Short-Term Transcutaneous or Epidural Spinal Stimulation for Enabling Motor Function in Humans With SCI

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-04

Study Completion Date

2023-03-30

Brief Summary

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A study comparing short-term delivery of epidural spinal stimulation versus transcutaneous spinal stimulation.

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Detailed Description

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The purpose of this study is to compare spinal motor nerve response to electrical stimulation delivered directly to the epidural space, and delivered through the skin (transcutaneously), and to measure any changes in motor performance over the course of about 5 months, during and after using one of the two types of stimulation.

Conditions

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Paraplegia Tetraplegia Paralysis Quadraplegia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Percutaneous Epidural Stimulation

Epidural spinal stimulation will be delivered via percutaneously implanted electrodes during rehabilitation. All implanted electrodes will be removed at the end of trial participation. The effects of epidural stimulation will be recorded via electrophysiological and biomechanical metrics described within the outcomes measures.

Group Type EXPERIMENTAL

Percutaneous epidural electrical spinal stimulation

Intervention Type DEVICE

Abbott percutaneous trial lead for epidural neurostimulation (Model 3086)

Ripple Neuromed Nomad Neurostimulation System

Transcutaneous Epidural Stimulation

Transcutaneous spinal stimulation will be delivered via skin surface-level electrodes during rehabilitation. The effects of transcutaneous stimulation will be recorded via electrophysiological and biomechanical metrics described within the outcomes measures.

Group Type EXPERIMENTAL

Transcutaneous electrical spinal stimulation

Intervention Type DEVICE

Digitimer DS8R Bipolar Constant Current Stimulator

Interventions

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Percutaneous epidural electrical spinal stimulation

Abbott percutaneous trial lead for epidural neurostimulation (Model 3086)

Ripple Neuromed Nomad Neurostimulation System

Intervention Type DEVICE

Transcutaneous electrical spinal stimulation

Digitimer DS8R Bipolar Constant Current Stimulator

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Spinal cord injury due to trauma located at or above the tenth thoracic vertebrae (T10)
* American Spinal Injury Association grading scale of A-D (2 from each) 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
* History of chronic and/or treatment resistant urinary tract infection
* Unhealed decubitus ulcer
* Unhealed skeletal fracture
* Untreated clinical diagnosis of depression
* 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
* 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
* 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