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

Not Applicable

Terminated

• Conditions: Paraplegia, Complete; Paraplegia; Traumatic; Paraplegia, Spinal
• Interventions: Device: Transcutaneous spinal cord stimulator; Device: Epidural spinal cord stimulation system

• Registration Number: NCT03945331
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-22
• Study First Submitted: 2019-04-28
• Study First Submitted QC: 2019-05-09
• Study First Posted: 2019-05-10
• Primary Completion: 2020-06-17
• Study Completion: 2020-06-17
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-15
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EES	Transcutaneous spinal cord stimulator	TESS, used during the initial 6-month training period, followed by Epidural Electrical Stimulation (EES) during the final 6-month training period.
TESS	Transcutaneous spinal cord stimulator	Transcutaneous Electrical Spinal Stimulation (TESS), used during all training sessions.
EES	Epidural spinal cord stimulation system	TESS, used during the initial 6-month training period, followed by Epidural Electrical Stimulation (EES) during the final 6-month training period.

Primary Outcome Measures

Name	Time	Method
Kinematics	Baseline, Month 3, Month 6, End of Month 7, Month 10, Month 13	Change in measurements of joint angles using video-based, inertial measurement, and/or electromagnetic markers.
Electromyography	Baseline, Month 3, Month 6, End of Month 7, Month 10, Month 13	Change in measurements of electrical activity at major muscle groups below the level of injury.
Foot pressure	Baseline, Month 3, Month 6, End of Month 7, Month 10, Month 13	Change in measurements of foot pressure through shoe-insole pressure sensors.
Somatosensory evoked potentials	Baseline, Month 6, End of Month 7, Month 13	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.
Transcranial magnetic stimulation motor evoked potentials	Baseline, Month 6, End of Month 7, Month 13	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.
Monosynaptic spinal reflex testing	Baseline, Month 6, End of Month 7, Month 13	Change in measurements of stimulation intensity H and F wave thresholds and maximal responses through surface electrodes.
Trunk stability	Baseline, Month 3, Month 6, End of Month 7, Month 10, Month 13	Change in measurements of trunk stability using the modified functional reach test (mFRT).
Injury severity: American Spinal Injury Association Impairment Scale (AIS)	Baseline, Month 6, End of Month 7, Month 13	Change in measurements of impairment of sensory and motor functions using the American Spinal Injury Association Impairment Scale (AIS). Individuals are classified from A" (complete spinal cord injury) to "E" (normal function). 28 dermatomes and 10 key muscles are assessed bilaterally. Results are summed to produce overall sensory and motor scores and are used in combination with evaluation of anal sensory and motor function as a basis for the determination of AIS classification. Sensory scores are rated 0 (sensation absent) to 2 (normal), bilaterally for each of 28 dermatomes. Muscle function is rated 0 (total paralysis) to 5 (active movement, full range of motion against significant resistance) for each myotome. Upper Extremity Motor Subscores and Lower Extremity Motor Subscores are each scored from 0 to 50; the ASIA Motor Score is scored from 0 to 100. The presence of anal sensation and voluntary anal contraction are assessed as a yes/no.

Secondary Outcome Measures

Name	Time	Method
Bowel function	Baseline, Month 6, Month 13	Change in measurements of bowel function utilizing anorectal manometry.
Bladder function	Baseline, Month 6, Month 13	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.
Spasticity	Baseline, Month 3, Month 6, End of Month 7, Month 10, Month 13	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.
Bone mineral density	Baseline, Month 6, Month 13	Measurement by dual-energy x-ray absorptiometry (DXA) of change in bone mineral content and bone density.
Body composition - body fat mass	Baseline, Month 6, End of Month 7, Month 13	Measurement by dual-energy x-ray absorptiometry (DXA) of change in regional and total body fat mass.
Body composition - lean mass	Baseline, Month 6, End of Month 7, Month 13	Measurement by dual-energy x-ray absorptiometry (DXA) of change in regional and total lean mass.
Body composition - android and gynoid fat percentage	Baseline, Month 6, End of Month 7, Month 13	Measurement by dual-energy x-ray absorptiometry (DXA) of change in regional and total android and gynoid fat percentage.
Body composition - android and gynoid fat ratio	Baseline, Month 6, End of Month 7, Month 13	Measurement by dual-energy x-ray absorptiometry (DXA) of change in regional and total android to gynoid fat ratio.
Body composition - bone mass	Baseline, Month 6, End of Month 7, Month 13	Measurement by dual-energy x-ray absorptiometry (DXA) of change in regional and total bone mass.
Knee cartilage health	Baseline, Month 6; Month 13 for TESS cohort only	Assessment of change in knee cartilage breakdown using the modified Outerbridge classification or the International Cartilage Repair Society classification, utilizing magnetic resonance imaging (MRI).
Metabolics - CBC	Baseline, Month 6, End of Month 7, Month 13	Measurement of changes in complete blood count with differential.
Male patient-reported sexual function (1)	Baseline, Month 6, End of Month 7, Month 13	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.
Male patient-reported sexual function (2)	Baseline, Month 6, End of Month 7, Month 13	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.
Male patient-reported sexual function (3)	Baseline, Month 6, End of Month 7, Month 13	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.
Female patient-reported sexual function (1)	Baseline, Month 6, End of Month 7, Month 13	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.
Female patient-reported sexual function (2)	Baseline, Month 6, End of Month 7, Month 13	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.
Patient-reported quality of life (1): Spinal Cord Injury Secondary Conditions Scale (SCI-SCS)	Baseline, Month 6, End of Month 7, Month 13	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.
Metabolics - glucose	Baseline, Month 6, End of Month 7, Month 13	Measurement of change in fasting glucose value.
Metabolics - total cholesterol	Baseline, Month 6, End of Month 7, Month 13	Measurement of change in total cholesterol value.
Metabolics - HDL cholesterol	Baseline, Month 6, End of Month 7, Month 13	Measurement of change in HDL cholesterol value.
Metabolics - calculated LDL cholesterol	Baseline, Month 6, End of Month 7, Month 13	Measurement of change in calculated LDL cholesterol value.
Metabolics - triglycerides	Baseline, Month 6, End of Month 7, Month 13	Measurement of change in triglycerides value.
Metabolics - non-HDL cholesterol	Baseline, Month 6, End of Month 7, Month 13	Measurement of change in non-HDL cholesterol value.
Spinal structural integrity	Baseline	Assessment of structural integrity via computerized tomography (CT).
Injury severity and potential for spared tissue	Baseline	Evaluation of severity and possibility of discomplete injury despite complete loss of motor function via MRI.
Stimulator array location and migration (EES cohort only)	End of Month 7, Month 13	Evaluation of current array location via CT.
Patient-reported bowel function (1)	Baseline, Month 6, End of Month 7, Month 13	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.
Patient-reported bowel function (2)	Baseline, Month 6, End of Month 7, Month 13	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.
Patient-reported bladder function (1)	Baseline, Month 6, End of Month 7, Month 13	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.
Patient-reported bladder function (2)	Baseline, Month 6, End of Month 7, Month 13	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.
Patient-reported quality of life (2): World Health Organization Quality of Life Questionnaire (WHOQOL-BREF)	Baseline, Month 6, End of Month 7, Month 13	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.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States