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

Kristin Zhao, PhD

Status: Completed

Conditions: Tetraplegia; Quadraplegia; Paraplegia; Paralysis

Treatments: Device: Percutaneous epidural electrical spinal stimulation; Device: Transcutaneous electrical spinal stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05095454

21-006340

Details and patient eligibility

About

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

Full description

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.

Enrollment: 6 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

Percutaneous Epidural Stimulation

Experimental group

Description:

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.

Treatment:

Device: Percutaneous epidural electrical spinal stimulation

Transcutaneous Epidural Stimulation

Experimental group

Description:

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.

Treatment:

Device: Transcutaneous electrical spinal stimulation