COMPLETED

Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury

Conditions

Spinal Cord Injuries Paraplegia Tetraplegia Paralysis

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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

A study to compare electrophysiologic activity of epidural stimulation and dorsal root ganglion stimulation, as well as quantify changes in motor performance with both types of stimulation over the course of 10 rehabilitation sessions.

Official Title

Pilot Study of Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury

Quick Facts

Study Start:2021-09-24

Study Completion:2025-03-19

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04736849

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
* Spinal cord injury due to trauma located at or above the tenth thoracic vertebrae * American Spinal Injury Association grading scale of A, B, C, or D * Intact spinal reflexes below the level of SCI * SCI must have occurred at least 1 year prior to study enrollment * At least 22 years of age * If female, must be willing to use medically-acceptable method of contraception during study participation	* Currently a prison inmate, or awaiting trial, related to criminal activity * Pregnancy at the time of screening for trial enrollment * Active, untreated urinary tract infection * Unhealed decubitus ulcer * Unhealed skeletal fracture * Spinal abnormality that may impede percutaneous implantation of spinal electrodes * Untreated clinical diagnosis of psychiatric disorder * Joint contractures that impede typical range of motion * Non-MRI-compatible implanted medical devices * Other implanted stimulation devices (e.g. deep brain stimulator, cardiac pacemaker, diaphragmatic pacer, etc.) * Undergoing, or planning to undergo, diathermy treatment * Active participation in an interventional clinical trial * History of clinically-diagnosed cardiopulmonary disorder, such as severe orthostatic hypotension, which may impede participation in rehabilitation activities such as changes in body position such as supine-to-sit-to-stand activities, prolonged standing, or stepping * History of frequent and/or severe autonomic dysreflexia * History of seizure disorder * Any illness or condition which, based on the research team's assessment, will compromise with the patient's ability to comply with the protocol, patient safety, or the validity of the data collected during this study

Inclusion Criteria

Exclusion Criteria

* Spinal cord injury due to trauma located at or above the tenth thoracic vertebrae
* American Spinal Injury Association grading scale of A, B, C, or D
* Intact spinal reflexes below the level of SCI
* SCI must have occurred at least 1 year prior to study enrollment
* At least 22 years of age
* If female, must be willing to use medically-acceptable method of contraception during study participation

* Currently a prison inmate, or awaiting trial, related to criminal activity
* Pregnancy at the time of screening for trial enrollment
* Active, untreated urinary tract infection
* Unhealed decubitus ulcer
* Unhealed skeletal fracture
* Spinal abnormality that may impede percutaneous implantation of spinal electrodes
* Untreated clinical diagnosis of psychiatric disorder
* Joint contractures that impede typical range of motion
* Non-MRI-compatible implanted medical devices
* Other implanted stimulation devices (e.g. deep brain stimulator, cardiac pacemaker, diaphragmatic pacer, etc.)
* Undergoing, or planning to undergo, diathermy treatment
* Active participation in an interventional clinical trial
* History of clinically-diagnosed cardiopulmonary disorder, such as severe orthostatic hypotension, which may impede participation in rehabilitation activities such as changes in body position such as supine-to-sit-to-stand activities, prolonged standing, or stepping
* History of frequent and/or severe autonomic dysreflexia
* History of seizure disorder
* Any illness or condition which, based on the research team's assessment, will compromise with the patient's ability to comply with the protocol, patient safety, or the validity of the data collected during this study

Contacts and Locations

Principal Investigator

Peter J. Grahn, Ph.D.

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Peter J. Grahn, Ph.D.

Peter J. Grahn, Ph.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic

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 Date2021-09-24

Study Completion Date2025-03-19

Study Record Updates

Study Start Date2021-09-24

Study Completion Date2025-03-19

Terms related to this study

Additional Relevant MeSH Terms

Spinal Cord Injuries
Paraplegia
Tetraplegia
Paralysis