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Spinal Cord Injury Epidural Stimulation

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ClinicalTrials.gov Identifier: NCT02592668
Recruitment Status : Active, not recruiting
First Posted : October 30, 2015
Last Update Posted : June 13, 2019
Sponsor:
Collaborators:
University of California, Los Angeles
Reneu Health Inc.
Bel13ve in Miracles Foundation
The Craig H. Neilsen Foundation
National Center for Advancing Translational Science (NCATS)
Information provided by (Responsible Party):
Kendall H. Lee, Mayo Clinic

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.


Condition or disease Intervention/treatment Phase
Spinal Cord Injury Device: Epidural Stimulator Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility Study: Epidural Stimulation to Enable Volitional Movement After Chronic Complete Paralysis in Humans.
Actual Study Start Date : February 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active stimulation
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
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 Name: Medtronic Restore ULTRA 97712




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02592668


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
University of California, Los Angeles
Reneu Health Inc.
Bel13ve in Miracles Foundation
The Craig H. Neilsen Foundation
National Center for Advancing Translational Science (NCATS)
Investigators
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Principal Investigator: Kendall Lee, MD, PhD Mayo Clinic

Additional Information:
Publications:
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Responsible Party: Kendall H. Lee, Kendall H. Lee, M.D., Ph.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT02592668     History of Changes
Other Study ID Numbers: 15-000510
UL1TR000135 ( U.S. NIH Grant/Contract )
First Posted: October 30, 2015    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System