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Spinal Cord Neuromodulation for Spinal Cord Injury

Phase 1
Active, not recruiting
Conditions
Tetraparesis
Tetraplegia
Cervical 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
  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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
StimulationEpidural StimulationDetermine if epidural stimulation can improve motor function.
StimulationBuspironeDetermine if epidural stimulation can improve motor function.
Primary Outcome Measures
NameTimeMethod
Assessment of arm/hand function24 months

Formal motor testing

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

UCLA

🇺🇸

Los Angeles, California, United States

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