Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2025-12-25 @ 4:24 PM
Study NCT ID:
NCT05003557
Status:
COMPLETED
Last Update Posted:
2023-02-28
First Post:
2021-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognostic Outcome Score in Functional Neurological Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003291', 'term': 'Conversion Disorder'}], 'ancestors': [{'id': 'D013001', 'term': 'Somatoform Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-27', 'studyFirstSubmitDate': '2021-07-06', 'studyFirstSubmitQcDate': '2021-08-05', 'lastUpdatePostDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical evolution according the Clinical Global Impression scale', 'timeFrame': 'continuously through study completion, an average of 1 year', 'description': 'Using a Clinical Global Impression (CGI-I) scale on FNDstatus, subjects will be classified into two groups by the two principal investigators (Dr. Vercueil, M. Bratanov): the first with a favorable evolution (disappearance of symptoms at the last follow-up, low health care consumption, favorable self-assessment of health status, persistence of symptoms at a low level of disability, satisfactory social and professional integration), and the second with an unfavorable evolution (persistence of symptoms at a disabling level, high health care consumption, unfavorable self-assessment of health status, lack of social and professional integration, multiple medical consultations)'}], 'secondaryOutcomes': [{'measure': 'Quality of life of each patient', 'timeFrame': 'continuously through study completion, an average of 1 year', 'description': 'using the 36-Item Short Form Survey (SF-36) Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved.All items are scored so that a high score defines a more favorable health state.'}, {'measure': 'Illness perception as reported by each patient', 'timeFrame': 'continuously through study completion, an average of 1 year', 'description': 'Using the Revised Illness Perception Questionnaire(IPQ-R)\n\nCoding:\n\nfor identity scale yes = 1; no = 0 for other items: strongly disagree =1, disagree =2, neither agree or disagree = 3, agree = 4, strongly agree = 5\n\nHigh scores on the identity, timeline, consequences, and cyclical dimensions represent strongly held beliefs about the number of symptoms attributed to the illness, the chronicity of the condition, the negative consequences of the illness, and the cyclical nature of the condition.\n\nHigh scores on the personal control, treatment control and coherence dimensions, represent positive beliefs about the controllability of the illness and a personal understanding of the condition.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['psychogenic'], 'conditions': ['Functional Neurological Symptom Disorder']}, 'descriptionModule': {'briefSummary': 'Monocentric retrospective observational cohort study, using a consecutive series of patients hospitalized for FND from 2012 to 2015 in the neurology department A of the Grenoble Alpes University Hospital. During the discharge staff, an estimation of different prognostic factors had been performed in a consensual way by the medical team for all subjects. It is possible to calculate a score (POS) retrospectively from the data collected during the staff. The following items were evaluated on a Likert scale from 1 to 5: quality of adherence to the diagnosis, presence of a current medical treatment, presence of a similar history, duration of evolution of the disorders presented, ability to verbalize, presence of a social adaptation to the disorders, access to psychiatric care.\n\nThe aim of the study will be to study the properties of the calculated score according to the evolution of the patients. The investigators will retrospectively collect information from the medical records. In addition, the evolution of the disorder since the initial hospitalization will be analyzed via a self-evaluation by the subjects and the study of the current medical records.\n\nThe investigators will also collect information on the quality of life of the patients in the cohort and their perception of the disease at present.\n\nUsing a Clinical Global Impression (CGI-I) scale on FNDstatus, subjects will be classified into two groups by the two principal investigators (Dr. Vercueil, M. Bratanov): the first with a favorable evolution (disappearance of symptoms at the last follow-up, low health care consumption, favorable self-assessment of health status, persistence of symptoms at a low level of disability, satisfactory social and professional integration), and the second with an unfavorable evolution (persistence of symptoms at a disabling level, high health care consumption, unfavorable self-assessment of health status, lack of social and professional integration, multiple medical consultations). The prognostic properties of the POS score will be then studied in order to establish an ROC curve that will allow to classify patients in the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients hospitalized in neurology ward from 2012 to 2015 and presenting with FND', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female gender\n* Hospitalization in Neurology Department A from 2012 to 2015 with a final retained diagnosis of NFT\n* POS score at time of hospitalization available\n\nExclusion Criteria:\n\n* Patient under legal protection\n* Inability to complete a self-questionnaire\n* Minor subjects'}, 'identificationModule': {'nctId': 'NCT05003557', 'acronym': 'POSiF', 'briefTitle': 'Prognostic Outcome Score in Functional Neurological Disorders', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': "Facteurs Pronostiques Des Troubles Fonctionnels Neurologiques : étude rétrospective et évaluation d'un Score", 'orgStudyIdInfo': {'id': '38RC21.167'}, 'secondaryIdInfos': [{'id': '2021-A01181-40', 'type': 'OTHER', 'domain': 'ID RCB'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Questionnaire administration', 'type': 'OTHER', 'description': '3 different questionnaires are going to be administered to each participant,\n\n* concerning the current health situation\n* the SF 36\n* the IPQ-R questionnaire'}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'Chu Grenoble Alpes', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'Laurent Vercueil, MD; PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Grenoble'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}