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Epidural Stimulation After Neurologic Damage (E-STAND)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2017 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT03026816
First received: January 1, 2017
Last updated: April 19, 2017
Last verified: April 2017
  Purpose

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.


Condition Intervention Phase
Spinal Cord Injuries
Paraplegia, Complete
Device: Epidural Spinal Cord Stimulation
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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, 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


Estimated Enrollment: 100
Anticipated Study Start Date: April 28, 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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03026816

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: David Darrow, MD 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
Study First Received: January 1, 2017
Last Updated: April 19, 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

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

ClinicalTrials.gov processed this record on May 22, 2017