Back to results

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

Primary Purpose

Paraplegia, Spinal, Paraplegia, Complete, Paraplegia; Traumatic

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Transcutaneous spinal cord stimulator

Epidural spinal cord stimulation system

About this trial

This is an interventional device feasibility trial for Paraplegia, Spinal

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

TESS

EES

Arm Description

Transcutaneous Electrical Spinal Stimulation (TESS), used during all training sessions.

TESS, used during the initial 6-month training period, followed by Epidural Electrical Stimulation (EES) during the final 6-month training period.

Outcomes

Primary Outcome Measures

Kinematics

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

Electromyography

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

Foot pressure

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

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.

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.

Monosynaptic spinal reflex testing

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

Trunk stability

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

Injury severity: American Spinal Injury Association Impairment Scale (AIS)

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

Bowel function

Change in measurements of bowel function utilizing anorectal manometry.

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.

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.

Bone mineral density

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

Body composition - body fat mass

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

Body composition - lean mass

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

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.

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.

Body composition - bone mass

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

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).

Metabolics - CBC

Measurement of changes in complete blood count with differential.

Metabolics - glucose

Measurement of change in fasting glucose value.

Metabolics - total cholesterol

Measurement of change in total cholesterol value.

Metabolics - HDL cholesterol

Measurement of change in HDL cholesterol value.

Metabolics - calculated LDL cholesterol

Measurement of change in calculated LDL cholesterol value.

Metabolics - triglycerides

Measurement of change in triglycerides value.

Metabolics - non-HDL cholesterol

Measurement of change in non-HDL cholesterol value.

Spinal structural integrity

Assessment of structural integrity via computerized tomography (CT).

Injury severity and potential for spared tissue

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

Stimulator array location and migration (EES cohort only)

Evaluation of current array location via CT.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT03945331

First Posted

April 28, 2019

Last Updated

October 15, 2020

Sponsor

Mayo Clinic

Collaborators

Minnesota Office of Higher Education

1. Study Identification

Unique Protocol Identification Number

NCT03945331

Brief Title

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

Acronym

TransEpi

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Terminated

Why Stopped

COVID-19 disrupted interventions irrecoverably.

Study Start Date

January 22, 2019 (Actual)

Primary Completion Date

June 17, 2020 (Actual)

Study Completion Date

June 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

Collaborators

Minnesota Office of Higher Education

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Paraplegia, Spinal, Paraplegia, Complete, Paraplegia; Traumatic

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TESS

Arm Type

Experimental

Arm Description

Transcutaneous Electrical Spinal Stimulation (TESS), used during all training sessions.

Arm Title

EES

Arm Type

Experimental

Arm Description

TESS, used during the initial 6-month training period, followed by Epidural Electrical Stimulation (EES) during the final 6-month training period.

Intervention Type

Device

Intervention Name(s)

Transcutaneous spinal cord stimulator

Intervention Description

DS8R Electrical Stimulator For Human Research

Intervention Type

Device

Intervention Name(s)

Epidural spinal cord stimulation system

Intervention Description

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

Primary Outcome Measure Information:

Title

Kinematics

Description

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

Title

Electromyography

Description

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

Title

Foot pressure

Description

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

Title

Somatosensory evoked potentials

Description

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

Title

Transcranial magnetic stimulation motor evoked potentials

Description

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

Title

Monosynaptic spinal reflex testing

Description

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

Title

Trunk stability

Description

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

Title

Injury severity: American Spinal Injury Association Impairment Scale (AIS)

Description

Time Frame

Baseline, Month 6, End of Month 7, Month 13

Secondary Outcome Measure Information:

Title

Bowel function

Description

Change in measurements of bowel function utilizing anorectal manometry.

Time Frame

Baseline, Month 6, Month 13

Title

Bladder function

Description

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

Title

Spasticity

Description

Time Frame

Baseline, Month 3, Month 6, End of Month 7, Month 10, Month 13

Title

Bone mineral density

Description

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

Time Frame

Baseline, Month 6, Month 13

Title

Body composition - body fat mass

Description

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

Title

Body composition - lean mass

Description

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

Title

Body composition - android and gynoid fat percentage

Description

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

Title

Body composition - android and gynoid fat ratio

Description

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

Title

Body composition - bone mass

Description

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

Title

Knee cartilage health

Description

Time Frame

Baseline, Month 6; Month 13 for TESS cohort only

Title

Metabolics - CBC

Description

Measurement of changes in complete blood count with differential.

Time Frame

Baseline, Month 6, End of Month 7, Month 13

Title

Metabolics - glucose

Description

Measurement of change in fasting glucose value.

Time Frame

Baseline, Month 6, End of Month 7, Month 13

Title

Metabolics - total cholesterol

Description

Measurement of change in total cholesterol value.

Time Frame

Baseline, Month 6, End of Month 7, Month 13

Title

Metabolics - HDL cholesterol

Description

Measurement of change in HDL cholesterol value.

Time Frame

Baseline, Month 6, End of Month 7, Month 13

Title

Metabolics - calculated LDL cholesterol

Description

Measurement of change in calculated LDL cholesterol value.

Time Frame

Baseline, Month 6, End of Month 7, Month 13

Title

Metabolics - triglycerides

Description

Measurement of change in triglycerides value.

Time Frame

Baseline, Month 6, End of Month 7, Month 13

Title

Metabolics - non-HDL cholesterol

Description

Measurement of change in non-HDL cholesterol value.

Time Frame

Baseline, Month 6, End of Month 7, Month 13

Title

Spinal structural integrity

Description

Assessment of structural integrity via computerized tomography (CT).

Time Frame

Baseline

Title

Injury severity and potential for spared tissue

Description

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

Time Frame

Baseline

Title

Stimulator array location and migration (EES cohort only)

Description

Evaluation of current array location via CT.

Time Frame

End of Month 7, Month 13

Title

Patient-reported bowel function (1)

Description

Time Frame

Baseline, Month 6, End of Month 7, Month 13

Title

Patient-reported bowel function (2)

Description

Time Frame

Baseline, Month 6, End of Month 7, Month 13

Title

Patient-reported bladder function (1)

Description

Time Frame

Baseline, Month 6, End of Month 7, Month 13

Title

Patient-reported bladder function (2)

Description

Time Frame

Baseline, Month 6, End of Month 7, Month 13

Title

Male patient-reported sexual function (1)

Description

Time Frame

Baseline, Month 6, End of Month 7, Month 13

Title

Male patient-reported sexual function (2)

Description

Time Frame

Baseline, Month 6, End of Month 7, Month 13

Title

Male patient-reported sexual function (3)

Description

Time Frame

Baseline, Month 6, End of Month 7, Month 13

Title

Female patient-reported sexual function (1)

Description

Time Frame

Baseline, Month 6, End of Month 7, Month 13

Title

Female patient-reported sexual function (2)

Description

Time Frame

Baseline, Month 6, End of Month 7, Month 13

Title

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

Description

Time Frame

Baseline, Month 6, End of Month 7, Month 13

Title

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

Description

Time Frame

Baseline, Month 6, End of Month 7, Month 13

Other Pre-specified Outcome Measures:

Title

Volitional movement (1)

Description

Measurement of change in volitional movement through recordings of training time in minutes.

Time Frame

1 year

Title

Volitional movement (2)

Description

Measurement of change in volitional movement through recordings body weight support measured as a percentage of total body weight supported.

Time Frame

1 year

Title

Volitional movement (3)

Description

Measurement of change in volitional movement through recordings of speed in miles per hour.

Time Frame

1 year

Title

Volitional movement (4)

Description

Measurement of changes in volitional movement through recordings of assistive devices used.

Time Frame

1 year

Title

Volitional movement (5)

Description

Measurement of changes in volitional movement through recordings of stimulator electrode location.

Time Frame

1 year, for TESS cohort only

Title

Volitional movement (6)

Description

Measurement of changes in volitional movement through recordings of stimulator intensity, measured in milliamps per volt.

Time Frame

1 year

Title

Volitional movement (7)

Description

Measurements of changes in volitional movement through recordings of stimulator frequency measured in Hertz.

Time Frame

1 year

Title

Volitional movement (8)

Description

Measurement of changes in volitional movement through recordings of pulse width, measured in microseconds.

Time Frame

1 year

Title

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

Description

Measurement of changes in overground mobility as measured by the SCI Functional Ambulation Inventory. Trainer ratings of various gait parameters and criteria are rated from 0 to 5, with a higher number indicating better walking mobility, and totaled for a score which characterizes overall functional ambulation.

Time Frame

1 year

Title

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

Description

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

1 year

Title

Overground ambulation [as appropriate to the subject] (3)

Description

Measurement of changes in overground mobility as measured by the Modified Timed Up and Go test. Trainers will assess the time it takes, in minutes and seconds, for the subject to stand from a chair, move out to a 3 meter distance, return to the chair and sit down. Less time will characterize better overground mobility.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kristin D. Zhao, Ph.D.

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

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

We'll reach out to this number within 24 hrs