Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury

NCT ID: NCT04736849

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-24
• Study Completion Date: 2025-03-19

Brief Summary

A study to compare electrophysiologic activity of epidural stimulation and dorsal root ganglion stimulation, as well as quantify changes in motor performance with both types of stimulation over the course of 10 rehabilitation sessions.

Detailed Description

This study aims to expand the understanding of how electrical spinal stimulation enables function, specifically the pathophysiological mechanisms of action underlying spinal electrical stimulation after SCI, and to address the gap in knowledge of spinal sensorimotor network inputs and outputs generated by spinal electrical stimulation in humans with SCI.

Conditions

Spinal Cord Injuries; Paraplegia; Tetraplegia; Paralysis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Percutaneous ES and DRS

Epidural Stimulation (ES) and Dorsal Root Stimulation (DRS) will be delivered via percutaneously implanted electrodes during rehabilitation. All implanted electrodes will be removed at the end of trial participation. The effects of ES and DRS will be recorded via electrophysiological and biomechanical metrics described within the outcomes measures.

Group Type: EXPERIMENTAL

Percutaneous epidural and dorsal root stimulation

Intervention Type: DEVICE

Abbott percutaneous trial lead for dorsal root ganglion neurostimulation (Model MN10350)

Abbott percutaneous trial lead for epidural neurostimulation (Model 3086)

Abbott clinician programmer for epidural and dorsal root ganglion neurostimulation (Model 3874)

Ripple Neuromed Nomad Neurostimulation System

Interventions

Percutaneous epidural and dorsal root stimulation

Abbott percutaneous trial lead for dorsal root ganglion neurostimulation (Model MN10350)

Abbott percutaneous trial lead for epidural neurostimulation (Model 3086)

Abbott clinician programmer for epidural and dorsal root ganglion neurostimulation (Model 3874)

Ripple Neuromed Nomad Neurostimulation System

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Spinal cord injury due to trauma located at or above the tenth thoracic vertebrae
• American Spinal Injury Association grading scale of A, B, C, or D
• Intact spinal reflexes below the level of SCI
• SCI must have occurred at least 1 year prior to study enrollment
• At least 22 years of age
• If female, must be willing to use medically-acceptable method of contraception during study participation

Exclusion Criteria

• Currently a prison inmate, or awaiting trial, related to criminal activity
• Pregnancy at the time of screening for trial enrollment
• Active, untreated urinary tract infection
• Unhealed decubitus ulcer
• Unhealed skeletal fracture
• Spinal abnormality that may impede percutaneous implantation of spinal electrodes
• Untreated clinical diagnosis of psychiatric disorder
• Joint contractures that impede typical range of motion
• Non-MRI-compatible implanted medical devices
• Other implanted stimulation devices (e.g. deep brain stimulator, cardiac pacemaker, diaphragmatic pacer, etc.)
• Undergoing, or planning to undergo, diathermy treatment
• Active participation in an interventional clinical trial
• History of clinically-diagnosed cardiopulmonary disorder, such as severe orthostatic hypotension, which may impede participation in rehabilitation activities such as changes in body position such as supine-to-sit-to-stand activities, prolonged standing, or stepping
• History of frequent and/or severe autonomic dysreflexia
• History of seizure disorder
• 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

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

Peter J. Grahn, Ph.D.

OTHER

Sponsor Role: lead

Responsible Party

Peter J. Grahn, Ph.D.

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Peter J. Grahn, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Related Links

https://clinicaltrials.gov/study/NCT04736849

Mayo Clinic-Clinical Trials

Other Identifiers

1R01NS115877-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-006104

Identifier Type: -

Identifier Source: org_study_id