Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2026-03-11 @ 5:02 PM
Study NCT ID:
NCT00224666
Status:
TERMINATED
Last Update Posted:
2007-01-11
First Post:
2005-09-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Cortex Stimulation in Neuropathic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 16}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2001-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-01', 'completionDateStruct': {'date': '2005-11'}, 'lastUpdateSubmitDate': '2007-01-09', 'studyFirstSubmitDate': '2005-09-16', 'studyFirstSubmitQcDate': '2005-09-16', 'lastUpdatePostDateStruct': {'date': '2007-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of 50% of EVS at 3 weeks'}], 'secondaryOutcomes': [{'measure': 'Efficacy of 50% of EVS at 6 months and 12 months'}]}, 'conditionsModule': {'keywords': ['Cortex stimulation ,Rebel neuropathic pains'], 'conditions': ['Rebel Neuropathic Pains']}, 'referencesModule': {'references': [{'pmid': '15572109', 'type': 'BACKGROUND', 'citation': "Drouot X, Oshino S, Jarraya B, Besret L, Kishima H, Remy P, Dauguet J, Lefaucheur JP, Dolle F, Conde F, Bottlaender M, Peschanski M, Keravel Y, Hantraye P, Palfi S. Functional recovery in a primate model of Parkinson's disease following motor cortex stimulation. Neuron. 2004 Dec 2;44(5):769-78. doi: 10.1016/j.neuron.2004.11.023."}, {'pmid': '15026508', 'type': 'BACKGROUND', 'citation': 'Lefaucheur JP, Drouot X, Menard-Lefaucheur I, Zerah F, Bendib B, Cesaro P, Keravel Y, Nguyen JP. Neurogenic pain relief by repetitive transcranial magnetic cortical stimulation depends on the origin and the site of pain. J Neurol Neurosurg Psychiatry. 2004 Apr;75(4):612-6. doi: 10.1136/jnnp.2003.022236.'}]}, 'descriptionModule': {'briefSummary': 'The pains chronic neurogeneses remain difficult to treat whatever are their origin and their localization. The pharmacological therapeutic arsenal answers only partially the symptomatology often very invalidating which these chronic painful patients present. Electric stimulations of the central nervous system currently validated, in particular of the posterior cords of marrow made a significant improvement in a certain number of indications. Nevertheless, considerable patients are not relieved significantly, in particular those presenting of the pains neurogeneses of central origin (syndromes thalamic for example). It is within this framework that recently the stimulation of the sensorimotor cortex developed.\n\nPrincipal objective: evaluation of the technique of stimulation under cortical on neuropathic pains .', 'detailedDescription': 'The pains chronic neurogeneses remain difficult to treat whatever are their origin and their localization. The pharmacological therapeutic arsenal answers only partially the symptomatology often very invalidating which these chronic painful patients present. Electric stimulations of the central nervous system currently validated, in particular of the posterior cords of marrow made a significant improvement in a certain number of indications. Nevertheless, considerable patients are not relieved significantly, in particular those presenting of the pains neurogeneses of central origin (syndromes thalamic for example). It is within this framework that recently the stimulation of the sensorimotor cortex developed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Neurofibromatosis,\n* Rebel chronic neuropathic pain with duration \\> 1 year and AVS \\> = 4\n\nExclusion Criteria:\n\n* Cancer\n* Epilepsy\n* Cognitive deterioration'}, 'identificationModule': {'nctId': 'NCT00224666', 'briefTitle': 'Efficacy of Cortex Stimulation in Neuropathic Pain', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Evaluation of the Effectiveness of Stimulation Cortex Sensorimotor for the Treatment of Rebel Neuropathic Pains', 'orgStudyIdInfo': {'id': 'P000901'}, 'secondaryIdInfos': [{'id': 'AOM98134'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Cortex stimulation', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94000', 'city': 'Créteil', 'country': 'France', 'facility': 'Hopital Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}], 'overallOfficials': [{'name': "N'GUYEN, Pr,MD,PhD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}}}}