Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-02-27 @ 10:34 AM
Study NCT ID:
NCT00241566
Status:
COMPLETED
Last Update Posted:
2010-01-20
First Post:
2005-10-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Economic Medical Evaluation of Treatment of the Neuropathic Pain Rebel by Cortical Stimulation
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-19', 'studyFirstSubmitDate': '2005-10-17', 'studyFirstSubmitQcDate': '2005-10-18', 'lastUpdatePostDateStruct': {'date': '2010-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cost of treatment of this pathology'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the pain when the electric stimulation is off or on (during one month for each one). Using Visual Analogic Scale.'}]}, 'conditionsModule': {'keywords': ['Neuropathic pain', 'Electric cortical stimulation', 'Economic Medical evaluation'], 'conditions': ['Neuropathic Pain Rebel']}, 'descriptionModule': {'briefSummary': 'All neuropathic chronicle pains are difficult to treat. Currently many patients are not relieved by electric stimulations of central nervous system, existing. Recently cortical stimulation had a development important and benefit effects are proven. In this study we evaluate medico-economic impact of this treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of pain caused by lesion of central or peripheral nervous system\n* Pain persistent since one year at least\n* Pain untreated with 3 different antalgic treatments\n\nExclusion Criteria\n\n* Pain linked t a malignant affection\n* patient \\< 18 years-old'}, 'identificationModule': {'nctId': 'NCT00241566', 'briefTitle': 'Economic Medical Evaluation of Treatment of the Neuropathic Pain Rebel by Cortical Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Economic Medical Evaluation of Treatment of the Neuropathic Pain Rebel by Cortical Stimulation', 'orgStudyIdInfo': {'id': 'CHU63-0002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'implantation of stimulator', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'state': 'Auvergne', 'country': 'France', 'facility': 'Clermont-Ferrand UH', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '94010', 'city': 'Créteil', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Neurosurgery - Henri Mondor Hospital', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}], 'overallOfficials': [{'name': 'Jean-Jacques Lemaire', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clermont-Ferrand UH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Pr Jean-Jacques LEMAIRE', 'oldOrganization': 'CHU Clermont-Ferrand'}}}}