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Paraplegia, SpinalTransEpiNCT03945331

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

A study testing Transcutaneous spinal cord stimulator and Epidural spinal cord stimulation system in people with Paraplegia, Spinal and Paraplegia, Complete, run by Mayo Clinic at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 22 years and older
What is being tested?
Transcutaneous spinal cord stimulator and Epidural spinal cord stimulation system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
22 Jan 2019to 17 Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 22Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

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

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.

Being tested
Transcutaneous spinal cord stimulator, Epidural spinal cord stimulation system
Medical subject headings
Paraplegia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT03945331
Study groupRoleWhat they receive
TESSExperimentalTranscutaneous Electrical Spinal Stimulation (TESS), used during all training sessions.
Receives: Device: Transcutaneous spinal cord stimulator
EESExperimentalTESS, used during the initial 6-month training period, followed by Epidural Electrical Stimulation (EES) during the final 6-month training period.
Receives: Device: Transcutaneous spinal cord stimulator; Device: Epidural spinal cord stimulation system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Kinematics

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

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

  2. Electromyography

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

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

  3. Foot pressure

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

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

  4. 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.

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

  5. 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.

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

  6. Monosynaptic spinal reflex testing

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

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

  7. Trunk stability

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

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

  8. 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.

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

Secondary outcomes (31)

  1. Bowel function

    Change in measurements of bowel function utilizing anorectal manometry.

    Measured: Baseline, Month 6, Month 13

  2. 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.

    Measured: Baseline, Month 6, Month 13

  3. 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.

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

  4. Bone mineral density

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

    Measured: Baseline, Month 6, Month 13

  5. Body composition - body fat mass

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

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

  6. Body composition - lean mass

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

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

  7. 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.

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

  8. 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.

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

  9. Body composition - bone mass

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

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

  10. 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).

    Measured: Baseline, Month 6; Month 13 for TESS cohort only

  11. Metabolics - CBC

    Measurement of changes in complete blood count with differential.

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

  12. Metabolics - glucose

    Measurement of change in fasting glucose value.

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

  13. Metabolics - total cholesterol

    Measurement of change in total cholesterol value.

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

  14. Metabolics - HDL cholesterol

    Measurement of change in HDL cholesterol value.

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

  15. Metabolics - calculated LDL cholesterol

    Measurement of change in calculated LDL cholesterol value.

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

  16. Metabolics - triglycerides

    Measurement of change in triglycerides value.

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

  17. Metabolics - non-HDL cholesterol

    Measurement of change in non-HDL cholesterol value.

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

  18. Spinal structural integrity

    Assessment of structural integrity via computerized tomography (CT).

    Measured: Baseline

  19. Injury severity and potential for spared tissue

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

    Measured: Baseline

  20. Stimulator array location and migration (EES cohort only)

    Evaluation of current array location via CT.

    Measured: End of Month 7, Month 13

  21. 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.

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

  22. 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.

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

  23. 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.

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

  24. 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.

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

  25. 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.

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

  26. 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.

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

  27. 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.

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

  28. 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.

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

  29. 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.

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

  30. 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.

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

  31. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2019
  2. Study start22 Jan 2019
  3. Primary completion17 Jun 2020
  4. Study completion17 Jun 2020

Why it stopped: COVID-19 disrupted interventions irrecoverably.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03945331
Sponsor's protocol ID
18-011086
Acronym
TransEpi
Status last verified
Oct 2020
First submitted
28 Apr 2019
Last updated
19 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Transcutaneous spinal cord stimulator and Epidural spinal cord stimulation system in people with Paraplegia, Spinal and Paraplegia, Complete, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: COVID-19 disrupted interventions irrecoverably.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Kinematics (time frame: Baseline, Month 3, Month 6, End of Month 7, Month 10, Month 13). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03945331.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.

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