Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Daniel C Lu, MD PhD (ucla)

Description

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.

Official Title

Enabling Forelimb Function With Agonist Drug and Epidural Stimulation in SCI

Details

An epidural stimulation device will be tested to determine if motor function can be improved.

Keywords

Cervical Spinal Cord Injury Tetraparesis Tetraplegia Spinal Cord Injuries Quadriplegia Buspirone Epidural Stimulation Stimulation

Eligibility

You can join if…

Open to people ages 18 years and up

  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

You CAN'T join if...

None as long as inclusion criteria are met.

Location

  • UCLA
    Los Angeles California 90095 United States

Lead Scientist at University of California Health

  • Daniel C Lu, MD PhD (ucla)
    Professor, Neurosurgery. Authored (or co-authored) 85 research publications.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT02313194
Phase
Phase 1/2
Study Type
Interventional
Last Updated