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Epidural Stimulation After Neurologic Damage (E-STAND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03026816
Recruitment Status : Recruiting
First Posted : January 20, 2017
Last Update Posted : May 9, 2023
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Paraplegia, Complete Device: Epidural Spinal Cord Stimulation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
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
Official Title: Epidural Stimulation for Spinal Cord Injury
Actual Study Start Date : August 7, 2017
Estimated Primary Completion Date : January 2027
Estimated Study Completion Date : January 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Epidural Spinal Cord Stimulation
Epidural Spinal Cord Stimulation
 Device: Epidural Spinal Cord Stimulation
epidural spinal cord stimulator


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Spinal cord stimulation for cardiovascular function [ Time Frame: Over 12 months ]
    Systolic blood pressure measured during epidural stimulation (continuous)

  2. Cerebrovascular Assessment Change [ Time Frame: Months: 3, 6, 9 ]
    Cerebral blood flow (CBF) during tilt table

  3. Change in Visual Neurocognitive Assessment [ Time Frame: Months: 3, 6, 9 ]
    Stroop Test

  4. Spinal cord stimulation optimization [ Time Frame: Over 12 months ]
    Probit preference response surface obtained by serial force binary choice


Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT03026816


Contacts
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Contact: Study Coordinator 612-873-9113 estand@umn.edu
Contact: David Darrow, MD MPH 612-217-4290 estand@umn.edu

Locations
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United States, Minnesota
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: David Darrow, MD MPH    612-217-4290    estand@umn.edu   
Contact: Study Coordinator    612-873-9113    estand@umn.edu   
Principal Investigator: David Darrow, MD MPH         
Sponsors and Collaborators
University of Minnesota
Minnesota Office of Higher Education
Minneapolis Veterans Affairs Medical Center
Hennepin Healthcare Research Institute
Hennepin County Medical Center, Minneapolis
Investigators
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Principal Investigator: David Darrow, MD University of Minnesota
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03026816    
Other Study ID Numbers: NEUROSURG-2017-25478
First Posted: January 20, 2017    Key Record Dates
Last Update Posted: May 9, 2023
Last Verified: May 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by University of Minnesota:
epidural stimulation
spinal cord stimulation
autonomic dysfunction
Additional relevant MeSH terms:
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Spinal Cord Injuries
Paraplegia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
 Trauma, Nervous System
Wounds and Injuries
Paralysis
Neurologic Manifestations