Status:
ACTIVE_NOT_RECRUITING
Spinal Cord Neuromodulation for Spinal Cord Injury
Lead Sponsor:
University of California, Los Angeles
Conditions:
Cervical Spinal Cord Injury
Tetraparesis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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.
Eligibility Criteria
Inclusion
- Stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate hand/arm movement
- No severe cardiopulmonary diseases such as severe bradycardia, severe autonomic dysreflexia, and/or Chronic Obstructive Pulmonary Disease.
- No painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or infection that might interfere with upper extremity training
- No clinically significant depression or ongoing drug abuse
- No current anti-spasticity medication regimen
- Non-progressive SCI above C5
- Must not have received botox injections in the prior six months
- Be unable to grip or move independently
- Be at least one-year post injury
- Must be at least 18 years of age
- Segmental reflexes remain functional below the lesion
- Female subjects of child-bearing potential must not be pregnant and must be using a medically acceptable method of contraception
- No current implant(s) of neurostimulators, cardiac pacemakers, defibrillators, shunts, stents, or aneurysm clips, and must have no future exposure to diathermy following implantation
- No coagulopathy, cardiac risk factors, or other significant medical risk factors for surgery
- Must not be involved in another clinical trial
- Must not have disorders or conditions that would require MRI monitoring
Exclusion
- None as long as inclusion criteria are met.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02313194
Start Date
July 1 2013
End Date
December 30 2026
Last Update
March 13 2025
Active Locations (1)
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1
UCLA
Los Angeles, California, United States, 90095