Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury

Peter J. Grahn, Ph.D.22 enrolled

Overview

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.

This study aims to expand the understanding of how electrical spinal stimulation enables function, specifically the pathophysiological mechanisms of action underlying spinal electrical stimulation after SCI, and to address the gap in knowledge of spinal sensorimotor network inputs and outputs generated by spinal electrical stimulation in humans with SCI.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Spinal Cord Injuries Paraplegia Tetraplegia Paralysis

Interventions

Percutaneous epidural and dorsal root stimulationDEVICE

Abbott percutaneous trial lead for dorsal root ganglion neurostimulation (Model MN10350) Abbott percutaneous trial lead for epidural neurostimulation (Model 3086) Abbott clinician programmer for epidural and dorsal root ganglion neurostimulation (Model 3874) Ripple Neuromed Nomad Neurostimulation System

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

Inclusion 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 Exclusion Criteria: * 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

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Electromyography

Percent change in EMG voltage from beginning to end of intervention, recorded from the rectus femoris, during epidural and dorsal root spinal stimulation.

Time frame: Assessed at Day 1 (beginning of intervention) and Day 10 (end of intervention).

Foot Pressure

Measurements of foot pressure from shoe-insole sensors during no-stimulation bilaterally assisted standing and unassisted standing with stimulation.

Time frame: Assessed at Day 10 (end of intervention).

Somatosensory Evoked Potentials

Change from baseline to end of study, in amplitude of evoked potentials recorded from sensory cortex using skin surface electrodes during electrical stimulation of the right and left tibial nerve.

Time frame: Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).

Transcranial Magnetic Stimulation Motor Evoked Potentials

Change in intensity of stimulation, reported as percentage (0% to 100%) of maximum system output, required to elicit motor-evoked potentials below the level of injury.

Time frame: Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).

American Spinal Injury Association Grading Scale

Severity of spinal cord injury impairment will be assessed at baseline and end of study to examine changes in impairment that may be associated with the intervention.

Time frame: Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).

Spasticity

Change in measurements of spasticity using the Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET). Answers to qualitative questions are rated from -3 to +3, with a higher positive number indicating more helpful symptoms, and a lower negative number indicating more problematic symptoms. Questions may also be answered as not applicable (N/A), which do not generate a score. Scores are totaled for a score which categorizes the overall positive or negative impact of a subject's spasticity symptoms. Total score can range from -105 (negative impact) to +105 (positive impact), and the score is averaged by total positive or negative score divided by the number of applicable answers.

Data from ClinicalTrials.gov

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Secondary Outcomes

Patient-reported Bowel Function

Measurement of change in bowel function using the Neurogenic Bowel Dysfunction Score. Answers to qualitative questions are rated from 0 to 5, with a higher number indicating more problematic symptoms, and totaled for a score which categorizes severity of neurogenic bowel symptoms. The total score ranges between 0 and 44 points. A higher total score indicates more severe bowel symptoms.

Time frame: Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).

Patient-reported Bladder Function

Measurement of change in bladder function using the Neurogenic Bladder Symptom Score. Answers to qualitative questions are rated from 0 to 5, with a higher number indicating more problematic symptoms, and totaled for a score which categorizes severity of neurogenic bladder symptoms. The total score can range from 0 (no symptoms at all) to 74 (maximum symptoms).

Time frame: Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).

Male Patient-reported Sexual Function (SHIM)

Measurement of change in erectile dysfunction using the Sexual Health Inventory for Men (SHIM). Answers to qualitative questions are rated from 0 to 5, with a higher number indicating better erectile function, and totaled for a score which categorizes severity of erectile dysfunction. Total score can range from 1 to 25, with a lower number indicating more severe erectile dysfunction.

Time frame: Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).

Male Patient-reported Sexual Function (IEF)

Measurement of change in erectile dysfunction using the International Index for Erectile Function (IIEF). Answers to qualitative questions are rated from 0 to 5, with a higher number indicating better erectile function, and totaled for a score which categorizes severity of erectile dysfunction. Total scores range from 5 to 25, with a lower score indicating more severe erectile dysfunction.

Time frame: Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).

Neurostimulation User Experience

Rating of the subject's perception of individual aspects of spinal stimulation using the User Experience Questionnaire (UEQ), a survey including 26 descriptive terms and their antonyms. A scoring scale ranging from 1 to 7 determines how closely the subject feels the term or its antonym applies to the intervention, with lower numbers indicating agreement with the term, and higher numbers indicating agreement with the antonym. The terms and antonyms describe a positive and negative perception of each item.

Time frame: Assessed at end of study ( after day 10 of intervention).