Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT05017051
Status:
RECRUITING
Last Update Posted:
2022-12-21
First Post:
2021-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study for the Quantification in Ecological Conditions of Sensorimotor and Dysexecutive Disorders in Cerebral Palsy Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 442}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-20', 'studyFirstSubmitDate': '2021-08-19', 'studyFirstSubmitQcDate': '2021-08-19', 'lastUpdatePostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lowest number of errors on the executive tasks over the 4 visits', 'timeFrame': 'Until the end of the study (3 years)', 'description': 'An error is defined as: an omission, an addition, a substitution, an estimation error, a question or a commentary The number of errors will be calculated for each task at each visit. The lowest number will be retained to compare the 2 groups.'}], 'secondaryOutcomes': [{'measure': 'Lowest number of errors on the Lego model task over the 4 visits', 'timeFrame': 'Until the end of the study (3 years)', 'description': 'An error is defined as: an omission, an addition, a substitution, an estimation error, a question or a commentary\n\nThe number of errors will be calculated for the Lego model task at each visit. The lowest number will be retained to compare the 2 groups.'}, {'measure': 'Lowest number of errors on the chocolate cake task over the 4 visits', 'timeFrame': 'Until the end of the study (3 years)', 'description': 'An error is defined as: an omission, an addition, a substitution, an estimation error, a question or a commentary\n\nThe number of errors will be calculated for the chocolate cake task at each visit.\n\nThe lowest number will be retained to compare the 2 groups.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dysexecutive Syndrome']}, 'descriptionModule': {'briefSummary': 'Executive functions are defined as the mental functions necessary for an individual to adapt to a complex or new environment that requires freedom from automatic and routine behavior. Deficits in executive functions are described under the term "dysexecutive syndrome", and call into question the quality of social and professional life as well as the autonomy of patients.\n\nThe usual methods of identifying dysexecutive syndrome are based essentially on batteries of neuropsychological tests known as "paper and pencil". However, these tests may lack sensitivity, in that they assess the patient in a very structured setting, very different from real life conditions, which are full of distractions and choices to be made.\n\nEvaluations on real tasks are more rarely used but have the advantage of observing the difficulties encountered by a patient in everyday life.\n\nTwo tests of this type have been set up in the Neurology Department of the Hôpital d\'Instruction des Armées Percy, and are integrated into the routine care of patients with a dysexecutive syndrome.\n\nFor this purpose, a room in the department has been set up as a studio in order to reproduce as much as possible an everyday life environment, in which executive functions, fine motor skills, neurovegetative functions, emotional state, posture, locomotor skills and visual information capture can be measured ecologically.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is composed of 2 groups:\n\n* a group of patients with dysexecutive syndrome\n* a group of healthy subjects', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a dysexecutive syndrome OR healthy subjects\n* Over 18 years-old\n\nExclusion Criteria:\n\n* Patients\n\n * Psychiatric pathology (except for Post-Traumatic Stress Disorder)\n * Pregnant or breastfeeding woman\n* Healthy subjects\n\n * Neurologic or psychiatric pathology\n * Pregnant or breastfeeding woman'}, 'identificationModule': {'nctId': 'NCT05017051', 'acronym': 'SDS2', 'briefTitle': 'Study for the Quantification in Ecological Conditions of Sensorimotor and Dysexecutive Disorders in Cerebral Palsy Patients', 'organization': {'class': 'OTHER', 'fullName': 'Direction Centrale du Service de Santé des Armées'}, 'officialTitle': 'Study for the Quantification in Ecological Conditions of Sensorimotor and Dysexecutive Disorders in Cerebral Palsy Patients', 'orgStudyIdInfo': {'id': '2018PPRC34'}, 'secondaryIdInfos': [{'id': '2021-A00087-34', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Dysexecutive patients', 'description': 'Patients with dysexecutive syndrome', 'interventionNames': ['Behavioral: Chocolate cake', 'Behavioral: Lego model', 'Device: Measurement of sensorimotor abilities', 'Other: Measurement of facial expression of emotions']}, {'label': 'Healthy subjects', 'description': 'Healthy subjects to be used as control group', 'interventionNames': ['Behavioral: Chocolate cake', 'Behavioral: Lego model', 'Device: Measurement of sensorimotor abilities', 'Other: Measurement of facial expression of emotions']}], 'interventions': [{'name': 'Chocolate cake', 'type': 'BEHAVIORAL', 'description': 'The participants will have to make a chocolate cake following an imposed recipe at 4 visits (initially (M0), after 12 months (M12), after 24 months (M24) and after 36 months (M36)).', 'armGroupLabels': ['Dysexecutive patients', 'Healthy subjects']}, {'name': 'Lego model', 'type': 'BEHAVIORAL', 'description': 'The participants will have to build a Lego model at 4 visits (M0, M12, M24 and M36).', 'armGroupLabels': ['Dysexecutive patients', 'Healthy subjects']}, {'name': 'Measurement of sensorimotor abilities', 'type': 'DEVICE', 'description': 'The measurement of sensorimotor abilities is based on a multi-sensor device called Smart Flat specifically designed for this study at 4 visits (M0, M12, M24 and M36).', 'armGroupLabels': ['Dysexecutive patients', 'Healthy subjects']}, {'name': 'Measurement of facial expression of emotions', 'type': 'OTHER', 'description': 'Participants will have to evoke an emotionally charged autobiographical story by modulating facial expressions through a mirror at 4 visits (M0, M12, M24 and M36).', 'armGroupLabels': ['Dysexecutive patients', 'Healthy subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92140', 'city': 'Clamart', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Flavie BOMPAIRE, MD', 'role': 'CONTACT', 'email': 'flavie.bompaire@intradef.gouv.fr', 'phone': '141466877', 'phoneExt': '+33'}], 'facility': "Hôpital d'Instruction des Armées Percy", 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}], 'centralContacts': [{'name': 'Flavie BOMPAIRE, MD', 'role': 'CONTACT', 'email': 'flavie.bompaire@intradef.gouv.fr', 'phone': '141466877', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Direction Centrale du Service de Santé des Armées', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}