Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2026-02-25 @ 5:53 PM
Study NCT ID:
NCT03732092
Status:
COMPLETED
Last Update Posted:
2020-12-29
First Post:
2018-11-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Olfactory Stimulation on Diagnosis and Prognosis of DOC Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018458', 'term': 'Persistent Vegetative State'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014474', 'term': 'Unconsciousness'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2019-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-24', 'studyFirstSubmitDate': '2018-11-04', 'studyFirstSubmitQcDate': '2018-11-04', 'lastUpdatePostDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Coma Recovery Scale-Revised （CRS-R）', 'timeFrame': 'six months later', 'description': 'The CRS-R consists of 23 items grouped in six subscales addressing auditory, visual, motor, oromotor, communication and arousal functions. The higher items represent conscious related behaviour while the lower items for each sub-scale represent reflexive activity. Basis for scoring was the presence or absence of the specific behaviour in response to standard stimuli. Patients were followed up for 1, 3, and 6 months to track the prognosis of patients by CRS-R.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['disorders of consciousness', 'prognosis prediction', 'minimally conscious state', 'vegetative state', 'olfactory stimulation'], 'conditions': ['Minimally Conscious State', 'Vegetative State']}, 'referencesModule': {'references': [{'pmid': '25690545', 'type': 'RESULT', 'citation': 'Chiaravalloti A, Pagani M, Micarelli A, Di Pietro B, Genovesi G, Alessandrini M, Schillaci O. Cortical activity during olfactory stimulation in multiple chemical sensitivity: a (18)F-FDG PET/CT study. Eur J Nucl Med Mol Imaging. 2015 Apr;42(5):733-40. doi: 10.1007/s00259-014-2969-2. Epub 2015 Feb 18.'}, {'pmid': '35250440', 'type': 'DERIVED', 'citation': 'Wang J, Zhang S, Liu W, Zhang Y, Hu Z, Sun Z, Di H. Olfactory Stimulation and the Diagnosis of Patients With Disorders of Consciousness: A Double-Blind, Randomized Clinical Trial. Front Neurosci. 2022 Feb 17;16:712891. doi: 10.3389/fnins.2022.712891. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'Analyze the behavioral response of patients with disorders of consciousness through olfactory stimulation, compare the response of olfactory stimulation in patients with different consciousness, and analyze the impact of olfactory stimulation on diagnosis; After the first, third, and sixth months of initial enrollment, the recovery of prognosis was tracked by the Coma Recovery Scale-Revision (CRS-R).', 'detailedDescription': "Previous studies suggested that olfactory stimulus have some effect on some patients with disorders of consciousness. Then, the aim of the present study is to know the prognostic value of olfactory stimulation and the diagnosis for DOC patients. DOC patients were recruited (standard diagnosis procedure is 5 times CRS-R testing within 10 days). The different stimuli were as follows: 1) 1-octene-3-ol, odor. 2) pyridine, odor. 3) water. We presented these stimuli randomly, and we recorded the patient's CRS-R scale behavioral response and response to olfactory stimulation. Analyze the behavioral response of patients with disorders of consciousness through olfactory stimulation, compare the response of olfactory stimulation in patients with different consciousness, and analyze the impact of olfactory stimulation on diagnosis; After the first, third, and sixth months of initial enrollment, the recovery of prognosis was tracked by the Coma Recovery Scale-Revision (CRS-R)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with disorders of consciousness', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-65 years old;\n* non-acute phase;\n* after coma;\n* no nerve stimulation drugs within 48 hours before the implementation of the study;\n* no neuromuscular blockers within 24 hours before implementation\n\nExclusion Criteria:\n\n* history of forehead injury;\n* nasal fractures;\n* tracheotomy;\n* developmental mental or neurological diseases leading to recorded dysfunction;\n* severe fractures of the extremities.'}, 'identificationModule': {'nctId': 'NCT03732092', 'briefTitle': 'The Effects of Olfactory Stimulation on Diagnosis and Prognosis of DOC Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hangzhou Normal University'}, 'officialTitle': 'The Effects of Olfactory Stimulation on Diagnosis and Prognosis of Patients With Disorders of Consciousness', 'orgStudyIdInfo': {'id': '2018A04355'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with disorders of consciousness', 'description': 'Patients with disorders of consciousness from several brain injury, assessed by Coma Recovery Scale-Revised (CRS-R), have been clinically classified into coma, unresponsive wakefulness syndrome and minimally conscious state.', 'interventionNames': ['Diagnostic Test: Coma Recovery Scale-Revised']}], 'interventions': [{'name': 'Coma Recovery Scale-Revised', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients with disorders of consciousness were assessed by Coma Recovery Scale-Revised (CRS-R). In addition, we selected three stimuli: 1) 1-octene-3-ol, 2) pyridine, 3) water. We presented these three stimuli in front of the patients nose for 3 seconds.', 'armGroupLabels': ['patients with disorders of consciousness']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3100036', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'International Vegetative State and Consciousness Science Institute, Hangzhou Normal University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Patients with disorders of consciousness were assessed by Coma Di, Pro', 'role': 'STUDY_CHAIR', 'affiliation': 'International Vegetative State and Consciousness Science Institute, Hangzhou Normal University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jing Wang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jing Wang', 'investigatorAffiliation': 'Hangzhou Normal University'}}}}