Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-01-03 @ 5:56 PM
Study NCT ID:
NCT03259451
Status:
WITHDRAWN
Last Update Posted:
2018-04-12
First Post:
2017-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Repetitive Transcranial Magnetic Stimulation in the Treatment of Chronic Neuropathic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'No recruitment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-11', 'studyFirstSubmitDate': '2017-08-21', 'studyFirstSubmitQcDate': '2017-08-21', 'lastUpdatePostDateStruct': {'date': '2018-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the efficacy of rTMS in the treatment of chronic neuropathic pain in a short term', 'timeFrame': 'Day 7', 'description': 'Improvement of pain symptoms by at least 30% on the numerical scale'}, {'measure': 'Evaluation of the efficacy of rTMS in the treatment of chronic neuropathic pain in a short term (≤ 1 month)', 'timeFrame': 'Month 1', 'description': 'Improvement of pain symptoms by at least 30% on the numerical scale'}], 'secondaryOutcomes': [{'measure': 'Evaluate the effectiveness of rTMS in the treatment of long-term chronic neuropathic pain (> 6 months)', 'timeFrame': 'Month 6', 'description': 'Persistence of at least 30% improvement in pain symptoms on a numerical scale at the end of the sixth month (M6)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Neuropathic Pain']}, 'descriptionModule': {'briefSummary': 'A retrospective, monocentric, observational, descriptive, open study of a cohort of 149 patients from January 2014 to December 2015', 'detailedDescription': 'Neuropathic pain is a public health problem because of its prevalence reaching nearly 7% of the general population and the effectiveness of current treatments often remains incomplete: only 30-40% of patients are relieved of 50% of their pain by a pharmacological approach.\n\nAs early as the 1990s, stimulation of the motor cortex by implanted electrodes made it possible to successfully treat certain chronic refractory neuropathic pain. In 1995 it was reported that the application of repeated shocks by transcranial magnetic stimulation of the motor cortex could induce an analgesic effect in a patient suffering from neuropathic pain.\n\nThis technique has proved its analgesic efficacy after an induction treatment over 5 days, in the context of chronic pain (neuropathic or fibromyalgia), but all the patients are not responders and there is currently, Of predictive criteria for response. It seems important to continue studies on this non-medicinal, non-invasive therapy with no significant adverse effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with chronic neuropathic pain', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- patient older than 18 years old with chronic neuropathic pain who are resistant to drug therapy for which treatment with rTMS is indicated between January 2014 and December 2015\n\nExclusion Criteria:\n\n* Patient less than 18 years old\n* Pregnant woman\n* Non-neuropathic pain\n* Pain \\<6 months\n* Unbalanced epilepsy\n* Patient with a contraindication for cerebral MRI (cochlear implant, ocular metallic foreign bodies, patient with a pacemaker, mechanical valve)\n* Psychiatric pathology\n* Person subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty'}, 'identificationModule': {'nctId': 'NCT03259451', 'acronym': 'rTMS-CIC', 'briefTitle': 'Effectiveness of Repetitive Transcranial Magnetic Stimulation in the Treatment of Chronic Neuropathic Pain', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'Effectiveness of Repetitive Transcranial Magnetic Stimulation in the Treatment of Chronic Neuropathic Pain: Retrospective Study on a Cohort of 149 Patients at Rennes University Hospital, From January 2014 to December 2015', 'orgStudyIdInfo': {'id': '35RC16_3045_rTMS-CIC'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Repetitive Transcranial Magnetic Stimulation (rTMS)', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'CHU de Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}