Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2026-01-01 @ 5:06 PM
Study NCT ID:
NCT02759068
Status:
COMPLETED
Last Update Posted:
2018-11-30
First Post:
2016-04-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Beneficial Effects of Preference on Behavior in DOC Patients (COGNICOMA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D018458', 'term': 'Persistent Vegetative State'}], 'ancestors': [{'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D014474', 'term': 'Unconsciousness'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013016', 'term': 'Sound'}, {'id': 'D009812', 'term': 'Odorants'}], 'ancestors': [{'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D055669', 'term': 'Ecological and Environmental Phenomena'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-28', 'studyFirstSubmitDate': '2016-04-26', 'studyFirstSubmitQcDate': '2016-04-28', 'lastUpdatePostDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive Function measured using the Coma Recovery Scale', 'timeFrame': 'within the first 30 days', 'description': 'Improvement of the score following sound stimuli and/or preferred stimuli'}], 'secondaryOutcomes': [{'measure': 'Reaction time', 'timeFrame': 'within the first 30 days', 'description': 'Faster reaction following sound stimuli and/or preferred stimuli'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vegetative state', 'minimally conscious state', 'music', 'preference'], 'conditions': ['Disorders of Consciousness']}, 'descriptionModule': {'briefSummary': 'Preferred music improves cognitive function in patients with disorders of consciousness (DOC). However, it is still unknown whether it is a general effect of music (because of its acoustic features) or an autobiographical effect (because of its emotional and meaningful contents).\n\nThe aim of the present study was to investigate the effect of sensory modality (auditory versus olfactory) and preference (preferred versus neutral) of the testing context on the performance of four items from the coma recovery scale-revised'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Disorders of consciousness (Traumatic brain injury, stroke or anoxic encephalopathy)\n* Coma diagnosis (Plum and Posner, 1966), vegetative state (Task Force, 1994) or minimally conscious state (Giacino, Ashwal et al. 2002)\n* Lack of autonomic crisis since one week minimum\n* Medical condition considered stable\n* Patients who do not present hearing loss. Peaks I and II of Brainstem Auditory Evoked Potentials (BAEP) will be normal.\n\nExclusion Criteria:\n\n* Hearing Problem\n* Uncontrolled Epilepsy\n* Autonomic crises\n* Medical unstable state\n* Pregnant or likely to be (interrogation data) or breastfeeding woman'}, 'identificationModule': {'nctId': 'NCT02759068', 'acronym': 'COGNICOMA', 'briefTitle': 'Beneficial Effects of Preference on Behavior in DOC Patients (COGNICOMA)', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Beneficial Effects of Preference on Behavior', 'orgStudyIdInfo': {'id': '2014-882'}, 'secondaryIdInfos': [{'id': '2014-A01062-45', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients behavior', 'description': 'Behavior (motor reaction) to stimuli (sounds and odors)', 'interventionNames': ['Behavioral: sounds and odors']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'healthy volunteers behavior', 'description': 'Behavior (motor reaction) to stimuli (sounds and odors)', 'interventionNames': ['Behavioral: sounds and odors']}], 'interventions': [{'name': 'sounds and odors', 'type': 'BEHAVIORAL', 'description': 'presentation of sounds and odors', 'armGroupLabels': ['healthy volunteers behavior', 'patients behavior']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69230', 'city': 'Saint-Genis-Laval', 'country': 'France', 'facility': 'Hospices Civils de Lyon - Hôpital Henry Gabrielle & Hôpital Neurologique', 'geoPoint': {'lat': 45.69542, 'lon': 4.79316}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}