Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2025-12-26 @ 10:59 AM
Study NCT ID:
NCT04470206
Status:
UNKNOWN
Last Update Posted:
2023-02-28
First Post:
2020-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Spinal Cord Stimulation for Neuropathic Pain Relief : Efficacy Study Using the Specific NPSI Questionnaire (NPSI)
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-12-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-27', 'studyFirstSubmitDate': '2020-07-08', 'studyFirstSubmitQcDate': '2020-07-13', 'lastUpdatePostDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of spinal cord stimulation on the various symptoms of neuropathic pain using the Neuropathic Pain Symptom Inventory (NPSI), change is being assessed.', 'timeFrame': 'Day 0; Day 7 after surgery; 3 months, 6 months and 12 months after surgery', 'description': 'Neuropathic pain score obtained by the NPSI questionnaire'}], 'secondaryOutcomes': [{'measure': 'Efficacy of spinal cord stimulation on the psychological level (anxiety and depression)', 'timeFrame': 'Day 0 and 12 months after surgery', 'description': 'Anxiety and depression score assessed by Hospital Anxiety and Depression (HAD) questionnaire'}, {'measure': 'Efficacy of spinal cord stimulation on quality of life.', 'timeFrame': 'Day 0 and 12 months after surgery', 'description': 'Quality of life score assessed by EQ-5D questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neuropathic pain', 'NPSI', 'Spinal Cord Stimulation'], 'conditions': ['Neuropathic Pain']}, 'descriptionModule': {'briefSummary': 'Several studies have shown the efficacy of spinal cord stimulation in reducing the intensity of neuropathic pain. This efficacy is defined as obtaining relief of at least 50% of the preoperative pain intensity assessed by the visual analog scale or the digital pain scale. No study has evaluated the efficacy of stimulation specifically on the different components of neuropathic pain, only an overall improvement in pain has been described.\n\nA specific questionnaire for neuropathic pain has been extensively validated in neuropathic pain: the Neuropathic Pain Symptom Inventory (NPSI).\n\nThanks to the multidimensional structure of this questionnaire, investigators propose to evaluate separately and in a much more specific way the efficacy of spinal cord stimulation in the short and long term on the different components of neuropathic pain and to define responders subgroups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with neuropathic pain following surgery or in the context of a complex regional pain syndrome and requiring spinal cord stimulation in the neurosurgery department of Foch Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* With neuropathic pain:\n\n * confirmed (DN4 score\\> 4/10)\n * going back to one year at least\n * refractory to well-conducted medical treatments\n* Requiring spinal cord stimulation: the indication is validated by the multidisciplinary meeting (RCP Neuromodulation / Pain at Foch Hospital)\n* Having given his non-opposition\n\nExclusion Criteria:\n\n* Patient with sepsis\n* Having no well-conducted prior medical treatment\n* With uncontrolled psychiatric disorders (active psychosis, suicidal disorders, severe depression)\n* with somatoform disorders\n* addicted to alcohol or drugs or withdrawal syndrome\n* Deprived of liberty or under guardianship.'}, 'identificationModule': {'nctId': 'NCT04470206', 'acronym': 'NPSI', 'briefTitle': 'Spinal Cord Stimulation for Neuropathic Pain Relief : Efficacy Study Using the Specific NPSI Questionnaire (NPSI)', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Foch'}, 'officialTitle': 'Spinal Cord Stimulation for Neuropathic Pain Relief : Efficacy Study Using the Specific NPSI Questionnaire', 'orgStudyIdInfo': {'id': '2020_0080'}}, 'contactsLocationsModule': {'locations': [{'zip': '92500', 'city': 'Suresnes', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Naoufel Ouerchefani, MD', 'role': 'CONTACT', 'email': 'n.ouerchefani@hopital-foch.com', 'phone': '0033 1 46 25 35 33'}], 'facility': 'Hôpital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}], 'centralContacts': [{'name': 'Naoufel Ouerchefani, MD', 'role': 'CONTACT', 'email': 'n.ouerchefani@hopital-foch.com', 'phone': '01 46 25 35 33', 'phoneExt': '0033'}], 'overallOfficials': [{'name': 'Naoufel Ouerchefani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Foch Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Foch', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}