Long-term effects of epidural stimulation for spinal cord injury recovery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the long-term effects of chronic spinal cord stimulation on restoring voluntary movement in patients with chronic spinal cord injuries. Participants will be enrolled for a decade and will attend assessments biannually in Minneapolis, where they will undergo various programming settings of their spinal cord stimulators. The goal is to determine the efficacy of epidural stimulation in improving motor function over time.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hennepin County Medical Center
  Minneapolis, Minnesota, United States Recruiting

Study contacts

• Principal investigator: David Darrow, MD — University of Minnesota
• Study coordinator: Study Coordinator
• Email: estand@umn.edu
• Phone: 612-873-9113

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Targeted spinal cord stimulation to reduce spasticity in spinal cord injury

  This study tests whether an implanted epidural stimulator can help reduce severe spasticity and improve voluntary movement in adults with spinal cord injury.

  Recruiting Kessler Foundation · West Orange, New Jersey · NCT07890558

• Spinal cord stimulation for bladder and bowel problems after spinal cord injury

  This project will test spinal cord stimulation to see if it helps people with bladder and bowel problems after a spinal cord injury.

  Recruiting Beijing Tsinghua Chang Gung Hospital · Beijing · NCT07511244

• Home-based passive heat therapy to improve cardiovascular health after spinal cord injury

  This program will test whether regular passive heat sessions at home can improve blood vessel and heart health in adults with chronic spinal cord injury.

  Recruiting The University of Texas Health Science Center at San Antonio · San Antonio, Texas · NCT07317843

• ARC-IM therapy to help restore walking after spinal cord injury

  This study will try ARC-IM Therapy (epidural electrical stimulation) in adults with subacute or chronic traumatic spinal cord injury to see if it helps improve walking and other ambulatory functions.

  Recruiting Ecole Polytechnique Fédérale de Lausanne · Nottwil, Canton of Lucerne and 1 other locations · NCT07234903

• Near-infrared imaging to see how motor imagery affects recovery after spinal cord injury

  This trial will test whether a motor-imagery brain-computer interface (MI-BCI) can help adults with recent cervical-to-thoracic spinal cord injuries improve motor function and change brain activity measured by fNIRS and EEG.

  Recruiting Shengjing Hospital · Shenyang, Liaoning · NCT07106060

• How different meals affect metabolism and heat production after high spinal cord injury

  This study will see if different meal sizes change heart and metabolic responses in men with and without high spinal cord injury.

  Recruiting University of Miami · Miami, Florida · NCT07103993

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.