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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-22

Study Completion Date

2020-06-17

Brief Summary

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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.

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Detailed Description

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Conditions

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Paraplegia, Spinal Paraplegia, Complete Paraplegia; Traumatic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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TESS

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

Group Type EXPERIMENTAL

Transcutaneous spinal cord stimulator

Intervention Type DEVICE

DS8R Electrical Stimulator For Human Research

EES

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

Group Type EXPERIMENTAL

Transcutaneous spinal cord stimulator

Intervention Type DEVICE

DS8R Electrical Stimulator For Human Research

Epidural spinal cord stimulation system

Intervention Type DEVICE

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

Interventions

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Transcutaneous spinal cord stimulator

DS8R Electrical Stimulator For Human Research

Intervention Type DEVICE

Epidural spinal cord stimulation system

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No