Ignite Creation Date:
2025-12-25 @ 1:42 AM
Ignite Modification Date:
2026-02-03 @ 8:22 AM
Study NCT ID:
NCT02695394
Status:
COMPLETED
Last Update Posted:
2020-07-17
First Post:
2016-02-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Emotional Processing in Multiple Sclerosis / Clinically Isolated Syndrome: A Neuropsychological fMRI-study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-15', 'studyFirstSubmitDate': '2016-02-11', 'studyFirstSubmitQcDate': '2016-02-24', 'lastUpdatePostDateStruct': {'date': '2020-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Emotional modulation of motor response time', 'timeFrame': '1 day', 'description': 'Δ (\\[Response time following neutral stimuli\\] - \\[Response time following emotional stimuli\\])'}, {'measure': 'Emotional memory performance', 'timeFrame': '1 day', 'description': '%-correct recognized emotional and neutral stimuli'}, {'measure': 'Emotional experience', 'timeFrame': '1 day', 'description': 'Subjective valence and arousal ratings of emotional and neutral stimuli'}], 'secondaryOutcomes': [{'measure': 'BOLD-fMRI brain responses during emotional processing', 'timeFrame': '1 day'}, {'measure': 'Expanded Disability Status Scale (EDSS)', 'timeFrame': '1 day'}, {'measure': 'Multiple Sclerosis Functional Composite (MSFC)', 'timeFrame': '1 day'}, {'measure': 'Short Form Health Survey (SF-36)', 'timeFrame': '1 day'}, {'measure': 'Satisfaction With Life Scale (SWLS)', 'timeFrame': '1 day'}, {'measure': 'Paced Auditory Serial Addition Test (PASAT)', 'timeFrame': '1 day'}, {'measure': 'Serial Reaction Time (SRT) Task', 'timeFrame': '1 day'}, {'measure': 'Symbol Digit Modalities Test (SDMT)', 'timeFrame': '1 day'}, {'measure': 'Beck depression inventory BDI-2', 'timeFrame': '1 day'}, {'measure': 'Positive and Negative Affect Schedule (PANAS)', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis (MS)', 'Clinically Isolated Syndrome (CIS)']}, 'referencesModule': {'references': [{'pmid': '32307769', 'type': 'RESULT', 'citation': 'Halbig TD, Wustenberg T, Giess RM, Kunte H, Bellmann-Strobl J, Ruprecht K, Paul F. Emotional experience in patients with clinically isolated syndrome and early multiple sclerosis. Eur J Neurol. 2020 Aug;27(8):1537-1545. doi: 10.1111/ene.14269. Epub 2020 Jun 12.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this prospective non-interventional neuropsychological one visit study involving functional MRI (fMRI) is to ascertain emotional processing in patients with Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS) compared to healthy control subjects.\n\nIn different experiments, the modulation of cognitive and motor responses by visual emotional information and the ability to discriminate visual emotional stimuli will be tested using experimental behavioral paradigms. Furthermore, functional connectivity and - using fMRI - activations of brain regions known to be involved with emotional processing will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '84 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be selected from a academic medical center MS outpatient clinic.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years and ≤ 85 years\n* Right handed\n* For patients: Diagnosis of CIS or diagnosis of MS since ≤5 years\n\nExclusion Criteria:\n\n* Cognitive deficits as determined by a MMSE Score \\< 25/30\n* Depression as determined by a HADS-D Score \\> 7\n* Anxiety as determined by a HADS-A Score \\> 7\n* Physical disabilities interfering with the study procedures or impacting outcome measures\n* Clinically significant diseases within 7 days prior to the study evaluations\n* Contraindications against cranial MRI without contrast'}, 'identificationModule': {'nctId': 'NCT02695394', 'briefTitle': 'Emotional Processing in Multiple Sclerosis / Clinically Isolated Syndrome: A Neuropsychological fMRI-study', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'orgStudyIdInfo': {'id': 'EA1/126/15'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MS / CIS'}, {'label': 'Healthy controls'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Unversitätsmedizin Berlin; NeuroCure Clinical Research Center NCRC', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Friedemann Paul, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charité Unversitätsmedizin Berlin, NeuroCure Clinical Research Center NCRC'}, {'name': 'Thomas D. Hälbig, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charité Unversitätsmedizin Berlin, NeuroCure Clinical Research Center NCRC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'NeuroCure Clinical Research Center, Charite, Berlin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'PD Dr. Thomas Hälbig', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}