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Epidural Stimulation After Neurologic Damage (E-STAND)

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ClinicalTrials.gov Identifier: NCT03026816
Recruitment Status : Recruiting
First Posted : January 20, 2017
Last Update Posted : May 13, 2019
Sponsor:
Collaborators:
Minnesota Office of Higher Education
Minneapolis Veterans Affairs Medical Center
Hennepin Healthcare Research Institute.
Hennepin County Medical Center, Minneapolis
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE January 1, 2017
First Posted Date  ICMJE January 20, 2017
Last Update Posted Date May 13, 2019
Actual Study Start Date  ICMJE August 7, 2017
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2017)
Change in Volitional Response Index Magnitude [ Time Frame: Months: 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 ]
Brain Motor Control Assessment Volitional Response Index Magnitude
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03026816 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2018)
  • Change in Blood pressure (Systolic and Diastolic) [ Time Frame: Over 12 months ]
    Blood pressure measured during epidural stimulation (continuous)
  • Cerebrovascular Assessment Change [ Time Frame: Months: 3, 6, 9 ]
    cerebral blood flow (CBF) during tilt table
  • Change in Visual Neurocognitive Assessment [ Time Frame: Months: 3, 6, 9 ]
    Stroop Test
  • Accelerometer investigation of Parameter Space [ Time Frame: Evaluated 1 hour of 4 days per week over 12 months ]
    wireless home accelerometer volitional movement detection system
  • Effect of SCS on urinary control [ Time Frame: Months: 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 ]
    subjective measures of urinary control
Original Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2017)
  • Change in Standing power [ Time Frame: Months: 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 ]
    Power generated during attempts at standing
  • Change in Sympathetic Skin Responses (SSR) [ Time Frame: Months: 3, 6, 9, 12, 15 ]
  • Blood pressure [ Time Frame: Months: 3, 6, 9, 12, 15 ]
    Blood pressure measured during epidural stimulation
  • Cerebrovascular Assessment Change [ Time Frame: Months: 3, 6, 9, 12, 15 ]
    cerebral blood flow (CBF) during tilt table
  • Change in Arterial Stiffness [ Time Frame: Months: 3, 6, 9, 12, 15 ]
  • Change in Visual Neurocognitive Assessment [ Time Frame: Months: 3, 6, 9, 12, 15 ]
    Stroop Test
  • Accelerometer investigation of Parameter Space [ Time Frame: Evaluated 1 hour of 4 days per week over 12 months ]
    wireless home accelerometer volitional movement detection system
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Epidural Stimulation After Neurologic Damage
Official Title  ICMJE Epidural Stimulation for Spinal Cord Injury
Brief Summary This study will evaluate a method to optimize parameter settings in epidural spinal cord stimulation used to recover lower extremity volitional movement. The study will also characterize improvement in autonomic function (such as blood pressure control) and other functions related to spinal cord injury.
Detailed Description

Epidural spinal cord stimulation for the purpose of facilitating volitional movement is a new and novel neuromodulatory treatment. Epidural SCS has a long history of use for chronic pain with established medical device platforms. The purpose of this study is to investigate and establish the use of SCS for volitional movement. Specifically, establishing the disinhibitory effect of SCS in a greater population with inherent greater variability.

In addition to establishing the disinhibitory effect of SCS for cSCI, our study attempts to explore the parameter space of the spinal cord stimulator platforms in order to optimize stimulation settings for patients through the creation of a clinical decision support system (CDSS). Preliminary evidence suggests benefit to autonomic function, and this study also begins to explore the effects of SCS on cardiovascular function, urinary function, psychiatric outcomes, and quality of life, which all offer significant potential for patients suffering from chronic spinal cord injury.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
All subjects will receive study intervention. Outcome assessments will be tested while the stimulator unit is on (intervention) and off (sham) during the study.
Masking: None (Open Label)
Masking Description:
Masking is done during formal testing of BMCA
Primary Purpose: Treatment
Condition  ICMJE
  • Spinal Cord Injuries
  • Paraplegia, Complete
Intervention  ICMJE Device: Epidural Spinal Cord Stimulation
epidural spinal cord stimulator
Study Arms  ICMJE Experimental: Epidural Spinal Cord Stimulation
Epidural Spinal Cord Stimulation
Intervention: Device: Epidural Spinal Cord Stimulation
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 17, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2023
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 22 years of age or older
  • Able to undergo the informed consent/assent process
  • Stable, motor-complete paraplegia
  • Discrete spinal cord injury between C6 and T10
  • ASIA A or B Spinal Cord Injury Classification
  • Medically stable in the judgement of the principal investigator
  • Intact segmental reflexes below the lesion of injury
  • Greater than 1 year since initial injury and at least 6 months from any required spinal instrumentation
  • Willing to attend all scheduled appointments

Exclusion Criteria:

  • Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery (e.g. cardiopulmonary issues)
  • Inability to withhold antiplatelet/anticoagulation agents perioperatively
  • Significant dysautonomia that would prohibit rehabilitation or assisted standing or any history of CVA or MI associated with autonomic dysreflexia. A single tilt table test with syncope, presyncope, or SBP < 50 or >200.
  • Other conditions that would make the subject unable to participate in testing/rehabilitation in the judgement of the principal investigator
  • Current and anticipated need for opioid pain medications or pain that would prevent full participation in the rehabilitation program in the judgement of the principal investigator
  • Clinically significant mental illness in the judgement of the principal investigator
  • Botulinum toxin injections in the previous 6 months
  • Volitional movements present during EMG testing in bilateral lower extremities
  • Unhealed spinal fracture
  • Presence of significant contracture
  • Presence of pressure ulcers
  • Recurrent urinary tract infection refractory to antibiotics
  • Current Pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: David Y Balser, MD 612-873-7190 estand@umn.edu
Contact: David Darrow, MD MPH 612-217-4290 estand@umn.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03026816
Other Study ID Numbers  ICMJE 16-4115
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 Not Provided
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE
  • Minnesota Office of Higher Education
  • Minneapolis Veterans Affairs Medical Center
  • Hennepin Healthcare Research Institute.
  • Hennepin County Medical Center, Minneapolis
Investigators  ICMJE
Principal Investigator: David Darrow, MD University of Minnesota
PRS Account University of Minnesota
Verification Date May 2019

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