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Epidural Stimulation After Neurologic Damage: Long-Term Outcomes (LTO)

Primary Purpose

SCI - Spinal Cord Injury

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Epidural Spinal Cord Stimulation
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SCI - Spinal Cord Injury focused on measuring spinal cord stimulation, epidural stimulation

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 22 years of age or older Able to undergo the informed consent process Stable spinal cord injury International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) neurologic level of injury below C5 No ventilator dependency within the last year American Spinal Injury Association (AISA) imparement scale"A" or "B" in the absence of spinal cord stimulation Medically stable in the judgment of the Principal investigator Greater than 1 year since initial injury and at least 6 months from any required spinal instrumentation and 2 months from spinal cord stimulator surgery Has an existing and functional implanted spinal cord stimulator system that is FDA approved and can be corroborated by hospital documentation Spinal imaging of the stimulator system Exclusion Criteria: Current and anticipated need for opioid pain medications or pain that would prevent full participation in the rehabilitation program in the judgment of the principal investigator Use of botulinum toxin (Botox) injections in the previous six months Clinically significant mental illness in the judgment of the principal investigator Other conditions or medications that would make the subject unable to participate in testing/rehabilitation in the judgment of the principal investigator Nonfunctional spinal cord stimulator or near end-of-life, determined by the PI Current Pregnancy Current pain relief from the spinal cord stimulator if the indication for implantation was for management of chronic pain.

Sites / Locations

  • Hennepin County Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Volitional EMG power

Arm Description

Assessing the change in volitional EMG power during the Brain Motor Control Assement (BMCA) between nonstimulation baseline and stimulation.

Outcomes

Primary Outcome Measures

Change in Volitional electromyography (EMG) power
The measurement of volitional change using EMG during the Brain Motor Control assessment between nonstimulation baseline and stimulation

Secondary Outcome Measures

Prediction of power preferences
Prediction of power of preference models built based on evaluations of stimulation settings.

Full Information

First Posted
January 4, 2023
Last Updated
April 6, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT05705453
Brief Title
Epidural Stimulation After Neurologic Damage: Long-Term Outcomes
Acronym
LTO
Official Title
Epidural Stimulation After Neurologic Damage: Long-Term Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
April 1, 2033 (Anticipated)
Study Completion Date
April 1, 2034 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the long-term effect of chronic spinal cord stimulation to restore volitional movement for patients with chronic spinal cord injuries.
Detailed Description
Participants will be enrolled in this study for the duration of 10 years. They will need to come to Minneapolis twice a year for the Brain Motor Control Assessment and will be given different settings within their Spinal Cord Stimulator (SCS) programing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SCI - Spinal Cord Injury
Keywords
spinal cord stimulation, epidural stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Volitional EMG power
Arm Type
Experimental
Arm Description
Assessing the change in volitional EMG power during the Brain Motor Control Assement (BMCA) between nonstimulation baseline and stimulation.
Intervention Type
Device
Intervention Name(s)
Epidural Spinal Cord Stimulation
Intervention Description
Stimulation of the spinal cord from the epidural space.
Primary Outcome Measure Information:
Title
Change in Volitional electromyography (EMG) power
Description
The measurement of volitional change using EMG during the Brain Motor Control assessment between nonstimulation baseline and stimulation
Time Frame
10 years
Secondary Outcome Measure Information:
Title
Prediction of power preferences
Description
Prediction of power of preference models built based on evaluations of stimulation settings.
Time Frame
10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 22 years of age or older Able to undergo the informed consent process Stable spinal cord injury International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) neurologic level of injury below C5 No ventilator dependency within the last year American Spinal Injury Association (AISA) imparement scale"A" or "B" in the absence of spinal cord stimulation Medically stable in the judgment of the Principal investigator Greater than 1 year since initial injury and at least 6 months from any required spinal instrumentation and 2 months from spinal cord stimulator surgery Has an existing and functional implanted spinal cord stimulator system that is FDA approved and can be corroborated by hospital documentation Spinal imaging of the stimulator system Exclusion Criteria: Current and anticipated need for opioid pain medications or pain that would prevent full participation in the rehabilitation program in the judgment of the principal investigator Use of botulinum toxin (Botox) injections in the previous six months Clinically significant mental illness in the judgment of the principal investigator Other conditions or medications that would make the subject unable to participate in testing/rehabilitation in the judgment of the principal investigator Nonfunctional spinal cord stimulator or near end-of-life, determined by the PI Current Pregnancy Current pain relief from the spinal cord stimulator if the indication for implantation was for management of chronic pain.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Coordinator
Phone
612-873-9113
Email
estand@umn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Study Coordinator
Phone
612-873-9113
Email
rnl@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Darrow, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tara Nash, FNP
Phone
612-873-9113
Email
estand@umn.edu
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Email
rnl@umn.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://estand.org
Description
Clinical Trial Website

Learn more about this trial

Epidural Stimulation After Neurologic Damage: Long-Term Outcomes

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