Epidural stimulation to improve movement and autonomic function after spinal cord injury

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 use of epidural spinal cord stimulation (SCS) to enhance voluntary movement and autonomic function in individuals with complete spinal cord injuries. It aims to optimize stimulation parameters through a clinical decision support system, exploring the effects on cardiovascular health, urinary function, psychiatric outcomes, and overall quality of life. The research builds on existing knowledge of SCS for pain management, applying it to a new population with significant variability in outcomes. By establishing the disinhibitory effects of SCS, the study seeks to provide a comprehensive understanding of its benefits for patients with chronic spinal cord injury.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

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

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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.