Cervical Spinal Cord Injury, Tetraparesis, Tetraplegia
Conditions
Brief summary
This study is designed to assess the strategy of using spinal cord stimulation to improve the ability to move in spinal cord injured humans.
Detailed description
An epidural stimulation device will be tested to determine if motor function can be improved.
Interventions
DEVICEEpidural Stimulation
Determine if epidural stimulation can improve motor function
DRUGBuspirone
Determine if the pharmacological agent in combination with the stimulator can improve motor function.
Sponsors
University of California, Los Angeles
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of arm/hand function | 24 months | Formal motor testing |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDaniel C Lu, MD PhD
University of California, Los Angeles
Outcome results
None listed