Spinal Cord Neuromodulation for Spinal Cord Injury
Phase 1
Active, not recruiting
- Conditions
- TetraparesisTetraplegiaCervical Spinal Cord Injury
- Interventions
- Device: Epidural Stimulation
- Registration Number
- NCT02313194
- Lead Sponsor
- University of California, Los Angeles
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
- 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 Criteria
None as long as inclusion criteria are met.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Stimulation Epidural Stimulation Determine if epidural stimulation can improve motor function. Stimulation Buspirone Determine if epidural stimulation can improve motor function.
- Primary Outcome Measures
Name Time Method Assessment of arm/hand function 24 months Formal motor testing
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UCLA
🇺🇸Los Angeles, California, United States