Spinal Cord Neuromodulation for Spinal Cord Injury
Primary Purpose
Cervical Spinal Cord Injury, Tetraparesis, Tetraplegia
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Epidural Stimulation
Buspirone
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Spinal Cord Injury
Eligibility Criteria
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.
Sites / Locations
- UCLA
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stimulation
Arm Description
Determine if epidural stimulation can improve motor function.
Outcomes
Primary Outcome Measures
Assessment of arm/hand function
Formal motor testing
Secondary Outcome Measures
Full Information
NCT ID
NCT02313194
First Posted
December 5, 2014
Last Updated
May 17, 2023
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT02313194
Brief Title
Spinal Cord Neuromodulation for Spinal Cord Injury
Official Title
Enabling Forelimb Function With Agonist Drug and Epidural Stimulation in SCI
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Spinal Cord Injury, Tetraparesis, Tetraplegia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stimulation
Arm Type
Experimental
Arm Description
Determine if epidural stimulation can improve motor function.
Intervention Type
Device
Intervention Name(s)
Epidural Stimulation
Intervention Description
Determine if epidural stimulation can improve motor function
Intervention Type
Drug
Intervention Name(s)
Buspirone
Intervention Description
Determine if the pharmacological agent in combination with the stimulator can improve motor function.
Primary Outcome Measure Information:
Title
Assessment of arm/hand function
Description
Formal motor testing
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel C Lu, MD PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Spinal Cord Neuromodulation for Spinal Cord Injury
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