RECRUITING

Epidural Stimulation After Neurologic Damage

Conditions

Spinal Cord Injuries Paraplegia, Complete epidural stimulation spinal cord stimulation autonomic dysfunction

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Epidural Stimulation for Spinal Cord Injury

Quick Facts

Study Start:2017-08-07

Study Completion:2028-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03026816

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.

Ages Eligible for Study:22 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Study Coordinator

CONTACT

612-873-9113

estand@umn.edu

David Darrow, MD MPH

CONTACT

612-217-4290

estand@umn.edu

Principal Investigator

David Darrow, MD

PRINCIPAL_INVESTIGATOR

University of Minnesota

Study Locations (Sites)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415

United States

Collaborators and Investigators

Sponsor: University of Minnesota

David Darrow, MD, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-08-07

Study Completion Date2028-01

Study Record Updates

Study Start Date2017-08-07

Study Completion Date2028-01

Terms related to this study

Keywords Provided by Researchers

epidural stimulation
spinal cord stimulation
autonomic dysfunction

Additional Relevant MeSH Terms

Spinal Cord Injuries
Paraplegia, Complete