Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2026-03-03 @ 2:52 AM
Study NCT ID:
NCT02615418
Status:
UNKNOWN
Last Update Posted:
2015-11-30
First Post:
2015-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non Invasive Brain Stimulation Treatment for CLBP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010808', 'term': 'Physical Examination'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-11-26', 'studyFirstSubmitDate': '2015-11-23', 'studyFirstSubmitQcDate': '2015-11-24', 'lastUpdatePostDateStruct': {'date': '2015-11-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in CLBP on a 0-10 Numerical Pain Rating Scale (NPRS)', 'timeFrame': 'Baseline to week 6 .'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Sleep Quality (0-10 Numerical Rating Scale Scores)', 'timeFrame': 'Baseline to 6 weeks'}, {'measure': 'Change CLBP quality of life -Roland-Morris questionnaire', 'timeFrame': 'Baseline to 6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Low Back Pain (CLBP)']}, 'descriptionModule': {'briefSummary': 'This trial is designed to preliminary evaluate the efficacy and safety of NIBS system for treatment of chronic low back pain (CLBP) (over 6 months). The trial is of a double blind sham controlled partial crossover design and will involve 2 weekly treatments and evaluations for 6 weeks, with 6 weeks follow-up. The goal of the study is to 1. Asses the CLBP change immediate and long term effect for the trial duration and follow-up. 2. Asses quality of life improvement as measure by sleep quality and questioners. 3. Asses long term neuronal changes or lack thereof in treated and untreated subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 to 80\n* CLBP as defined by the European guidelines.\n* low back pain first week average NPRS\\>4.\n\nExclusion Criteria:\n\n1. Acute low back pain (duration of less than 6 months) first week average NPRS\\> 4\n2. Neurological illness causing structural brain damage (e.g. Stroke, TIA)\n3. Psychiatric disease other than mood disorders\n4. Current chronic use of medications with pro-epileptic properties\n5. Known alcohol dependency\n6. Use of alcohol within the previous 24 hours\n7. History of loss of consciousness\n8. Epilepsy or epilepsy in a first degree relative\n9. Medical implants\n10. Pregnancy\n11. Illicit drug use or within the previous month'}, 'identificationModule': {'nctId': 'NCT02615418', 'acronym': 'NIBSTCLBP', 'briefTitle': 'Non Invasive Brain Stimulation Treatment for CLBP', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIBS NeuroScience Technologies'}, 'officialTitle': 'A Novel Non Invasive Brain Stimulation,tDCS Based Treatment for Chronic Low Back Pain (CLBP)-Sourasky Medical Center-Tel Aviv', 'orgStudyIdInfo': {'id': 'NIBS-Sour-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fully active treatement', 'interventionNames': ['Device: NIBS system for evaluation and treatment utilizing non invasive brain stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'partially active', 'description': 'first 2.5 weeks will receive sham treatment followed by active', 'interventionNames': ['Device: NIBS system for evaluation and treatment utilizing non invasive brain stimulation']}], 'interventions': [{'name': 'NIBS system for evaluation and treatment utilizing non invasive brain stimulation', 'type': 'DEVICE', 'armGroupLabels': ['Fully active treatement', 'partially active']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Iftach Dolev, PhD', 'role': 'CONTACT', 'email': 'iftach@nibs.co.il'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NIBS NeuroScience Technologies', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}