Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-01-28 @ 12:14 AM
Study NCT ID:
NCT02313194
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-13
First Post:
2014-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spinal Cord Neuromodulation for Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011782', 'term': 'Quadriplegia'}], 'ancestors': [{'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002065', 'term': 'Buspirone'}], 'ancestors': [{'id': 'D013141', 'term': 'Spiro Compounds'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2014-12-05', 'studyFirstSubmitQcDate': '2014-12-08', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of arm/hand function', 'timeFrame': '24 months', 'description': 'Formal motor testing'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cervical Spinal Cord Injury', 'Tetraparesis', 'Tetraplegia']}, 'descriptionModule': {'briefSummary': 'This study is designed to assess the strategy of using spinal cord stimulation to improve the ability to move in spinal cord injured humans.', 'detailedDescription': 'An epidural stimulation device will be tested to determine if motor function can be improved.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate hand/arm movement\n2. No severe cardiopulmonary diseases such as severe bradycardia, severe autonomic dysreflexia, and/or Chronic Obstructive Pulmonary Disease.\n3. No painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or infection that might interfere with upper extremity training\n4. No clinically significant depression or ongoing drug abuse\n5. No current anti-spasticity medication regimen\n6. Non-progressive SCI above C5\n7. Must not have received botox injections in the prior six months\n8. Be unable to grip or move independently\n9. Be at least one-year post injury\n10. Must be at least 18 years of age\n11. Segmental reflexes remain functional below the lesion\n12. Female subjects of child-bearing potential must not be pregnant and must be using a medically acceptable method of contraception\n13. No current implant(s) of neurostimulators, cardiac pacemakers, defibrillators, shunts, stents, or aneurysm clips, and must have no future exposure to diathermy following implantation\n14. No coagulopathy, cardiac risk factors, or other significant medical risk factors for surgery\n15. Must not be involved in another clinical trial\n16. Must not have disorders or conditions that would require MRI monitoring\n\nExclusion Criteria:\n\nNone as long as inclusion criteria are met.'}, 'identificationModule': {'nctId': 'NCT02313194', 'briefTitle': 'Spinal Cord Neuromodulation for Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Enabling Forelimb Function with Agonist Drug and Epidural Stimulation in SCI', 'orgStudyIdInfo': {'id': '12-001416'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stimulation', 'description': 'Determine if epidural stimulation can improve motor function.', 'interventionNames': ['Device: Epidural Stimulation', 'Drug: Buspirone']}], 'interventions': [{'name': 'Epidural Stimulation', 'type': 'DEVICE', 'description': 'Determine if epidural stimulation can improve motor function', 'armGroupLabels': ['Stimulation']}, {'name': 'Buspirone', 'type': 'DRUG', 'description': 'Determine if the pharmacological agent in combination with the stimulator can improve motor function.', 'armGroupLabels': ['Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Daniel C Lu, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Daniel Lu, MD, PhD', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}