Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-01-02 @ 1:50 PM
Study NCT ID:
NCT02858466
Status:
TERMINATED
Last Update Posted:
2020-09-28
First Post:
2016-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Structural and Functional Brain Reorganization in Neuropathic Pain: Basal State of Local Cerebral Blood Flow and Functional Connectivity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'whyStopped': 'failure to recruit', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-03-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-24', 'studyFirstSubmitDate': '2016-07-25', 'studyFirstSubmitQcDate': '2016-08-03', 'lastUpdatePostDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cerebral blood flow', 'timeFrame': 'at baseline', 'description': 'quantified with MRI scan'}], 'secondaryOutcomes': [{'measure': 'rate of grey matter', 'timeFrame': 'at baseline', 'description': 'difference between groups'}, {'measure': 'structure of the networks', 'timeFrame': 'at baseline', 'description': 'Determine if structure of the networks is different between patients and controls.\n\nMeasured with MRI scan.'}, {'measure': 'connection of the networks', 'timeFrame': 'at baseline', 'description': 'Determine if connection of the networks is different between patients and controls.\n\nMeasured with MRI scan.'}, {'measure': 'cortical loss', 'timeFrame': 'at baseline', 'description': 'Assess the cortical loss of the patient group compared to controls. Measured with MRI scan.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neuropathic Pain']}, 'descriptionModule': {'briefSummary': 'Neuropathic pain is a medical condition involving allodynia (painful perceptions in response to stimuli that normally are not) and spontaneous pain (occurring at rest, without stimulation).\n\nThis pain is secondary to nervous system injury affecting the sensory system. The lesion is either at the nerve endings of the spinal cord or brain.\n\nIt induces a loss of sensitivity and likely reorganization of brain activity that are causing pain and which are the subject of this study.\n\nPrevious studies in functional neuroimaging has focused on brain areas activated during allodynic stimuli compared to non-painful stimuli. The abnormalities have been reported, but it was not possible to conclude formally. The authors failed to assess the part of the effect of the loss of sensory afferents (deafferentation) and the basal brain function.\n\nIndeed, the operation without any sensory stimulation is not known yet is the initial level of activity which is the benchmark for studying brain function during stimulation. The objective of this study is to understand what are the cortical systems of allodynic dysfunctional in patients compared with controls at baseline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for patients :\n\n* major\n* with nervous pain : chronic or peripheric\n* treatment not stable opioid since one week\n* signed consent\n\nInclusion Criteria for witnesses :\n\n* major\n* without chronic pain\n* signed consent\n\nExclusion Criteria for 2 groups :\n\n* severe psychiatric history\n* presence of an active nervous lesion\n* subject with morphine treatment\n* contraindication to MRI scan'}, 'identificationModule': {'nctId': 'NCT02858466', 'acronym': 'CONNECT', 'briefTitle': 'Structural and Functional Brain Reorganization in Neuropathic Pain: Basal State of Local Cerebral Blood Flow and Functional Connectivity', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Structural and Functional Brain Reorganization in Neuropathic Pain: Basal State of Local Cerebral Blood Flow and Functional Connectivity', 'orgStudyIdInfo': {'id': '1308144'}, 'secondaryIdInfos': [{'id': '2013-A01440-45', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'peripheric nervous lesion', 'description': 'MRI scan', 'interventionNames': ['Radiation: MRI scan']}, {'type': 'EXPERIMENTAL', 'label': 'medullar or encephalic lesion', 'description': 'MRI scan', 'interventionNames': ['Radiation: MRI scan']}, {'type': 'OTHER', 'label': 'control group', 'description': 'MRI scan', 'interventionNames': ['Radiation: MRI scan']}], 'interventions': [{'name': 'MRI scan', 'type': 'RADIATION', 'armGroupLabels': ['control group', 'medullar or encephalic lesion', 'peripheric nervous lesion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42000', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU de SAINT-ETIENNE', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Roland PEYRON, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de SAINT-ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}