Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-28 @ 9:56 AM
Study NCT ID:
NCT04598035
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-07
First Post:
2020-10-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidural Spinal Cord Stimulation for Hypertension in Patients With Neuropathic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003955', 'term': 'Diagnostic Tests, Routine'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}, 'targetDuration': '2 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2020-10-07', 'studyFirstSubmitQcDate': '2020-10-16', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline Blood Pressure Measurement to 1 week post-op', 'timeFrame': 'Baseline and 1 week post-op', 'description': 'Measurements of blood pressure via arm cuff and finger cuff'}, {'measure': 'Change from Baseline Blood Pressure Measurement to 4 week post-op', 'timeFrame': 'Baseline and 4 week post-op', 'description': 'Measurements of blood pressure via arm cuff and finger cuff'}, {'measure': 'Change from Baseline Blood Pressure Measurement to 8 week post-op', 'timeFrame': 'Baseline and 8 week post-op', 'description': 'Measurements of blood pressure via arm cuff and finger cuff'}, {'measure': 'Change from Baseline PainDETECT Questionnaire to 1 week post-op', 'timeFrame': 'Baseline and 1 week post-op.', 'description': 'A battery of questionnaires is intended to understand key aspects of pain, mood, and function as quickly and efficiently as possible. The focus of these measures is on obtaining an accurate assessment of pain, while also asking about physical function, anxiety, and other associated somatic disturbances. These questionnaires will be taken prior to SCS implant (Baseline) and after SCS implant (1 week post-op, 4 weeks post-op, and 8 weeks post-op ) to assess and compare.\n\nNeuropathic Pain Descriptors: The Pain DETECT is a 9-item measure of sensory descriptors and spatial and temporal characteristics that has demonstrated utility in identifying central neuropathic pain.'}, {'measure': 'Change from Baseline PainDETECT Questionnaire to 4 week post-op', 'timeFrame': 'Baseline and 4 week post-op.', 'description': 'A battery of questionnaires is intended to understand key aspects of pain, mood, and function as quickly and efficiently as possible. The focus of these measures is on obtaining an accurate assessment of pain, while also asking about physical function, anxiety, and other associated somatic disturbances. These questionnaires will be taken prior to SCS implant (Baseline) and after SCS implant (1 week post-op, 4 weeks post-op, and 8 weeks post-op ) to assess and compare.\n\nNeuropathic Pain Descriptors: The Pain DETECT is a 9-item measure of sensory descriptors and spatial and temporal characteristics that has demonstrated utility in identifying central neuropathic pain.'}, {'measure': 'Change from Baseline PainDETECT Questionnaire to 8 week post-op', 'timeFrame': 'Baseline and 8 week post-op.', 'description': 'A battery of questionnaires is intended to understand key aspects of pain, mood, and function as quickly and efficiently as possible. The focus of these measures is on obtaining an accurate assessment of pain, while also asking about physical function, anxiety, and other associated somatic disturbances. These questionnaires will be taken prior to SCS implant (Baseline) and after SCS implant (1 week post-op, 4 weeks post-op, and 8 weeks post-op ) to assess and compare.\n\nNeuropathic Pain Descriptors: The Pain DETECT is a 9-item measure of sensory descriptors and spatial and temporal characteristics that has demonstrated utility in identifying central neuropathic pain.'}, {'measure': 'Baseline Laboratory Tests', 'timeFrame': 'Baseline', 'description': 'Serum creatinine, estimated glomerular filtration rate (eGFR), blood urea nitrogen (BUN), TNF-alpha, 8-Isoprostane'}, {'measure': '1 week post-op Laboratory Tests', 'timeFrame': '1 week post-op', 'description': 'Serum creatinine, estimated glomerular filtration rate (eGFR), blood urea nitrogen (BUN), TNF-alpha, 8-Isoprostane'}, {'measure': '4 week post-op Laboratory Tests', 'timeFrame': '4 week post-op', 'description': 'Serum creatinine, estimated glomerular filtration rate (eGFR), blood urea nitrogen (BUN), TNF-alpha, 8-Isoprostane'}, {'measure': '8 week post-op Laboratory Tests', 'timeFrame': '8 week post-op', 'description': 'Serum creatinine, estimated glomerular filtration rate (eGFR), blood urea nitrogen (BUN), TNF-alpha, 8-Isoprostane'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Pain', 'Hypertension', 'Implanted Stimulation Electrodes']}, 'descriptionModule': {'briefSummary': 'The purpose of the ESCAPE Study is to determine the extent to which epidural spinal cord stimulation (SCS) reduces arterial blood pressure (BP) in patients which chronic low back pain and hypertension. We also aim to determine the extent to which higher baseline BP (i.e., hypertension) predicts reductions in pain following SCS implant. This is an observational study of patients undergoing an implantation of a SCS device.', 'detailedDescription': 'The broad research goal of this study is to examine the extent to which arterial blood pressure (BP) and blood markers related to hypertension and kidney function are reduced in a prospective cohort of patients undergoing implantation of an epidural spinal cord stimulator (SCS) for the purpose of managing chronic pain in the lower back and/or limbs.\n\nSpecific aims:\n\n1. Examine the extent to which BP (primary variable), norepinephrine (marker of sympathetic nerve activity in the blood), and a vascular ultrasound scan are improved following the implant of a SCS device among patients with chronic pain and hypertension.\n2. Examine the extent to which markers of kidney function in the blood \\[serum creatinine, glomerular filtration rate (GFR), and blood urea nitrogen (BUN)\\] are reduced following the implant of a SCS device among patients with chronic pain and hypertension.\n3. Determine the extent to which BP predicts reductions in pain following the implant of a SCS device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Chronic low back pain (complex regional pain syndrome, failed back surgery syndrome)', 'healthyVolunteers': False, 'eligibilityCriteria': '* Planning to have an epidural spinal cord stimulation device implanted at KUMC\n* Male or Female, age 30-89\n* Low back pain for more than 3 months\n* Willing to visit research lab\n* Willing to undergo a blood draw and blood pressure measures\n* Able to provide written informed consent'}, 'identificationModule': {'nctId': 'NCT04598035', 'acronym': 'ESCAPE', 'briefTitle': 'Epidural Spinal Cord Stimulation for Hypertension in Patients With Neuropathic Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Epidural Spinal Cord Stimulation for Hypertension in Patients With Neuropathic Pain', 'orgStudyIdInfo': {'id': '00145752'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Primary Group', 'description': 'Patients with chronic low back pain that candidates them for surgical implant of a SCS device, and received a permanent SCS device.', 'interventionNames': ['Diagnostic Test: Diagnostic Tests']}, {'label': 'Control Group', 'description': 'Patients with chronic low back pain that are candidates for a surgical implant of a SCS device and do not receive a permanent SCS device after trial leads are placed.', 'interventionNames': ['Diagnostic Test: Diagnostic Tests']}], 'interventions': [{'name': 'Diagnostic Tests', 'type': 'DIAGNOSTIC_TEST', 'description': '1. Blood and Urine laboratory tests\n2. ECG and blood pressure for cardiovascular measurements\n3. Self-report questionnaires about pain', 'armGroupLabels': ['Control Group', 'Primary Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66205', 'city': 'Fairway', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Clinical and Translational Science Unit (CTSU)', 'geoPoint': {'lat': 39.02223, 'lon': -94.6319}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'The Marc A. Asher Comprehensive Spine Center at the Kansas University Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Seth W Holwerda, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'IPD may be available upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Seth Holwerda PhD', 'investigatorAffiliation': 'University of Kansas Medical Center'}}}}