Spinal Cord Neuromodulation for Spinal Cord Injury

• Status: Active, not recruiting
• Trial end date: 2024-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles
• Treatments: Buspirone

Criteria

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.