Spinal Cord Neuromodulation for Spinal Cord Injury

May 17, 2023 updated by: Daniel Lu, MD, PhD, University of California, Los Angeles

Enabling Forelimb Function With Agonist Drug and Epidural Stimulation in SCI

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stimulation
Determine if epidural stimulation can improve motor function.
Device: Epidural Stimulation
Determine if epidural stimulation can improve motor function
Drug: Buspirone
Determine if the pharmacological agent in combination with the stimulator can improve motor function.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of arm/hand function
Time Frame: 24 months
Formal motor testing
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Investigators

  • Principal Investigator: Daniel C Lu, MD PhD, University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

December 30, 2024

Study Completion (Anticipated)

December 30, 2024

Study Registration Dates

First Submitted

December 5, 2014

First Submitted That Met QC Criteria

December 8, 2014

First Posted (Estimate)

December 9, 2014

Study Record Updates

Last Update Posted (Actual)

May 19, 2023

Last Update Submitted That Met QC Criteria

May 17, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-001416

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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