Enabling Forelimb Function With Agonist Drug and Epidural Stimulation in SCI

12-001416

This study is designed to assess the strategy of using spinal cord stimulation to improve the ability to move in spinal cord injured humans.

2013-07-01

2024-12-30

2024-12-30

Active (not recruiting)

Early phase I

12

Inclusion Criteria: 1. Stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate hand/arm movement 2. No severe cardiopulmonary diseases such as severe bradycardia, severe autonomic dysreflexia, and/or Chronic Obstructive Pulmonary Disease. 3. No painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or infection that might interfere with upper extremity training 4. No clinically significant depression or ongoing drug abuse 5. No current anti-spasticity medication regimen 6. Non-progressive SCI above C5 7. Must not have received botox injections in the prior six months 8. Be unable to grip or move independently 9. Be at least one-year post injury 10. Must be at least 18 years of age 11. Segmental reflexes remain functional below the lesion 12. Female subjects of child-bearing potential must not be pregnant and must be using a medically acceptable method of contraception 13. No current implant(s) of neurostimulators, cardiac pacemakers, defibrillators, shunts, stents, or aneurysm clips, and must have no future exposure to diathermy following implantation 14. No coagulopathy, cardiac risk factors, or other significant medical risk factors for surgery 15. Must not be involved in another clinical trial 16. Must not have disorders or conditions that would require MRI monitoring Exclusion Criteria: None as long as inclusion criteria are met.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 12, 'type': 'ESTIMATED'}}

2023-05-19