Ignite Creation Date:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2026-01-05 @ 3:49 PM
Study NCT ID:
NCT03249857
Status:
COMPLETED
Last Update Posted:
2020-01-09
First Post:
2017-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Sensorimotor Compatibility Effects in Bipolar Affective Disorder.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-07', 'studyFirstSubmitDate': '2017-08-10', 'studyFirstSubmitQcDate': '2017-08-10', 'lastUpdatePostDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'response time for avoidance and affordance task', 'timeFrame': 'Months 24', 'description': 'Comparison of response time for avoidance and affordance task between patients and healthy volunteers.'}], 'secondaryOutcomes': [{'measure': 'response time for affordance task', 'timeFrame': 'Months 24', 'description': 'Comparison of response time for affordance task between patients and healthy volunteers.'}, {'measure': 'correlations with age at onset of the disease, the number of thymic decompensations and the existence of psychotic symptoms', 'timeFrame': 'Months 24', 'description': 'These informations were collected of the medical file.'}, {'measure': 'response time and cognitive tests', 'timeFrame': 'Months 24', 'description': 'Correlation between response time and cognitive tests of patients and healthy volunteers.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bipolar affective disorders', 'Cognition', 'Emotion', 'Embodiment', 'Sensorimotor', 'Simulation'], 'conditions': ['Bipolar Affective Disorder']}, 'descriptionModule': {'briefSummary': 'Based in an embodied approach of cognition, several studies have highlighted a direct link between perception of an object or an emotion and the associated motor responses. This study investigated in patients suffering from bipolar affective disorders whether the perception of emotional words involves an automatic sensorimotor simulation of approach and avoidance behaviors, and whether the perception of an object involves an automatic sensorimotor simulation of object prehension (affordance). We hypothesize that, in this pathology, low level (sensorimotor) cognitive processes are preserved whereas high-level (attentional) are altered. 20 patients suffering from bipolar affective disorders and 20 healthy controls will be recruited. The main objective is the emergence of sensorimotor compatibility effects in approach-avoidance task with emotional stimuli (gain between compatible vs incompatible conditions).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nFor patients:\n\n* Affiliated or entitled to a social security\n* Aged between 18 and 55\n* Patients of both sexes suffering from bipolar disorders (DSM V criteria) whatever the subtype\n* Stabilized from a point of view clinical and therapeutic\n* Euthymic (score \\<7 at the Hamilton scale, and score \\<8 at Young's scale)\n* Must have given their informed consent before their participation in the study\n* Be right-handed (score\\> 14 on the laterality scale)\n\nFor control group:\n\n* Affiliated or entitled to a social security\n* Must have given their informed consent before their participation in the study\n* Be right-handed (score\\> 14 on the lateral scale)\n* Aged 18 to 55 matched by age (± 5 years), sex, and on the study level of patients (years of schooling after primary school ± 2 years)\n\nExclusion Criteria:\n\nFor patients:\n\n* Thymic acute decompensation\n* Hamilton scale \\> 8, Young's scale \\> 9\n* Montreal Cognitive Assessment (MOCA) \\<26\n* History neurological pathology with cerebral impairment or serious somatic disease\n* Disorders related to the use of a psychoactive substance, as defined by the DSM-V (abuse, dependence or withdrawal) within 6 months.\n* IQ \\< 70\n* History of head trauma\n\nFor control group:\n\n* History of head trauma\n* Neurological pathology with cerebral impairment or serious somatic disease\n* Psychotropic treatment\n* Disorders related to the use of a psychoactive substance, as defined by the DSM-V (abuse, dependence or withdrawal)\n* IQ \\< 70"}, 'identificationModule': {'nctId': 'NCT03249857', 'briefTitle': 'Study of Sensorimotor Compatibility Effects in Bipolar Affective Disorder.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Study of Sensorimotor Compatibility Effects in Bipolar Affective Disorder.', 'orgStudyIdInfo': {'id': '1708056'}, 'secondaryIdInfos': [{'id': '2017-A00917-46', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients', 'description': 'Patients suffering bipolar affective disorders and who will perform cognitive tasks + IQ + MINI + experimental task', 'interventionNames': ['Behavioral: cognitive tasks + IQ + MINI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'Healthy volunteers (Control group) who will perform cognitive tasks + experimental task', 'interventionNames': ['Behavioral: cognitive tasks']}], 'interventions': [{'name': 'cognitive tasks + IQ + MINI', 'type': 'BEHAVIORAL', 'description': "Patients will perform different tasks:\n\n* cognitive tasks : reaction time (Alert TEA, Zimmermann and Fimm, 2005) + Edinburgh laterality questionnaire (Oldfield,1971) + hamilton and young's scale (Tohen et al., 2009) + Montreal Cognitive Assessment (MoCA) (Nasreddine et al., 2005) + experimental task (approach/ avoidance and affordance task).\n* Intelligence Quotient (IQ) test (PM38, Raven, 1960)\n* Mini International Neuropsychiatric Interview (MINI, Van Vliet et al., 2006)", 'armGroupLabels': ['patients']}, {'name': 'cognitive tasks', 'type': 'BEHAVIORAL', 'description': 'Healthy volunteers will perform only the cognitive tasks = reaction time alert TEA, Zimmermann and Fimm, 2005 + Edinburgh laterality questionnaire (Oldfield, 1971) + experimental task (approach/ avoidance and affordance task).', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Chu Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Catherine MASSOUBRE, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}