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OpenTrials
Active, Not Recruiting

NCT Number: NCT02313194

Spinal Cord Neuromodulation for Spinal Cord Injury

This study is designed to assess the strategy of using spinal cord stimulation to improve the ability to move in spinal cord injured humans.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cervical Spinal Cord Injury Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Quadriplegia Signs and Symptoms Tetraparesis Tetraplegia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

UCLA

Los Angeles, California, 90095, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Epidural stimulation

Device

Determine if epidural stimulation can improve motor function

Buspirone

Drug

Determine if the pharmacological agent in combination with the stimulator can improve motor function.

Primary outcomes

  1. Assessment of arm/hand function

    Time frame: 24 months

    Formal motor testing

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

Enabling Forelimb Function With Agonist Drug and Epidural Stimulation in SCI

Important dates

Study start
2013
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2014
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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