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

April 10, 2024 updated by: University of Minnesota
This study will evaluate the long-term effect of chronic spinal cord stimulation to restore volitional movement for patients with chronic spinal cord injuries.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

  • Name: Study Coordinator
  • Phone Number: 612-873-9113
  • Email: estand@umn.edu

Study Contact Backup

  • Name: Study Coordinator
  • Phone Number: 612-873-9113
  • Email: rnl@umn.edu

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Recruiting
        • Hennepin County Medical Center
        • Contact:
        • Contact:

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

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

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: Volitional EMG power
Assessing the change in volitional EMG power during the Brain Motor Control Assement (BMCA) between nonstimulation baseline and stimulation.
Device: Epidural Spinal Cord Stimulation
Stimulation of the spinal cord from the epidural space.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Volitional electromyography (EMG) power
Time Frame: 10 years
The measurement of volitional change using EMG during the Brain Motor Control assessment between nonstimulation baseline and stimulation
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prediction of power preferences
Time Frame: 10 years
Prediction of power of preference models built based on evaluations of stimulation settings.
10 years

Collaborators and Investigators

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

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: David Darrow, MD, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Actual)

March 1, 2023

Primary Completion (Estimated)

April 1, 2033

Study Completion (Estimated)

April 1, 2034

Study Registration Dates

First Submitted

January 4, 2023

First Submitted That Met QC Criteria

January 20, 2023

First Posted (Actual)

January 30, 2023

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-FY2022-365

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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