Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2026-01-21 @ 8:06 PM
Study NCT ID:
NCT02078206
Status:
COMPLETED
Last Update Posted:
2022-03-09
First Post:
2014-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Neurocognitive Rehabilitation in Intensive Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D003693', 'term': 'Delirium'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2020-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-08', 'studyFirstSubmitDate': '2014-02-28', 'studyFirstSubmitQcDate': '2014-03-03', 'lastUpdatePostDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Attention', 'timeFrame': 'Hospital discharge and 3-months after hospital discharge', 'description': '* Verbal attention: Digits Forward subtest of the WAIS III (Wechsler, 1999)\n* Visual attention: Spatial Localization Forward subtest of the WMS III (Wechsler, 1999)\n* Sustained/Selective attention: Continuous Performance Test (Conners, 1992)'}, {'measure': 'Memory', 'timeFrame': 'Hospital discharge and 3-months after hospital disharge', 'description': '* Verbal learning and memory: Auditory Verbal Learning Test (Rey, 1964)\n* Visual learning and memory: 10/36 Spatial Recall Test (Rao, 1992)\n* Visual recognition: Benton Visual Retention Test (Benton, 1983)'}, {'measure': 'Executive Functions', 'timeFrame': 'Hospital discharge and 3-months after hospital discharge', 'description': "* Stimuli alternation and sequencing: Trail Making Test A-B (Mimeo \\& Manga, 1999)\n* Automatic inhibition response: Stroop Test (Golden \\& Charles, 1978)\n* Visual planning: Tower of London (Shallice, 1982).\n* Phonetic verbal fluency: FAS test (Spreen and Benton, 1995)\n* Semantic verbal fluency: Animals 1' (Benton \\& Hamsher, 1976)"}, {'measure': 'Speed processing', 'timeFrame': 'Hospital discharge and 3-months after hospital discharge', 'description': '\\- Information processing speed: Symbol Search subtest of the WAIS III (Wechsler, 1999)'}, {'measure': 'Psychopathological status', 'timeFrame': 'Hospital discharge and 3-monts after hospital discharge', 'description': '* Depression: Hamilton Depression Rating Scale (HDRS) (Hamilton, 1960)\n* Anxiety: Hamilton Anxiety Rating Scale (HAM-A) (Hamilton, 1959)'}, {'measure': 'Functional Status', 'timeFrame': 'hospital discharge and 3-months after hospital discharge', 'description': '* Quality of life questionnaire: Satisfaction and Pleasure (Q-LES-Q) (Endicott, J., Nee, J., Harrison, W. \\& Blumenthal, R., 1993)\n* Lawton and Brody Functional Scale (1969)'}], 'secondaryOutcomes': [{'measure': 'Delirium', 'timeFrame': 'Every day during ICU stay', 'description': 'Number of episodes and duration of delirium: Confusional Assessment Method for Intensive Care Unit (CAM-ICU)'}]}, 'conditionsModule': {'keywords': ['Critical illness', 'Neurocognition', 'Neurocognitive stimulation', 'Delirium', 'Virtual Reality', 'cognitive', 'rehabilitation', 'ICU'], 'conditions': ['Critical Illness']}, 'referencesModule': {'references': [{'pmid': '28770543', 'type': 'DERIVED', 'citation': 'Turon M, Fernandez-Gonzalo S, Jodar M, Goma G, Montanya J, Hernando D, Bailon R, de Haro C, Gomez-Simon V, Lopez-Aguilar J, Magrans R, Martinez-Perez M, Oliva JC, Blanch L. Feasibility and safety of virtual-reality-based early neurocognitive stimulation in critically ill patients. Ann Intensive Care. 2017 Dec;7(1):81. doi: 10.1186/s13613-017-0303-4. Epub 2017 Aug 2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to assess the efficacy of an early neurocognitive intervention for ICU patients, in terms of psychopathological, neuropsychological and functional improvement. The treatment is supported in an interactive advanced computing platform that includes the continuous biomedical registration of the patients and a virtual reality software specifically designed for critical patients.\n\nThe investigators expect an improvement in neuropsychological, psychopathological and functional status at hospital discharge and 3 months follow-up in those patients that have received the early neurocognitive intervention comparing with patients treated as usual. Furthermore the investigators expect a decrease of episodes and/or duration of delirium in ICU patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged between 18 and 80 years\n* Patients receiving mechanical ventilation for at least 24 hours\n* Patients scoring more than 8 on the Glasgow Coma Scale (GCS) and more than 2 on the Sedation Agitation Scale (SAS)\n* Patients haemodynamically stable\n* Informed consent signed by the closest relatives.\n\nExclusion Criteria:\n\n* Patients with previous neurologic pathology or focal brain injury before ICU admission\n* Patients with serious psychiatric pathology (major depression, psychosis, bipolar disease) or mentally retarded\n* Patients with sensorial alterations needed to interact with the neurocognitive stimulation programme\n* patients whose closest relatives refuse the subject to be included in the study.'}, 'identificationModule': {'nctId': 'NCT02078206', 'acronym': 'ENRIC', 'briefTitle': 'Early Neurocognitive Rehabilitation in Intensive Care', 'organization': {'class': 'OTHER', 'fullName': 'Corporacion Parc Tauli'}, 'officialTitle': 'Early Neurocognitive Rehabilitation in Intensive Care', 'orgStudyIdInfo': {'id': 'FPT-2013/057'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neurocognitive stimulation', 'description': 'Intervention of experimental group consists in a neurocognitive stimulation treatment. Using kinect technology, patient can interact with a virtual environment where different cognitive tasks have to be resolved.', 'interventionNames': ['Other: Neurocognitive stimulation']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment as usual'}], 'interventions': [{'name': 'Neurocognitive stimulation', 'type': 'OTHER', 'armGroupLabels': ['Neurocognitive stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08208', 'city': 'Sabadell', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Corporació Parc Taulí', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}], 'overallOfficials': [{'name': 'Lluis Blanch, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fundació Parc Taulí'}, {'name': 'Antoni Artigas, Phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Corporació Parc Taulí- Critical Care Unit chair'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corporacion Parc Tauli', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundació La Marató de TV3', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Lluis Blanch', 'investigatorAffiliation': 'Corporacion Parc Tauli'}}}}