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Epidural Stimulation After Neurologic Damage (E-STAND)

This study is currently recruiting participants.
Verified August 2017 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT03026816
First Posted: January 20, 2017
Last Update Posted: August 14, 2017
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.
Collaborators:
Minnesota Office of Higher Education
Minneapolis VA Health Care System
Minneapolis Medical Research Foundation
Hennepin County Medical Center, Minneapolis
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
  Purpose
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 Intervention
Spinal Cord Injuries Paraplegia, Complete Device: Epidural Spinal Cord Stimulation

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • 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:
  • 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 ]
    A test of the sympathetic nervous system using a reflex sweat response

  • Blood pressure [ Time Frame: Months: 3, 6, 9 ]
    Blood pressure measured during epidural stimulation

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

  • Change in Arterial Stiffness [ Time Frame: Months: 3, 6, 9 ]
    Measurement of velocity and wall thickness of carotid arteries

  • 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


Estimated Enrollment: 100
Actual Study Start Date: August 7, 2017
Estimated Study Completion Date: January 2023
Estimated Primary Completion Date: January 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Epidural Spinal Cord Stimulation
Epidural Spinal Cord Stimulation
Device: Epidural Spinal Cord Stimulation
epidural spinal cord stimulator

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   22 Years and older   (Adult, Senior)
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
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
Contact: David Y Balser, MD 612-873-7190 estand@umn.edu
Contact: David Darrow, MD MPH 612-217-4290 estand@umn.edu

Locations
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: David Y Balser, MD    612-873-7190    estand@umn.edu   
Principal Investigator: David Darrow, MD MPH         
Sub-Investigator: Uzma Samadani, MD PhD         
Sub-Investigator: David Balser, MD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Minnesota Office of Higher Education
Minneapolis VA Health Care System
Minneapolis Medical Research Foundation
Hennepin County Medical Center, Minneapolis
Investigators
Principal Investigator: David Darrow, MD University of Minnesota - Clinical and Translational Science Institute
  Study Documents (Full-Text)

Documents provided by University of Minnesota - Clinical and Translational Science Institute:
  More Information

Additional Information:
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03026816     History of Changes
Other Study ID Numbers: 16-4115
First Submitted: January 1, 2017
First Posted: January 20, 2017
Last Update Posted: August 14, 2017
Last Verified: August 2017

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

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
epidural stimulation
spinal cord stimulation
autonomic dysfunction

Additional relevant MeSH terms:
Spinal Cord Injuries
Paraplegia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Paralysis
Neurologic Manifestations
Signs and Symptoms