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Completed

NCT Number: NCT02592668

Spinal Cord Injury Epidural Stimulation

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.

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • Brain influence on spinal reflexes as measured by EMG activity
  • Recordable motor evoked potential in the lower limbs with transcranial magnetic stimulation
  • Implanted cardiac pacemaker
  • Implanted defibrillator
  • Other implanted metallic or active body worn medical electronic device such as an insulin pump
  • *Cardiopulmonary disease that would result in exclusion from the study will be defined as clinically diagnosed chronic obstructive pulmonary disease, cardiac failure, and heart arrhythmia that would contraindicate sudden changes in body position such as sit-to-stand and stepping
  • *Excessive and uncontrolled autonomic dysreflexia characterized by symptomatic hypotension, light headedness and hypertension, flushing and bradycardia. Additionally blood pressure monitoring will be available at all times during rehabilitation and assessment times.

Treatment and study plan

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.

Other names: Medtronic Restore ULTRA 97712

Primary outcomes

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

    Time frame: Approximately 50 weeks after implantation

  2. Assessment of volitional movement of lower limbs

    Time frame: Approximately 50 weeks after implantation

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

    Time frame: Approximately 50 weeks after implantation

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

    Time frame: Approximately 50 weeks after implantation

Secondary outcomes

  1. Change in volitional movement restoration via NeuroRecovery scale

    Time frame: baseline, approximately 50 weeks after implantation

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

    Time frame: baseline, approximately 50 weeks after implantation

  3. Change in sexual function as measured by the Sexual Function Questionnaire

    Time frame: baseline, approximately 50 weeks after implantation

  4. Change in body thermoregulatory capacity as measured by thermoregulatory sweat testing

    Time frame: baseline, approximately 50 weeks after implantation

  5. Change in lean body mass

    Time frame: baseline, approximately 50 weeks after implantation

  6. Change in bone density

    Time frame: baseline, approximately 50 weeks after implantation

  7. Change in sense of wellbeing as measured by the World Health Organization Quality of Life (WHOQOL-BREF) questionnaire

    Time frame: baseline, approximately 50 weeks after implantation

  8. Change in sitting balance via functional reach test

    Time frame: baseline, approximately 50 weeks after implantation

  9. Change in spasticity via Ashworth spasticity test

    Time frame: baseline, approximately 50 weeks after implantation

  10. Change in ability of performing basic activities of daily life via spinal cord independence measure

    Time frame: baseline, approximately 50 weeks after implantation

  11. Change in total body fat

    Time frame: baseline, approximately 50 weeks after implantation

  12. Change in bowel function as measured by the Neurogenic Bowel Dysfunction Score questionnaire

    Time frame: baseline, approximately 50 weeks after implantation

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

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

Registry information

Official study title

A Feasibility Study: Epidural Stimulation to Enable Volitional Movement After Chronic Complete Paralysis in Humans.

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Oct 30, 2015
Registry last updated
Apr 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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