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Trial record 3 of 26 for:    Injuries | Spinal Cord Injuries | ( Map: Minnesota, United States )

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

Tracking Information
First Submitted Date  ICMJE October 22, 2015
First Posted Date  ICMJE October 30, 2015
Last Update Posted Date June 13, 2019
Actual Study Start Date  ICMJE February 2016
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2018)
  • Duration of time for which subject can sit unassisted on the edge of a mat table [ Time Frame: Approximately 50 weeks after implantation ]
  • Assessment of volitional movement of lower limbs [ Time Frame: Approximately 50 weeks after implantation ]
  • Subject's ability to coordinate stepping on a treadmill will be measured using biomechanical and electrophysiological analyses [ Time Frame: Approximately 50 weeks after implantation ]
  • Duration of time for which subject can stand weight bearing with minimal assistance provided as needed. [ Time Frame: Approximately 50 weeks after implantation ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 29, 2015)
  • Duration of time for which subject can sit unassisted on the edge of a mat table [ Time Frame: Approximately 50 weeks after implantation ]
  • Assessment of volitional movement of lower limbs [ Time Frame: Approximately 50 weeks after implantation ]
  • Subject's ability to coordinate stepping on a treadmill will be measured using electromyographic analysis [ Time Frame: Approximately 50 weeks after implantation ]
  • Duration of time for which subject can stand with full weight bearing in a body-support system [ Time Frame: Approximately 50 weeks after implantation ]
Change History Complete list of historical versions of study NCT02592668 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2015)
  • Change in volitional movement restoration via NeuroRecovery scale [ Time Frame: baseline, approximately 50 weeks after implantation ]
  • Change of bladder function, as measured by the Neurogenic Bladder Symptom Score questionnaire [ Time Frame: baseline, approximately 50 weeks after implantation ]
  • Change in sexual function as measured by the Sexual Function Questionnaire [ Time Frame: baseline, approximately 50 weeks after implantation ]
  • Change in body thermoregulatory capacity as measured by thermoregulatory sweat testing [ Time Frame: baseline, approximately 50 weeks after implantation ]
  • Change in lean body mass [ Time Frame: baseline, approximately 50 weeks after implantation ]
  • Change in bone density [ Time Frame: baseline, approximately 50 weeks after implantation ]
  • 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 ]
  • Change in sitting balance via functional reach test [ Time Frame: baseline, approximately 50 weeks after implantation ]
  • Change in spasticity via Ashworth spasticity test [ Time Frame: baseline, approximately 50 weeks after implantation ]
  • Change in ability of performing basic activities of daily life via spinal cord independence measure [ Time Frame: baseline, approximately 50 weeks after implantation ]
  • Change in total body fat [ Time Frame: baseline, approximately 50 weeks after implantation ]
  • Change in bowel function as measured by the Neurogenic Bowel Dysfunction Score questionnaire [ Time Frame: baseline, approximately 50 weeks after implantation ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Spinal Cord Injury Epidural Stimulation
Official Title  ICMJE A Feasibility Study: Epidural Stimulation to Enable Volitional Movement After Chronic Complete Paralysis in Humans.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injury
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Device: Epidural Stimulator
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 29, 2015)
2
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02592668
Other Study ID Numbers  ICMJE 15-000510
UL1TR000135 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kendall H. Lee, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Kendall Lee, MD, PhD Mayo Clinic
PRS Account Mayo Clinic
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP