Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-03-04 @ 7:50 PM
Study NCT ID:
NCT03793920
Status:
UNKNOWN
Last Update Posted:
2022-10-03
First Post:
2018-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Prenatal Alcohol Exposure on Emotional and Cognitive Abilities in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016739', 'term': 'Behavior, Addictive'}, {'id': 'D063647', 'term': 'Fetal Alcohol Spectrum Disorders'}], 'ancestors': [{'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D005315', 'term': 'Fetal Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D020751', 'term': 'Alcohol-Induced Disorders'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-11-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-30', 'studyFirstSubmitDate': '2018-12-18', 'studyFirstSubmitQcDate': '2019-01-03', 'lastUpdatePostDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of correct answers of an emotional facial expression (EFE)', 'timeFrame': 'one day', 'description': 'Performance of an emotional facial expression (EFE) decoding task in EPA subjects and compare it to non-alcohol dependent controls'}], 'secondaryOutcomes': [{'measure': 'Psychopathological assessment by Mini International Neuropsychiatric Interview MINI', 'timeFrame': 'one day', 'description': 'Presence of psychiatric disorders by a standardized psychiatric interview'}, {'measure': 'Percentage of correct answers ant latency of behavioral answers', 'timeFrame': 'one day', 'description': 'Performance of behavioral tasks'}, {'measure': 'State-Trait-Anxiety Inventory (STAI) score', 'timeFrame': 'one day', 'description': 'Score at STAI STAI is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis'}, {'measure': 'Beck Depression Inventory score', 'timeFrame': 'one day', 'description': "Score at Beck Depression Inventory The BDI consisted of twenty-one questions about how the subject has been feeling in the last week. Each question had a set of at least four possible responses, ranging in intensity. (0) I do not feel sad/ (1) I feel sad./ (2) I am sad all the time and I can't snap out of it/ (3) I am so sad or unhappy that I can't stand it.\n\nWhen the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-off scores were as follows:0-9: indicates minimal depression/ 10-18: indicates mild depression/ 19-29: indicates moderate depression/ 30-63: indicates severe depression."}, {'measure': 'Toronto Alexithymia Scale TAS-20 score', 'timeFrame': 'one day', 'description': 'Score at TAS-20 The Toronto Alexithymia Scale is a measure of deficiency in understanding, processing, or describing emotions. The current version has twenty statements rated on a five-point Likert scale. ( range : Strongly disagree/Disagree/ Neither agree nor disagree/ Agree/ Strongly agree)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prenatal alcohol exposure', 'Emotional', 'Cognition', 'Addiction', 'Fetal Alcohol Syndrome'], 'conditions': ['Prenatal Alcohol Exposure']}, 'descriptionModule': {'briefSummary': 'Hypothesis:\n\nIndividuals presenting with prenatal alcohol exposure (PEA) show emotional abilities deficits, and imbalance between the two systems involved in decision-making according to dual-process models, namely an under-activated reflective system (involved in deliberate behaviors) and an over-activated affective-automatic one (involved in impulsive behaviors).\n\nPrimary objective:\n\nTo explore performance (as a percentage of correct answers) in an emotional facial expression decoding task in PEA participants compared to controls without alcohol disorder.', 'detailedDescription': 'Each participant will undergo 2 visits :\n\nFirst visit :\n\n* Checking inclusion and non-inclusion criteria\n* Note of information and consent form\n* Record of concomitant treatments and anamnestic elements\n* Alcohol, Tobacco, and Toxic Consumption\n* Urinary Toxicity Test for Control Groups\n* Laterality test (Hecaen, 1984)\n* Brief visual and auditory acuity test\n* Standardized psychiatric interview (Mini International Neuropsychiatric Interview - MINI)\n\nSecond visit = Experimental testing\n\n* State-Trait Anxiety Inventory, Beck Depression Inventory, Inventory of Interpersonal Problems, Toronto Alexithymia Scale (TAS-20).\n* Participant installation and testing: 6 behavioral tasks on a computer (also used to collect responses, except for task 2, see details below) :\n\nTask 1 (MAIN): Test for recognition of facial emotions Task 2: \'Reading the Mind in the Eyes Test\' (Decoding of complex emotional states) Task 3: Emotional evaluation of natural scenes Task 4: Target detection (measure of attentional bias towards alcohol-related stimuli) Task 5: Go / No-Go evaluating the interactions between inhibition processes and auto-affective system Task 6: "N-back" evaluating the interactions between working memory and automatic-affective system'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Man or woman aged between 18 and 60 years\n* Able to understand and to speak French\n* Able to understand Note of information and to sign consent form\n* Available health insurance\n* Normal (or corrected to normal) vision and audition\n* For women: Negative pregnancy test or menopausal for at least one year\n* For Group 1 only : PEA criteria and no alcohol consumption within the three days preceding the experiment.\n* For Group 2 only : PEA criteria, diagnosed with severe alcohol addiction and currently abstinent (for at least 15 days).\n* For Group 3 only : Non-alcohol-dependent controls. No alcohol consumption within the three days preceding the experiment and father diagnosed with severe alcohol addiction.\n* For Group 4 only : Non-alcohol-dependent controls. No alcohol consumption within the three days preceding the experiment.\n\nExclusion Criteria:\n\n* Refusal of participation after clear and fair information on the study.\n* Visual or auditory sensory disability to participate in the study.\n* Benzodiazepines and / or Antipsychotic concomitant treatment.\n* History of (or current) neurologic disease\n* History of (or current) psychiatric disorder (apart alcohol-dependence for the PEA-alcohol-dependent group)\n* Psychoactive Substance Use or Abuse other than tobacco and alcohol.\n* Pregnant or breast-feeding women.\n* Underage (\\<18 yo) or adults under guardianship, judicial protection, or deprived of liberty.'}, 'identificationModule': {'nctId': 'NCT03793920', 'acronym': 'ALTEMO', 'briefTitle': 'Effects of Prenatal Alcohol Exposure on Emotional and Cognitive Abilities in Adults', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Behavioral Exploration of Cognitive and Emotional Alterations in Adult Individuals Exposed to Alcohol During the Prenatal Period', 'orgStudyIdInfo': {'id': '2015_76'}, 'secondaryIdInfos': [{'id': '2017-A00843-50', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PEA patients without alcohol disorder', 'description': 'A group of 36 PEA patient without alcohol-dependence (AD), performing 6 behavioral tasks.', 'interventionNames': ['Other: Facial Emotion Test']}, {'type': 'SHAM_COMPARATOR', 'label': 'PEA patients with alcohol disorder', 'description': 'A group of 36 PEA participants, currently alcohol-dependent, performing 6 behavioral tasks.', 'interventionNames': ['Other: Facial Emotion Test']}, {'type': 'SHAM_COMPARATOR', 'label': 'Healthy controls with AD father', 'description': 'A group of 36 non-alcohol-dependent controls whose father was alcohol-dependent during their childhood and adolescence, performing 6 behavioral tasks.', 'interventionNames': ['Other: Facial Emotion Test']}, {'type': 'SHAM_COMPARATOR', 'label': 'Healthy controls without AD father', 'description': 'A group of 36 non-alcohol-dependent controls whose father was not alcohol-dependent during their childhood and adolescence, performing 6 behavioral tasks.', 'interventionNames': ['Other: Facial Emotion Test']}], 'interventions': [{'name': 'Facial Emotion Test', 'type': 'OTHER', 'description': 'All tasks will be delivered using a laptop and E-Prime 2 software (Psychology Software Tools, Inc., Pittsburgh), which will also be used to collect behavioral responses.', 'armGroupLabels': ['Healthy controls with AD father', 'Healthy controls without AD father', 'PEA patients with alcohol disorder', 'PEA patients without alcohol disorder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'CSAPA', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lille', 'country': 'France', 'facility': 'CHRU Lille, Fontan2', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Olivier COTTENCIN, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}