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

NCT03945331 | Terminated FDA Device

• 1 other identifier: 18-011086
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Paraplegia, Spinal; Paraplegia, Complete; Paraplegia; Traumatic

Outcome Measures

Primary Outcomes (8)

• Kinematics

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

  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.

  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.

  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.

  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.

  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.

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

• Trunk stability

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

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

• 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.

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

Secondary Outcomes (31)

• Bowel function

  Baseline, Month 6, Month 13

• Bladder function

  Baseline, Month 6, Month 13

• Spasticity

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

• Bone mineral density

  Baseline, Month 6, Month 13

• Body composition - body fat mass

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

Other Outcomes (11)

• Volitional movement (1)

  1 year

• Volitional movement (2)

  1 year

• Volitional movement (3)

  1 year

Study Arms (2)

TESS

EXPERIMENTAL

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

Device: Transcutaneous spinal cord stimulator

EES

EXPERIMENTAL

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

Device: Transcutaneous spinal cord stimulator; Device: Epidural spinal cord stimulation system

Interventions

Transcutaneous spinal cord stimulator DEVICE

DS8R Electrical Stimulator For Human Research

EES; TESS

Epidural spinal cord stimulation system DEVICE

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

EES

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Minnesota Office of Higher Education: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Paraplegia

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kristin D. Zhao, Ph.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 28, 2019
• First Posted: May 10, 2019
• Study Start: January 22, 2019
• Primary Completion: June 17, 2020
• Study Completion: June 17, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)