes using a comprehensive, neuropsychological assessment, An Eye tracking investigation and Task-based MRI exams.
- Evaluation of addictive, psychiatric and neurological comorbidities.
- Neuropsychological assessment establishing the participants' cognitive profiles of executive functions and of social cognition
- An Eye tracking investigation aiming at a better understanding of participants' emotional processing
- Task-based MRI exams identifying participants' neuroanatomical and neurofunctional correlates of executive functions and of social cognition processes
| Study group | Role | What they receive |
|---|---|---|
| AUD patients | Experimental | Alcohol Use Disorder patients Receives: Behavioral: Analysis of executive functioning and of social cognition processes |
| AUD controls | Experimental | Healthy control participants matched to group 1 Receives: Behavioral: Analysis of executive functioning and of social cognition processes |
| First-degree relatives | Experimental | Healthy first-degree relatives of AUD patients Receives: Behavioral: Analysis of executive functioning and of social cognition processes |
| First-degree controls | Experimental | Healthy control participants matched to group 3 Receives: Behavioral: Analysis of executive functioning and of social cognition processes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive functions: mental flexibility performances and processing speed
Evaluated through the Trail Making Test (TMT parts A and B). In part A the participant must connect as quick as possible all the numbers on a sheet of paper in ascending order (1-25). In part B the participant is asked to connect all the numbers in ascending order (1-13) and all the letters according to their alphabetical order (A-L) whilst alternating between numbers and letters and without lifting the pencil. For both parts is reported the time necessary for task completion in seconds.
(Reitan RM, Wolfson D (1985) The Halstead-Reitan Neuropsychological Test Battery. Neuropsychology Press, Tucson, AZ.)
Measured: Day 0
Executive functions: mental flexibility performances
Evaluated through the Plus-Minus test. In this test, the participant is presented with three lists of 30 two-digit numbers. At first, the participant is asked to add three to all the numbers of a first list (+3). He must then subtract three from all the numbers of a second list (-3) and finally he must alternate between addition and subtraction when presented with a third list (+3/-3). Are measured the completion times for the three lists and participant's error rate.
(Miyake A, Friedman NP, Emerson MJ, Witzki AH, Howerter A, Wager TD (2000) The unity and diversity of executive functions and their contributions to complex "Frontal Lobe" tasks: a latent variable analysis. Cognitive Psychology 41, 49-100.)
Measured: Day 0
Executive functions: prepotent response inhibition
Evaluated through the Stroop test. The participant is shown three different slides with 100 items for 45s each. On the first slide are written color words (Color-word congruent condition) that the participant must read as quickly as possible. On the second slide are shown color patches (Color congruent condition) that the participants must name as quickly as possible. Finally, in the third condition, the participant is shown color words written in different colors and must try to name the color of the ink of the word without reading it (Interference condition). Are collected the completion times for the tree slides as well as self-corrected and uncorrected errors.
(Golden C.J (1976) Identification of brain disorders by the Stroop color and word test. Journal of Clinical Psychology 32, 654-658)
Measured: Day 0
Executive functions: inhibition of an ongoing motor response
Evaluated through the Stop signal task. The participant is presented with a series of photographs showing human faces and is instructed to categorize the photographs according to gender (Go trials). From time to time a red circle appears around the face after a variable time interval and the participant must then withhold his response (Stop trials). Are measured the response time on Go trials, the number and type of errors and the Stop Signal Reaction Time (SSRT).
(Verbruggen F., \& Logan G.D. (2008) Response inhibition in the stop-signal paradigm. Trends in cognitive sciences 12, 418-424.)
Measured: Day 0
Social cognition: facial emotion recognition
Evaluated through a test of facial emotion recognition (TREF). The participant is shown 54 photographs depicting 6 different emotions of variable intensity (joy, anger, sadness, disgust, contempt, fear) for which he must choose the corresponding emotion label. Are measured participant's response times, the number of correct responses (score out of 54) and type of errors.
(Gaudelus, B., Virgile, J., Peyroux, E., b, Leleu, A., c, Baudouin J.Y., Franck N. (2015). Mesure du déficit de reconnaissance des émotions faciales dans la schizophrénie. Étude préliminaire du test de reconnaissance des émotions faciales (TREF). L'encéphale 41(3), 251-259.)
Measured: Day 0
Social cognition: cognitive and affective theory of mind
Evaluated through The Movie of Assessment for Social Cognition (MASC). The participant is shown a movie of approximately 15 minutes displaying people interacting with each other. From time to time, the movie is stopped, and the participant must answer different questions relating to the thoughts and feelings of the characters. Are measured the number of correct responses out of 45.
(Dziobek I, Fleck S, Kalbe E, Rogers K, Hassenstab J, Brand M, Kessler J, Woike JK, Wolf OT, Convit A.J (2006). Journal of Autism and Developmental Disorders 36(5), 623-36.)
Measured: Day 0
Secondary outcomes (5)
Duration of ocular fixations
The mean duration of fixations will be evaluated using eye tracking. The participant is shown photographs of primary emotions and during the presentation are recorded his eye movements.
Measured: Day 0
Number of ocular saccades
The number of saccades will be evaluated using eye tracking. The participant is shown photographs of primary emotions and during the presentation are recorded his eye movements.
Measured: Day 0
Localization of the first ocular fixation
The localization of the first fixation will be evaluated using eye tracking. The participant is shown photographs of primary emotions and during the presentation are recorded his eye movements.
Measured: Day 0
fMRI behavioral responses during a cognitive and affective theory of mind task
During the task will be recorded the participant's behavioral performance (number of correct responses).
Measured: Day 0
fMRI activations during a cognitive and affective theory of mind task
Brain regions significantly activated during the task will be recorded as shown by the variations in the BOLD signal (whole brain analysis).
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start9 Dec 2020
- Primary completion5 Dec 2024
- Study completion5 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647422
- Sponsor's protocol ID
- PO20089
- Acronym
- COSEFEX-T
- Status last verified
- Feb 2025
- First submitted
- 16 Sep 2020
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schmid F, Henry A, Benzerouk F, Barriere S, Gondrexon J, Kaladjian A, Gierski F. Patterns of executive functions and theory of mind in adults with a family history of alcohol use disorder: Combined group and single-case analyses. Alcohol Clin Exp Res (Hoboken). 2024 Feb;48(2):362-374. doi: 10.1111/acer.15238. Epub 2024 Jan 20.
PubMed 38243915
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Social Cognition and Executive Functions as Cognitive Vulnerability Markers for the Development and Maintenance of Alcohol Use Disorders - a Transverse Study Design
- ClinicalTrials.gov ID
- NCT04647422
- Acronym / sponsor ID
- COSEFEX-T / PO20089
- Conditions
- Alcohol Use Disorder
- Keywords
- Alcohol use disorder, high-risk individuals, executive functions, social cognition, endophenotypes, neuropsychology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 5 Dec 2024 (actual)
- First posted
- 30 Nov 2020 (actual)
- 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.
Over the past few years, researchers and clinicians have stressed the major role of executive and social cognition impairments in the development and the maintenance of Alcohol Use Disorders (AUD).
Executive functions are defined as functions for behavioral control that help us to adjust the investigator's behavior in a flexible way in non-familiar, non-routine situations. Executive functions encompass different cognitive processes, such as inhibition, mental flexibility, updating, planification, abstraction, rule deduction or organization. Studies comparing AUD patients to healthy controls have shown that AUD usually is associated with a large range of deficits. More recently studies have also emphasized a weakness of executive functioning among healthy participants with a positive family history of AUD.
Social cognition refers to all cognitive processes that enable us to communicate and to interact with social environment in an appropriate manner. Among the most common social cognition sub-components are theory of mind (defined as the capacity to understand other people's mental states as for instance beliefs and desires), empathy, and emotion recognition. Emotional and interpersonal difficulties have a high prevalence in AUD and chronic alcohol consumption is often linked to social conflicts, misunderstandings, a lack of social support and isolation. Indeed, AUD patients have difficulties in understanding their own mental states and emotions as well as those of their social environment.
Few studies have investigated the interdependency between these cognitive impairments in AUD while a better understanding of the link between executive functions and social cognition seems crucial in order to better characterize the nature of AUD patients' deficits and thus their caring.
Detailed description
The aim of the study is to describe cognitive processes (theory of mind, empathy, and emotion recognition) and executive functions (inhibition, mental flexibility) in patients with AUD and first degree relatives of patients with an AUD.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AUD patients | Experimental | Behavioral: Analysis of executive functioning and of social cognition processesAlcohol Use Disorder patients |
| AUD controls | Experimental | Behavioral: Analysis of executive functioning and of social cognition processesHealthy control participants matched to group 1 |
| First-degree relatives | Experimental | Behavioral: Analysis of executive functioning and of social cognition processesHealthy first-degree relatives of AUD patients |
| First-degree controls | Experimental | Behavioral: Analysis of executive functioning and of social cognition processesHealthy control participants matched to group 3 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Participants between 18 and 60 years old, men or women
- Current and past absence of any alcohol use disorder or any other substance use disorder as defined by DSM-5 diagnostic criteria
- Participants being a native French speaker
- Participants enrolled in the national healthcare insurance program
- Participants consenting to participate to the study
Key exclusion criteria (22 listed)
- First-degree relatives of AUD patients
- Healthy control participants (the inclusion and non-inclusion criteria of investigation groups 2 and 4 are identical):
- The presence of any alcohol use disorder or any other substance use disorder as defined by DSM-5 diagnostic criteria, except for tobacco dependence
- A diagnosis of schizophrenia, of any other chronic psychotic state, or of bipolar disorder according to DSM-5 criteria
- The presence of a current depressive episode as defined by DSM-5 criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analysis of executive functioning and of social cognition processesInvestigation of executive and social cognition processes using a comprehensive, neuropsychological assessment, An Eye tracking investigation and Task-based MRI exams. * Evaluation of addictive, psychiatric and neurological comorbidities. * Neuropsychological assessment establishing the participants' cognitive profiles of executive functions and of social cognition * An Eye tracking investigation aiming at a better understanding of participants' emotional processing * Task-based MRI exams identifying participants' neuroanatomical and neurofunctional correlates of executive functions and of social cognition processes | Behavioural | AUD controls, AUD patients, First-degree controls, First-degree relatives |
Primary outcome
Executive functions: mental flexibility performances and processing speed
Time frame: Day 0
Evaluated through the Trail Making Test (TMT parts A and B). In part A the participant must connect as quick as possible all the numbers on a sheet of paper in ascending order (1-25). In part B the participant is asked to connect all the numbers in ascending order (1-13) and all the letters according to their alphabetical order (A-L) whilst alternating between numbers and letters and without lifting the pencil. For both parts is reported the time necessary for task completion in seconds. (Reitan RM, Wolfson D (1985) The Halstead-Reitan Neuropsychological Test Battery. Neuropsychology Press, Tucson, AZ.)
Executive functions: mental flexibility performances
Time frame: Day 0
Evaluated through the Plus-Minus test. In this test, the participant is presented with three lists of 30 two-digit numbers. At first, the participant is asked to add three to all the numbers of a first list (+3). He must then subtract three from all the numbers of a second list (-3) and finally he must alternate between addition and subtraction when presented with a third list (+3/-3). Are measured the completion times for the three lists and participant's error rate. (Miyake A, Friedman NP, Emerson MJ, Witzki AH, Howerter A, Wager TD (2000) The unity and diversity of executive functions and their contributions to complex "Frontal Lobe" tasks: a latent variable analysis. Cognitive Psychology 41, 49-100.)
Executive functions: prepotent response inhibition
Time frame: Day 0
Evaluated through the Stroop test. The participant is shown three different slides with 100 items for 45s each. On the first slide are written color words (Color-word congruent condition) that the participant must read as quickly as possible. On the second slide are shown color patches (Color congruent condition) that the participants must name as quickly as possible. Finally, in the third condition, the participant is shown color words written in different colors and must try to name the color of the ink of the word without reading it (Interference condition). Are collected the completion times for the tree slides as well as self-corrected and uncorrected errors. (Golden C.J (1976) Identification of brain disorders by the Stroop color and word test. Journal of Clinical Psychology 32, 654-658)
Executive functions: inhibition of an ongoing motor response
Time frame: Day 0
Evaluated through the Stop signal task. The participant is presented with a series of photographs showing human faces and is instructed to categorize the photographs according to gender (Go trials). From time to time a red circle appears around the face after a variable time interval and the participant must then withhold his response (Stop trials). Are measured the response time on Go trials, the number and type of errors and the Stop Signal Reaction Time (SSRT). (Verbruggen F., \& Logan G.D. (2008) Response inhibition in the stop-signal paradigm. Trends in cognitive sciences 12, 418-424.)
Social cognition: facial emotion recognition
Time frame: Day 0
Evaluated through a test of facial emotion recognition (TREF). The participant is shown 54 photographs depicting 6 different emotions of variable intensity (joy, anger, sadness, disgust, contempt, fear) for which he must choose the corresponding emotion label. Are measured participant's response times, the number of correct responses (score out of 54) and type of errors. (Gaudelus, B., Virgile, J., Peyroux, E., b, Leleu, A., c, Baudouin J.Y., Franck N. (2015). Mesure du déficit de reconnaissance des émotions faciales dans la schizophrénie. Étude préliminaire du test de reconnaissance des émotions faciales (TREF). L'encéphale 41(3), 251-259.)
Social cognition: cognitive and affective theory of mind
Time frame: Day 0
Evaluated through The Movie of Assessment for Social Cognition (MASC). The participant is shown a movie of approximately 15 minutes displaying people interacting with each other. From time to time, the movie is stopped, and the participant must answer different questions relating to the thoughts and feelings of the characters. Are measured the number of correct responses out of 45. (Dziobek I, Fleck S, Kalbe E, Rogers K, Hassenstab J, Brand M, Kessler J, Woike JK, Wolf OT, Convit A.J (2006). Journal of Autism and Developmental Disorders 36(5), 623-36.)
5 secondary outcomes
Duration of ocular fixations
Time frame: Day 0
Number of ocular saccades
Time frame: Day 0
Localization of the first ocular fixation
Time frame: Day 0
fMRI behavioral responses during a cognitive and affective theory of mind task
Time frame: Day 0
fMRI activations during a cognitive and affective theory of mind task
Time frame: Day 0
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 21 Jan 2026.
- Results publication: PubMed 38243915Schmid F, Henry A, Benzerouk F, Barriere S, Gondrexon J, Kaladjian A, Gierski F. Patterns of executive functions and theory of mind in adults with a family history of alcohol use disorder: Combined group and single-case analyses. Alcohol Clin Exp Res (Hoboken). 2024 Feb;48(2):362-374. doi: 10.1111/acer.15238. Epub 2024 Jan 20.
Related trials for Alcohol Use Disorder
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Analysis of executive functioning and of social cognition processes in people with Alcohol Use Disorder, run by CHU de Reims 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 17 inclusion and 22 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 21 Jan 2026. 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?
Executive functions: mental flexibility performances and processing speed (time frame: Day 0). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04647422, which also lists 1 linked publication.
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 21 Jan 2026.