Transcutaneous and Epidural Spinal Stimulation for Enabling Motor Function in Humans With Motor Complete Paraplegia

Mayo Clinic2 enrolled

Overview

The purpose of this study is to compare transcutaneous electrical spinal stimulation (TESS) and epidural electrical stimulation (EES); in particular, the motor activity enabled by each method and the potential health benefits of each method.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Paraplegia, Spinal Paraplegia, Complete Paraplegia; Traumatic

Interventions

Transcutaneous spinal cord stimulatorDEVICE

DS8R Electrical Stimulator For Human Research

Epidural spinal cord stimulation systemDEVICE

Spectra WaveWriter Epidural Spinal Cord Stimulator System with CoverEdge 32 Electrode Surgical Lead

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

Inclusion Criteria * Spinal cord injury due to trauma located between the seventh cervical and tenth thoracic vertebrae * American Spinal Injury Association grading scale of A or B (at least 4 each of A and B) below the level of SCI * Intact spinal reflexes below the level of SCI * At least 1-year post-SCI * At least 22 years of age * Willing to use medically acceptable methods of contraception, if female and of child-bearing potential Exclusion Criteria * Currently a prison inmate, or awaiting trial, related to criminal activity * Pregnancy at the time of enrollment * DEXA t score \<-3.5 at spine and femur head * History of chronic and/or treatment resistant urinary tract infection * Unhealed decubitus ulcer * Unhealed skeletal fracture * Untreated clinical diagnosis of depression * Presence of joint contractures or an Ashworth spasticity score of 4 * Active anti-spasticity medication regimen within 3 months prior to study enrollment * Presence of transcranial magnetic stimulation-evoked potentials in leg muscles * Non MRI-compatible implanted medical devices. * Undergoing, or planning to undergo, diathermy treatment * Active participation in another interventional clinical trial * Presence of conditions or disorders which require MRI monitoring * For EES cohort subjects, a history of coagulopathy or other significant cardiac or medical risk factors for surgery * Current use of a ventilator * Clinically diagnosed cardiopulmonary complications such as chronic obstructive pulmonary disease, cardiac failure, or heart arrhythmia that contraindicate changes in body position such as supine-to-sit-to-stand activities, prolonged standing, or stepping * Mass \> 113 kg (250 pounds) * History of frequent hypotension characterized by light headedness, or loss of consciousness * History of frequent hypertension characterized by headache, or bradycardia * History of frequent, severe, autonomic dysreflexia * 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

Kinematics

Change in measurements of joint angles using video-based, inertial measurement, and/or electromagnetic markers.

Time frame: Baseline, Month 3, Month 6, End of Month 7, Month 10, Month 13

Electromyography

Change in measurements of electrical activity at major muscle groups below the level of injury.

Time frame: Baseline, Month 3, Month 6, End of Month 7, Month 10, Month 13

Foot pressure

Change in measurements of foot pressure through shoe-insole pressure sensors.

Time frame: Baseline, Month 3, Month 6, End of Month 7, Month 10, Month 13

Somatosensory evoked potentials

Change in measurements of change in conduction in the peripheral nerves, cervical and lumbosacral spinal cord, deep brain structures, and sensory cortex, through surface electrodes.

Time frame: Baseline, Month 6, End of Month 7, Month 13

Transcranial magnetic stimulation motor evoked potentials

Change in measurements of stimulus intensity required to elicit muscle responses in muscle groups known to elicit optimal motor evoked potential responses, both above and below the level of injury.

Time frame: Baseline, Month 6, End of Month 7, Month 13

Monosynaptic spinal reflex testing

Change in measurements of stimulation intensity H and F wave thresholds and maximal responses through surface electrodes.

Time frame: Baseline, Month 6, End of Month 7, Month 13

Trunk stability

Change in measurements of trunk stability using the modified functional reach test (mFRT).

Time frame: Baseline, Month 3, Month 6, End of Month 7, Month 10, Month 13

Data from ClinicalTrials.gov

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Secondary Outcomes

Bowel function

Change in measurements of bowel function utilizing anorectal manometry.

Time frame: Baseline, Month 6, Month 13

Bladder function

Change in measurements of bladder function utilizing a urodynamic test consisting of a filling phase and a voiding phase cystometrogram along with perineal patch muscle electromyography.

Time frame: Baseline, Month 6, Month 13

Spasticity

Change in measurements of spasticity using the Modified Ashworth Scale (MAS), an assessment which measures resistance during passive soft-tissue stretching of bilateral hip flexors, extensors, adductors, and abductors, knee extensors and flexors, and ankle plantarflexors and dorsiflexors. Scoring is scaled from 0 (no increase in muscle tone) to 4 (affected part\[s\] rigid in flexion or extension), with higher scores indicating more spasticity.

Time frame: Baseline, Month 3, Month 6, End of Month 7, Month 10, Month 13

Bone mineral density

Measurement by dual-energy x-ray absorptiometry (DXA) of change in bone mineral content and bone density.

Time frame: Baseline, Month 6, Month 13

Body composition - body fat mass

Measurement by dual-energy x-ray absorptiometry (DXA) of change in regional and total body fat mass.

Time frame: Baseline, Month 6, End of Month 7, Month 13

Body composition - lean mass

Measurement by dual-energy x-ray absorptiometry (DXA) of change in regional and total lean mass.

Time frame: Baseline, Month 6, End of Month 7, Month 13

Body composition - android and gynoid fat percentage

Measurement by dual-energy x-ray absorptiometry (DXA) of change in regional and total android and gynoid fat percentage.

Time frame: Baseline, Month 6, End of Month 7, Month 13

Body composition - android and gynoid fat ratio

Measurement by dual-energy x-ray absorptiometry (DXA) of change in regional and total android to gynoid fat ratio.

Time frame: Baseline, Month 6, End of Month 7, Month 13

Body composition - bone mass

Measurement by dual-energy x-ray absorptiometry (DXA) of change in regional and total bone mass.

Time frame: Baseline, Month 6, End of Month 7, Month 13

Knee cartilage health

Assessment of change in knee cartilage breakdown using the modified Outerbridge classification or the International Cartilage Repair Society classification, utilizing magnetic resonance imaging (MRI).

Time frame: Baseline, Month 6; Month 13 for TESS cohort only

Metabolics - CBC

Measurement of changes in complete blood count with differential.

Time frame: Baseline, Month 6, End of Month 7, Month 13

Metabolics - glucose

Measurement of change in fasting glucose value.

Time frame: Baseline, Month 6, End of Month 7, Month 13

Metabolics - total cholesterol

Measurement of change in total cholesterol value.

Time frame: Baseline, Month 6, End of Month 7, Month 13

Metabolics - HDL cholesterol

Measurement of change in HDL cholesterol value.

Time frame: Baseline, Month 6, End of Month 7, Month 13

Metabolics - calculated LDL cholesterol

Measurement of change in calculated LDL cholesterol value.

Time frame: Baseline, Month 6, End of Month 7, Month 13

Metabolics - triglycerides

Measurement of change in triglycerides value.

Time frame: Baseline, Month 6, End of Month 7, Month 13

Metabolics - non-HDL cholesterol

Measurement of change in non-HDL cholesterol value.

Time frame: Baseline, Month 6, End of Month 7, Month 13

Spinal structural integrity

Assessment of structural integrity via computerized tomography (CT).

Time frame: Baseline

Injury severity and potential for spared tissue

Evaluation of severity and possibility of discomplete injury despite complete loss of motor function via MRI.

Time frame: Baseline

Stimulator array location and migration (EES cohort only)

Evaluation of current array location via CT.

Time frame: End of Month 7, Month 13

Patient-reported bowel function (1)

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.

Time frame: Baseline, Month 6, End of Month 7, Month 13

Patient-reported bowel function (2)

Measurement of change in bowel function using the International Spinal Cord Injury Bowel Function Basic Data Set (v2.0). Answers to qualitative questions are rated from 0 to 13, with a higher number indicating more problematic symptoms, and totaled for a score which categorizes neurogenic bowel dysfunction.

Time frame: Baseline, Month 6, End of Month 7, Month 13

Patient-reported bladder function (1)

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.

Time frame: Baseline, Month 6, End of Month 7, Month 13

Patient-reported bladder function (2)

Assessment of change in bowel function using the International Spinal Cord Injury Urodynamic Basic Data Set. Data from various urodynamic variables are aggregated into a single-page format for an abstract overview of bladder dysfunction.

Time frame: Baseline, Month 6, End of Month 7, Month 13

Male patient-reported sexual function (1)

Assessment of change in sexual function using the International Spinal Cord Injury Male Sexual Function Basic Data Set (v2.0). Data from various male sexual function variables are aggregated into a single-page format for an abstract overview of male sexual dysfunction.

Time frame: Baseline, Month 6, End of Month 7, Month 13

Male patient-reported sexual function (2)

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.

Time frame: Baseline, Month 6, End of Month 7, Month 13

Male patient-reported sexual function (3)

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.

Time frame: Baseline, Month 6, End of Month 7, Month 13

Female patient-reported sexual function (1)

Assessment of change in sexual function using the International Spinal Cord Injury Female Sexual and Reproductive Function Basic Data Set (v2.0). Data from various female sexual and reproductive function variables are aggregated into a single-page format for an abstract overview of female sexual and reproductive dysfunction.

Time frame: Baseline, Month 6, End of Month 7, Month 13

Female patient-reported sexual function (2)

Measurement of change in sexual function using the Female Sexual Function Index (FSFI). Answers to qualitative questions are rated from 0 to 5, with a higher number indicating better sexual function, and totaled for a score which categorizes severity of sexual dysfunction.

Time frame: Baseline, Month 6, End of Month 7, Month 13

Patient-reported quality of life (1): Spinal Cord Injury Secondary Conditions Scale (SCI-SCS)

Measurements of change to quality of life as measured by the Spinal Cord Injury Secondary Conditions Scale (SCI-SCS). Answers to qualitative questions regarding patient activities, independence, and overall quality of life are rated from 0 to 3, with a higher number indicating more significant or chronic problems, and totaled for a score which categorizes patient quality of life.

Time frame: Baseline, Month 6, End of Month 7, Month 13

Patient-reported quality of life (2): World Health Organization Quality of Life Questionnaire (WHOQOL-BREF)

Measurement of change to quality of life as measured by the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF). Answers to qualitative questions regarding patient activities, independence, and overall quality of life are rated from 1 to 5, with a higher number indicating a higher concurrence or frequency related to the item in question, and totaled for a score which categorizes patient quality of life.

Time frame: Baseline, Month 6, End of Month 7, Month 13