Spinal Cord Injury Epidural Stimulation

NCT02592668 | Completed FDA Device

• 2 other identifiers: 15-000510UL1TR000135
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This is a feasibility study to test the use of epidural stimulation to restore volitional function previously lost due to spinal cord injury. Previous studies conducted in animal models, performed elsewhere and here at Mayo Clinic, have shown that direct electrical stimulation of the spinal cord increases the excitability of spared neuronal connections within the site of injury, thereby enhancing signal transmission and allowing recovery of previously lost volitional function. Recently, epidural electrical stimulation of the lumbosacral spinal cord in four individuals with spinal cord injury (SCI) has restored motor and autonomic function below the level of injury. Despite positive results, further translational research is needed to validate these findings. The goal of this proposal is to perform epidural stimulation to restore volitional function in patients with SCI. In two patients, we will implant an epidural stimulator onto the dorsal aspect of the lumbosacral spinal cord dura mater. Patients will undergo a structured program of daily physical rehabilitation, treadmill step training, and epidural stimulation to recover motor, sensory, and autonomic function.

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (4)

• Duration of time for which subject can sit unassisted on the edge of a mat table

  Approximately 50 weeks after implantation

• Assessment of volitional movement of lower limbs

  Approximately 50 weeks after implantation

• Subject's ability to coordinate stepping on a treadmill will be measured using biomechanical and electrophysiological analyses

  Approximately 50 weeks after implantation

• Duration of time for which subject can stand weight bearing with minimal assistance provided as needed.

  Approximately 50 weeks after implantation

Secondary Outcomes (12)

• Change in volitional movement restoration via NeuroRecovery scale

  baseline, approximately 50 weeks after implantation

• Change of bladder function, as measured by the Neurogenic Bladder Symptom Score questionnaire

  baseline, approximately 50 weeks after implantation

• Change in sexual function as measured by the Sexual Function Questionnaire

  baseline, approximately 50 weeks after implantation

• Change in body thermoregulatory capacity as measured by thermoregulatory sweat testing

  baseline, approximately 50 weeks after implantation

• Change in lean body mass

  baseline, approximately 50 weeks after implantation

Study Arms (1)

Active stimulation

EXPERIMENTAL

Subjects will be implanted with an epidural stimulator onto the dorsal aspect of the lumbosacral spinal cord dura mater. Patients will undergo a structured program of daily physical rehabilitation, treadmill step training, and epidural stimulation to recover motor, sensory, and autonomic function. The total estimated time for the intervention is 66 weeks.

Device: Epidural Stimulator

Interventions

Epidural Stimulator DEVICE

Subjects will be implanted with an epidural stimulator onto the dorsal aspect of the lumbosacral spinal cord dura mater. Patients will undergo a structured program of daily physical rehabilitation, treadmill step training, and epidural stimulation to recover motor, sensory, and autonomic function.

Also known as: Medtronic Restore ULTRA 97712

Active stimulation

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stable medical condition without \*cardiopulmonary disease or \*dysautonomia that would contraindicate standing or stepping with body weight support training
• No current anti-spasticity medication regimen
• Non-progressive spinal cord injury between the vertebral levels of C7 \& T10
• American Spinal Injury Association grading scale of A or B
• Sensory evoked potentials are either not present or have a bilateral delay
• Segmental reflexes remain functional below the lesion
• At least 2-years post-injury.

You may not qualify if:

• Pregnancy at time of enrollment
• Failure to obtain consent
• Prisoners
• Children (age less than 21)
• Any patient identified as unsuitable for this protocol by the Mayo study team
• Skeletal fracture
• Osteoporosis with Dual-energy X-ray absorptiometry (DEXA) t score ≤-3.5
• Uncontrolled urinary tract infections
• Presence or history of frequent decubitus ulcers
• Clinical depression
• Drug abuse
• Painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection that might interfere with stand or step training
• Current anti-spasticity medication regimen
• Voluntary motor response present in leg muscles
• Volitional control during voluntary movement attempts in leg muscles as measured by electromyography (EMG) activity

Sponsors & Collaborators

• Mayo Clinic: lead
• University of California, Los Angeles: collaborator
• Reneu Health Inc.: collaborator
• Bel13ve in Miracles Foundation: collaborator
• The Craig H. Neilsen Foundation: collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (4)

• Grahn PJ, Lavrov IA, Sayenko DG, Van Straaten MG, Gill ML, Strommen JA, Calvert JS, Drubach DI, Beck LA, Linde MB, Thoreson AR, Lopez C, Mendez AA, Gad PN, Gerasimenko YP, Edgerton VR, Zhao KD, Lee KH. Enabling Task-Specific Volitional Motor Functions via Spinal Cord Neuromodulation in a Human With Paraplegia. Mayo Clin Proc. 2017 Apr;92(4):544-554. doi: 10.1016/j.mayocp.2017.02.014.

  PMID: 28385196 BACKGROUND

• Gill ML, Grahn PJ, Calvert JS, Linde MB, Lavrov IA, Strommen JA, Beck LA, Sayenko DG, Van Straaten MG, Drubach DI, Veith DD, Thoreson AR, Lopez C, Gerasimenko YP, Edgerton VR, Lee KH, Zhao KD. Neuromodulation of lumbosacral spinal networks enables independent stepping after complete paraplegia. Nat Med. 2018 Nov;24(11):1677-1682. doi: 10.1038/s41591-018-0175-7. Epub 2018 Sep 24.

  PMID: 30250140 BACKGROUND

• Calvert JS, Grahn PJ, Strommen JA, Lavrov IA, Beck LA, Gill ML, Linde MB, Brown DA, Van Straaten MG, Veith DD, Lopez C, Sayenko DG, Gerasimenko YP, Edgerton VR, Zhao KD, Lee KH. Electrophysiological Guidance of Epidural Electrode Array Implantation over the Human Lumbosacral Spinal Cord to Enable Motor Function after Chronic Paralysis. J Neurotrauma. 2019 May 1;36(9):1451-1460. doi: 10.1089/neu.2018.5921. Epub 2018 Dec 15.

  PMID: 30430902 BACKGROUND

• Gill ML, Linde MB, Hale RF, Lopez C, Fautsch KJ, Calvert JS, Veith DD, Beck LA, Garlanger KL, Sayenko DG, Lavrov IA, Thoreson AR, Grahn PJ, Zhao KD. Alterations of Spinal Epidural Stimulation-Enabled Stepping by Descending Intentional Motor Commands and Proprioceptive Inputs in Humans With Spinal Cord Injury. Front Syst Neurosci. 2021 Jan 28;14:590231. doi: 10.3389/fnsys.2020.590231. eCollection 2020.

  PMID: 33584209 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Kristin D. Zhao, Ph.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kristin D. Zhao, Ph.D.

Study Record Dates

• First Submitted: October 22, 2015
• First Posted: October 30, 2015
• Study Start: January 4, 2016
• Primary Completion: September 14, 2018
• Study Completion: February 11, 2019
• Last Updated: April 13, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)