Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury

NCT04736849 | Completed Results DMC FDA Device

• 2 other identifiers: 20-0061041R01NS115877-01
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Paraplegia; Tetraplegia; Paralysis

Outcome Measures

Primary Outcomes (7)

• Electromyography

  Percent change in EMG voltage from beginning to end of intervention, recorded from the rectus femoris, during epidural and dorsal root spinal stimulation.

  Assessed at Day 1 (beginning of intervention) and Day 10 (end of intervention).

• Foot Pressure

  Measurements of foot pressure from shoe-insole sensors during no-stimulation bilaterally assisted standing and unassisted standing with stimulation.

  Assessed at Day 10 (end of intervention).

• Somatosensory Evoked Potentials

  Change from baseline to end of study, in amplitude of evoked potentials recorded from sensory cortex using skin surface electrodes during electrical stimulation of the right and left tibial nerve.

  Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).

• Transcranial Magnetic Stimulation Motor Evoked Potentials

  Change in intensity of stimulation, reported as percentage (0% to 100%) of maximum system output, required to elicit motor-evoked potentials below the level of injury.

  Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).

• American Spinal Injury Association Grading Scale

  Severity of spinal cord injury impairment will be assessed at baseline and end of study to examine changes in impairment that may be associated with the intervention.

  Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).

• Spasticity

  Change in measurements of spasticity using the Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET). Answers to qualitative questions are rated from -3 to +3, with a higher positive number indicating more helpful symptoms, and a lower negative number indicating more problematic symptoms. Questions may also be answered as not applicable (N/A), which do not generate a score. Scores are totaled for a score which categorizes the overall positive or negative impact of a subject's spasticity symptoms. Total score can range from -105 (negative impact) to +105 (positive impact), and the score is averaged by total positive or negative score divided by the number of applicable answers.

  Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).

• Modified Functional Reach Test

  On Day 10 (end of intervention), trunk balance was assessed with and without stimulation during attempts to reach forward using the modified functional reach test.

  Assessed at Day 10 (end of intervention).

Secondary Outcomes (5)

• Patient-reported Bowel Function

  Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).

• Patient-reported Bladder Function

  Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).

• Male Patient-reported Sexual Function (SHIM)

  Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).

• Male Patient-reported Sexual Function (IEF)

  Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).

• Neurostimulation User Experience

  Assessed at end of study ( after day 10 of intervention).

Study Arms (1)

Percutaneous ES and DRS

EXPERIMENTAL

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.

Device: Percutaneous epidural and dorsal root stimulation

Interventions

Percutaneous epidural and dorsal root stimulation 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

Percutaneous ES and DRS

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peter J. Grahn, Ph.D.: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic-Clinical Trials

MeSH Terms

Conditions

Spinal Cord Injuries; Paraplegia; Quadriplegia; Paralysis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Peter J. Grahn
• Organization: Mayo Clinic

Grahn.peter@mayo.edu

507-316-5556

Study Officials

• Peter J. Grahn, Ph.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: December 18, 2020
• First Posted: February 3, 2021
• Study Start: September 24, 2021
• Primary Completion: March 19, 2025
• Study Completion: March 19, 2025
• Last Updated: July 16, 2026
• Results First Posted: July 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)