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Spinal Cord Neuromodulation for SCI

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ClinicalTrials.gov Identifier: NCT02313194
Recruitment Status : Unknown
Verified January 2016 by Daniel Lu MD PhD, University of California, Los Angeles.
Recruitment status was:  Recruiting
First Posted : December 9, 2014
Last Update Posted : January 27, 2016
Sponsor:
Information provided by (Responsible Party):
Daniel Lu MD PhD, 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.

Condition or disease Intervention/treatment Phase
Cervical Spinal Cord Injury Tetraparesis Tetraplegia Device: Epidural Stimulation Phase 1 Phase 2

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enabling Forelimb Function With Agonist Drug and Epidural Stimulation in SCI
Study Start Date : July 2013
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Arm Intervention/treatment
Experimental: Stimulation
Determine if epidural stimulation can improve motor function.
Device: Epidural Stimulation
Determine if epidural stimulation can improve motor function




Primary Outcome Measures :
  1. Assessment of arm/hand function [ Time Frame: 24 months ]
    Formal motor testing



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02313194


Contacts
Contact: Daniel C Lu, MD PhD 310-825-4321 dclu@mednet.ucla.edu

Locations
United States, California
UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Daniel C Lu, MD PhD    310-825-4321    dclu@mednet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Daniel C Lu, MD PhD University of California, Los Angeles

Responsible Party: Daniel Lu MD PhD, Associate Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02313194     History of Changes
Other Study ID Numbers: 12-001416
First Posted: December 9, 2014    Key Record Dates
Last Update Posted: January 27, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Spinal Cord Injuries
Quadriplegia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Paralysis
Neurologic Manifestations
Signs and Symptoms