Epidural Spinal Cord Stimulation for Spinal Cord Injury

This study is looking at the long-term effects of Epidural Spinal Cord Stimulation (a device that stimulates the spinal cord) to help people with chronic spinal cord injuries regain movement. You might be able to join if you are 22 or older, have a stable spinal cord injury below C5 (a specific level in your neck), and don't need a ventilator. The study will measure success by looking at changes in your muscle activity (volitional electromyography or EMG power) over 10 years. The current status of this study is unclear, and it plans to enroll 50 participants.

Study design
This is an interventional study that plans to enroll 50 participants. The phase of the study is not specified.
What's involved
You would be in this study for 10 years. You would need to travel to Minneapolis twice a year for assessments and to have your spinal cord stimulator adjusted.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 10 years, with the primary outcome measured at the end of this period.

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NCT05705453

Epidural Stimulation After Neurologic Damage: Long-Term Outcomes

Recruiting
NAAges 22+InterventionalTreatment
University of Minnesota
~50 participants
Updated 2026-04-08 on ClinicalTrials.gov
What's tested:Epidural Spinal Cord Stimulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Volitional electromyography (EMG) power
Measured over 10 years
SCI - Spinal Cord Injury
1 sites across 1 states
Minnesota1
  • David Darrow, MD · PRINCIPAL_INVESTIGATOR · University of Minnesota

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.
  • Change in Volitional electromyography (EMG) power10 years

    The measurement of volitional change using EMG during the Brain Motor Control assessment between nonstimulation baseline and stimulation