Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-01-01 @ 10:36 PM
Study NCT ID:
NCT06377969
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-22
First Post:
2024-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Evaluation of Effectiveness and Safety of Closed-Loop Spinal Cord Stimulation in Treating Patients With Chronic Pelvic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Pilot prospective single arm interventional study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-21', 'studyFirstSubmitDate': '2024-04-17', 'studyFirstSubmitQcDate': '2024-04-17', 'lastUpdatePostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain Intensity', 'timeFrame': 'Baseline, 3-month, 6-month and 12-month', 'description': 'Numerical Rating Scale (0-10; higher score is worse)'}], 'secondaryOutcomes': [{'measure': 'Change in Disability', 'timeFrame': 'Baseline, 3-month, 6-month and 12-month', 'description': 'Pain Disability Index'}, {'measure': 'Patient Global Impression Change', 'timeFrame': 'Baseline, 3-month, 6-month and 12-month', 'description': '7-point Likert Scale'}, {'measure': 'Change in Quality of Life', 'timeFrame': 'Baseline, 3-month, 6-month and 12-month', 'description': 'Short Form McGill Pain Questionnaire'}, {'measure': 'Change in Pain Catastrophizing Scale', 'timeFrame': 'Baseline, 3-month, 6-month and 12-month', 'description': '14-item questionnaire scoring 0-52 (higher score worse)'}, {'measure': 'Change in sleep quality', 'timeFrame': 'Baseline, 3-month, 6-month and 12-month', 'description': 'PROMIS (Patient Reported Outcomes Measure Information System) Sleep Disturbance (t-score and percentile)'}, {'measure': 'Change in Social Functioning', 'timeFrame': 'Baseline, 3-month, 6-month and 12-month', 'description': 'PROMIS Satisfaction with social roles and activities (t-score and percentile)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Pelvic Pain Syndrome']}, 'descriptionModule': {'briefSummary': 'Spinal cord stimulation (SCS) is an effective treatment for patients with chronic pelvic pain. The investigators will evaluate how safe and effective closed-loop spinal cord stimulation is in treating these patients; closed-loop spinal cord stimulation is a more novel method in delivering spinal cord stimulation that controls energy output of the device based on real-time feedback on how the device is stimulating the spinal cord.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe investigators will include all adult patients (18 or older) with pelvic pain more than 6 months that has not responded to conservative medical management\n\nExclusion Criteria:\n\n* Major untreated medical comorbidities (uncontrolled diabetes mellitus, severe obesity, uncontrolled cardiopulmonary disease, etc.)\n* Secondary causes of pelvic pain that can be treated with appropriate medical or surgical interventions\n* Major untreated psychological comorbidities\n* Anatomical challeneges to place spinal cord stimulator\n* Ongoing legal or disability claims'}, 'identificationModule': {'nctId': 'NCT06377969', 'briefTitle': 'Prospective Evaluation of Effectiveness and Safety of Closed-Loop Spinal Cord Stimulation in Treating Patients With Chronic Pelvic Pain', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Prospective Evaluation of Effectiveness and Safety of Closed-Loop Spinal Cord Stimulation in Treating Patients With Chronic Pelvic Pain', 'orgStudyIdInfo': {'id': '75269'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Treatment', 'description': 'Patient will go through trial of spinal cord stimulator. If trial results in \\>50% reduction in pain, they will receive implantable spinal cord stimulator', 'interventionNames': ['Device: ECAP (Evoked Compound Action Potential)-controlled Closed-Loop Spinal Cord Stimulation']}], 'interventions': [{'name': 'ECAP (Evoked Compound Action Potential)-controlled Closed-Loop Spinal Cord Stimulation', 'type': 'DEVICE', 'description': 'The patients will receive externalized epidural leads connected to external pulse generator for 5-14 days during trial phase. If the trial results in \\>50% reduction in pain, they will undergo a minor surgery to receive implantable spinal cord stimulator', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Vafi Salmasi, MD', 'role': 'CONTACT', 'email': 'vsalmasi@stanford.edu', 'phone': '6507250246'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Vafi Salmasi', 'investigatorAffiliation': 'Stanford University'}}}}