Transcutaneous and Epidural Stimulation in SCI

Kristin Zhao, PhD

Overview

The study seeks to improve the scientific understanding of how two electrical stimulation techniques, one which delivers electricity to the skin surface over the spine (transcutaneous electrical spinal stimulation \[TESS\]) and another which is implanted onto the dura mater of the spinal cord (epidural electrical stimulation \[EES\]), facilitate spinal circuitry to enable function after SCI.

The study will compare motor activity and clinical outcomes over the course of TESS and EES in combination with physical rehabilitation. The primary outcome data collected will be used to characterize and compare spinal sensorimotor activity in muscles below the level of injury during TESS and EES-enabled motor tasks in persons with chronic motor complete paralysis of the lower extremities due to traumatic SCI. Furthermore, data collected will be used as a proof of concept that TESS can be used to determine recovery of function during EES-enabled motor tasks. Following exposure to each stimulation intervention, data collection will include changes to spasticity, body composition, metabolic variables, and spinal imaging to assess the effect of either TESS or EES stimulation.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Conditions

Paraplegia, Spinal Paraplegia, Complete Paraplegia; Traumatic

Interventions

Transcutaneous spinal cord stimulatorDEVICE

DS8R Electrical Stimulator For Human Research

Epidural spinal cord stimulator 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 (C7) and tenth thoracic vertebrae (T10) * American Spinal Injury Association grading scale of A or B (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 * Dual energy x-ray absorptiometry (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 * Undergoing, or planning to undergo, diathermy treatment * Active participation in another interventional clinical trial * Presence of conditions or disorders which require MRI monitoring * 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.

Outcomes

Primary Outcomes

Kinematics

Change in measurements of joint angles, measured in degrees.

Time frame: Baseline, End of TESS, Start of EES, End month 6 EES

Electromyography

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

Time frame: Baseline, End of TESS, Start of EES, End month 6 EES

Foot pressure

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

Time frame: Baseline, End of TESS, Start of EES, End month 6 EES

Overground ambulation [as appropriate to the subject] (1)

Measurement of changes in overground mobility as measured by the Modified 6 Minute Walk Test. Trainers will assess the distance in meters which the subject can cover in 6 minutes, with a greater distance characterizing better overground mobility.

Time frame: Baseline, End of TESS, Start of EES, End month 6 EES

Overground ambulation [as appropriate to the subject] (2)

Measurement of changes in walking impairment as measured by the Walking Index for Spinal Cord Injury. Trainers will assess overall level of impairment, ranging from most severe impairment (0) to least severe impairment (20), based on the use of devices, braces, and physical assistance of one or more persons.

Time frame: Baseline, End of TESS, Start of EES, End month 6 EES

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, End of TESS, Start of EES, End month 6 EES

Transcranial magnetic stimulation motor evoked potentials

Data from ClinicalTrials.gov

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Secondary Outcomes

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. Scores are totaled for a score which categorizes the overall positive or negative impact of a subject's spasticity symptoms.

Time frame: Baseline, End of TESS, Start of EES, End month 6 EES

Bone mineral density

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

Time frame: Baseline, End of TESS, Start of EES, End month 6 EES

Body composition - body fat mass

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

Time frame: Baseline, End of TESS, Start of EES, End month 6 EES

Body composition - lean mass

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

Time frame: Baseline, End of TESS, Start of EES, End month 6 EES

Body composition - android and gynoid fat percentage

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

Time frame: Baseline, End of TESS, Start of EES, End month 6 EES

Body composition - bone mass

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

Time frame: Baseline, End of TESS, Start of EES, End month 6 EES

Metabolics - CBC

Measurement of changes in complete blood count with differential.

Time frame: Baseline, End of TESS, Start of EES, End month 6 EES

Metabolics - glucose

Measurement of change in fasting glucose value.

Time frame: Baseline, End of TESS, Start of EES, End month 6 EES

Metabolics - total cholesterol

Measurement of change in total cholesterol value.

Time frame: Baseline, End of TESS, Start of EES, End month 6 EES

Metabolics - HDL cholesterol

Measurement of change in HDL cholesterol value.

Time frame: Baseline, End of TESS, Start of EES, End month 6 EES

Metabolics - calculated LDL cholesterol

Measurement of change in calculated LDL cholesterol value.

Time frame: Baseline, End of TESS, Start of EES, End month 6 EES

Metabolics - triglycerides

Measurement of change in triglycerides value.

Time frame: Baseline, End of TESS, Start of EES, End month 6 EES

Metabolics - non-HDL cholesterol

Measurement of change in non-HDL cholesterol value.

Time frame: Baseline, End of TESS, Start of EES, End month 6 EES

Neurostimulator array location and migration

Evaluation of current array location via CT.

Time frame: Start of EES, End month 6 EES

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, End of TESS, Start of EES, End month 6 EES

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, End of TESS, Start of EES, End month 6 EES

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, End of TESS, Start of EES, End month 6 EES

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, End of TESS, Start of EES, End month 6 EES

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, End of TESS, Start of EES, End month 6 EES

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, End of TESS, Start of EES, End month 6 EES

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, End of TESS, Start of EES, End month 6 EES

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, End of TESS, Start of EES, End month 6 EES

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, End of TESS, Start of EES, End month 6 EES