Epidural Stimulation After Neurologic Damage

Description

This study will evaluate a method to optimize parameter settings in epidural spinal cord stimulation used to recover lower extremity volitional movement. The study will also characterize improvement in autonomic function (such as blood pressure control) and other functions related to spinal cord injury.

Conditions

Spinal Cord Injuries, Paraplegia, Complete

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Study Overview

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Study Details

Study overview

This study will evaluate a method to optimize parameter settings in epidural spinal cord stimulation used to recover lower extremity volitional movement. The study will also characterize improvement in autonomic function (such as blood pressure control) and other functions related to spinal cord injury.

Epidural Stimulation for Spinal Cord Injury

Epidural Stimulation After Neurologic Damage

Condition
Spinal Cord Injuries
Intervention / Treatment

-

Contacts and Locations

Minneapolis

Hennepin County Medical Center, Minneapolis, Minnesota, United States, 55415

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

22 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Minnesota,

David Darrow, MD, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

2028-01