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Epidural Spinal Cord Stimulation for Spinal Cord Injury

This study is looking at how to best use Epidural Spinal Cord Stimulation (a device that sends electrical signals to the spinal cord) to help people with complete paraplegia (paralysis of the lower body) regain movement in their legs. Researchers are also studying if this treatment can improve other body functions like blood pressure control. You might be able to join if you are 22 or older, have stable motor-complete paraplegia from a spinal cord injury between C6 and T10, and it's been over a year since your injury. The main goal is to see changes in your ability to move your legs voluntarily over 15 months. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 100 participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for changes in volitional response magnitude over 15 months.

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NCT03026816

Epidural Stimulation After Neurologic Damage

Recruiting
NAAges 22+InterventionalTreatment
University of Minnesota
~100 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 Response Index Magnitude
Measured over Months: 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15

Conditions

Spinal Cord Injuries
Paraplegia, Complete

Explore related trials

ParaplegiaSpinal Cord Injury

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • David Darrow, MD · PRINCIPAL_INVESTIGATOR · University of Minnesota

Who to contact

Study Coordinator
[email protected]
612-873-9113
Email the study team

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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/assent process
Stable, motor-complete paraplegia
Discrete spinal cord injury between C6 and T10
ASIA A or B Spinal Cord Injury Classification
Medically stable in the judgement of the principal investigator
Intact segmental reflexes below the lesion of injury
Greater than 1 year since initial injury and at least 6 months from any required spinal instrumentation
Willing to attend all scheduled appointments

Exclusion

Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery (e.g. cardiopulmonary issues)
Inability to withhold antiplatelet/anticoagulation agents perioperatively
Significant dysautonomia that would prohibit rehabilitation or assisted standing or any history of CVA or MI associated with autonomic dysreflexia. A single tilt table test with syncope, presyncope, or SBP \< 50 or \>200.
Other conditions that would make the subject unable to participate in testing/rehabilitation in the judgement of the principal investigator
Current and anticipated need for opioid pain medications or pain that would prevent full participation in the rehabilitation program in the judgement of the principal investigator
Clinically significant mental illness in the judgement of the principal investigator
Botulinum toxin injections in the previous 6 months
Volitional movements present during EMG testing in bilateral lower extremities
Unhealed spinal fracture
Presence of significant contracture
Presence of pressure ulcers
Recurrent urinary tract infection refractory to antibiotics
Current Pregnancy

What this trial measures

  • Change in Volitional Response Index MagnitudeMonths: 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15

    Brain Motor Control Assessment Volitional Response Index Magnitude