Transcutaneous and Epidural Stimulation in SCI

NCT04627441 | Withdrawn FDA Device

• 1 other identifier: 20-006477
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Paraplegia, Spinal; Paraplegia, Complete; Paraplegia; Traumatic

Outcome Measures

Primary Outcomes (10)

• Kinematics

  Change in measurements of joint angles, measured in degrees.

  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.

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

• Foot pressure

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

  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.

  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.

  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.

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

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

• Monosynaptic spinal reflex testing

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

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

• Trunk stability

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

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

• Injury severity: American Spinal Injury Association (ASIA) Impairment Scale

  Change in measurements of impairment of sensory and motor functions using the American Spinal Injury Association Impairment Scale. 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 ASIA 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, End of TESS, Start of EES, End month 6 EES

Secondary Outcomes (23)

• Spasticity

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

• Bone mineral density

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

• Body composition - body fat mass

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

• Body composition - lean mass

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

• Body composition - android and gynoid fat percentage

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

Other Outcomes (11)

• Volitional movement (1)

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

• Volitional movement (2)

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

• Volitional movement (3)

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

Study Arms (1)

TESS-EES

EXPERIMENTAL

Transcutaneous Electrical Spinal Stimulation (TESS), used during the first month of training sessions, followed by Epidural Electrical Stimulation (EES) during the final 6-month training period.

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

Interventions

Transcutaneous spinal cord stimulator DEVICE

DS8R Electrical Stimulator For Human Research

TESS-EES

Epidural spinal cord stimulator system DEVICE

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

TESS-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 (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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kristin Zhao, PhD: lead

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: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: November 13, 2020
• Study Start: December 16, 2022
• Primary Completion: December 16, 2025
• Study Completion: December 16, 2025
• Last Updated: October 4, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share