Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-04-21 @ 9:35 AM
Study NCT ID:
NCT02560233
Status:
WITHDRAWN
Last Update Posted:
2024-12-17
First Post:
2015-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modulating Stress-Reactivity by Real-Time Multimodal Functional Neuroimaging Based Neurofeedback
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['South Korea']}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No subjects were recruited', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-12', 'studyFirstSubmitDate': '2015-08-10', 'studyFirstSubmitQcDate': '2015-09-24', 'lastUpdatePostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Functional connectivity', 'timeFrame': 'At study day one', 'description': 'Connectivity of brain activity determined by fMRI signal'}, {'measure': 'Feedback on adverse events during the scanner training', 'timeFrame': 'At study day one', 'description': 'Number of subjects reporting an adverse event'}], 'primaryOutcomes': [{'measure': 'Hypothalamic-pituitary-adrenal (HPA) axis reactivity', 'timeFrame': 'At study day one', 'description': 'Assessed via salivary cortisol'}, {'measure': 'Blood oxygenation level dependent signal of the target brain region of interest', 'timeFrame': 'At study day one', 'description': 'Blood oxygenation level dependent (BOLD) signal assessed via functional magnetic resonance imaging, expressed in relative BOLD signal intensity'}], 'secondaryOutcomes': [{'measure': 'Psychophysiological stress reactivity - blood pressure', 'timeFrame': 'At study day one', 'description': 'Assessed via blood pressure'}, {'measure': 'Psychophysiological stress reactivity - heart rate variability', 'timeFrame': 'At study day one', 'description': 'Assessed via heart rate variability'}, {'measure': 'Psychophysiological stress reactivity - heart rate', 'timeFrame': 'At study day one', 'description': 'Assessed via heart rate'}, {'measure': 'Subjective stress reactivity', 'timeFrame': 'At study day one', 'description': 'Assessed via Visual Analog Scale'}, {'measure': 'Electrical activity of the brain', 'timeFrame': 'At study day one', 'description': 'Assessed via electroencephalography (EEG)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neurofeedback', 'Stress', 'fMRI', 'Real-time fMRI Neurofeedback', 'Anterior cingulate cortex', 'Hypothalamic-pituitary-adrenal axis', 'Cortisol', 'EEG', 'Heart rate variability', 'Blood pressure', 'Simultaneous EEG/fMRI'], 'conditions': ['Stress', 'Pituitary-Adrenal System']}, 'descriptionModule': {'briefSummary': 'The overall goal of the outlined study is to establish a Real-Time (RT) functional Magnetic Resonance Imaging (fMRI) Neurofeedback (NF) (RT-fMRI-NF) protocol aiming at modulating neural, endocrine, and subjective reactivity to psychosocial stress.', 'detailedDescription': 'The overall goal of the outlined study is to establish an RT-fMRI-NF protocol aiming at modulating neural, endocrine, and subjective reactivity to psychosocial stress. More specifically, the investigators pursue the following goals: a) to evaluate whether neural and subjective stress-reactivity can be modified by training volitional control over targeted brain activity by means of RT-fMRI-NF; b) to evaluate whether neuromodulation by means of RT-fMRI-NF can be used as a new way to modulate hormone-release into the periphery; and c) to evaluate whether the efficacy of neuromodulation by RT-fMRI-NF can also be reflected on EEG data as well as the autonomic nervous system (ANS) measured by heart rate variability (HRV).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sufficient spoken and written knowledge of English\n* Right-handedness\n* Ability to participate in study procedures\n\nExclusion Criteria:\n\n* Present or past psychological or psychiatric therapy\n* Major or unstable general medical conditions\n* Presence of cardiovascular disease\n* Current intake of any medication interfering hormonal assessments\n* History of major cerebral injury\n* Medical MRI contraindication'}, 'identificationModule': {'nctId': 'NCT02560233', 'briefTitle': 'Modulating Stress-Reactivity by Real-Time Multimodal Functional Neuroimaging Based Neurofeedback', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Modulating Stress-Reactivity by Real-Time Multimodal Functional Neuroimaging Based Neurofeedback', 'orgStudyIdInfo': {'id': 'GRNP_2013S1A2A2035364_1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Contingent', 'description': 'Contingent RT-fMRI-NF', 'interventionNames': ['Other: Contingent RT-fMRI-NF']}, {'type': 'SHAM_COMPARATOR', 'label': 'Non-contingent', 'description': 'Sham RT-fMRI-NF', 'interventionNames': ['Other: Sham RT-fMRI-NF']}], 'interventions': [{'name': 'Contingent RT-fMRI-NF', 'type': 'OTHER', 'description': 'Subjects are provided with contingent RT-fMRI-NF of brain activity in the target region of interest.', 'armGroupLabels': ['Contingent']}, {'name': 'Sham RT-fMRI-NF', 'type': 'OTHER', 'description': 'Subjects are provided with sham RT-fMRI-NF of brain activity of previously recorded subject.', 'armGroupLabels': ['Non-contingent']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Marion Tegethoff, PD Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Basel'}, {'name': 'Jong-Hwan Lee, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea University'}, {'name': 'Gunther Meinlschmidt, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Basel; Ruhr-University Bochum'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Basel', 'class': 'OTHER'}, {'name': 'Korea University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}