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Epidural Stimulation After Neurologic Damage (E-STAND)

Primary Purpose

Spinal Cord Injuries, Paraplegia, Complete

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Epidural Spinal Cord Stimulation
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring epidural stimulation, spinal cord stimulation, autonomic dysfunction

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hennepin County Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Epidural Spinal Cord Stimulation

Arm Description

Epidural Spinal Cord Stimulation

Outcomes

Primary Outcome Measures

Change in Volitional Response Index Magnitude
Brain Motor Control Assessment Volitional Response Index Magnitude

Secondary Outcome Measures

Spinal cord stimulation for cardiovascular function
Systolic blood pressure measured during epidural stimulation (continuous)
Cerebrovascular Assessment Change
Cerebral blood flow (CBF) during tilt table
Change in Visual Neurocognitive Assessment
Stroop Test
Spinal cord stimulation optimization
Probit preference response surface obtained by serial force binary choice

Full Information

First Posted
January 1, 2017
Last Updated
May 8, 2023
Sponsor
University of Minnesota
Collaborators
Minnesota Office of Higher Education, Minneapolis Veterans Affairs Medical Center, Hennepin Healthcare Research Institute, Hennepin County Medical Center, Minneapolis
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1. Study Identification

Unique Protocol Identification Number
NCT03026816
Brief Title
Epidural Stimulation After Neurologic Damage
Acronym
E-STAND
Official Title
Epidural Stimulation for Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 7, 2017 (Actual)
Primary Completion Date
January 2027 (Anticipated)
Study Completion Date
January 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
Minnesota Office of Higher Education, Minneapolis Veterans Affairs Medical Center, Hennepin Healthcare Research Institute, Hennepin County Medical Center, Minneapolis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Paraplegia, Complete
Keywords
epidural stimulation, spinal cord stimulation, autonomic dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Epidural Spinal Cord Stimulation
Arm Type
Experimental
Arm Description
Epidural Spinal Cord Stimulation
Intervention Type
Device
Intervention Name(s)
Epidural Spinal Cord Stimulation
Intervention Description
epidural spinal cord stimulator
Primary Outcome Measure Information:
Title
Change in Volitional Response Index Magnitude
Description
Brain Motor Control Assessment Volitional Response Index Magnitude
Time Frame
Months: 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15
Secondary Outcome Measure Information:
Title
Spinal cord stimulation for cardiovascular function
Description
Systolic blood pressure measured during epidural stimulation (continuous)
Time Frame
Over 12 months
Title
Cerebrovascular Assessment Change
Description
Cerebral blood flow (CBF) during tilt table
Time Frame
Months: 3, 6, 9
Title
Change in Visual Neurocognitive Assessment
Description
Stroop Test
Time Frame
Months: 3, 6, 9
Title
Spinal cord stimulation optimization
Description
Probit preference response surface obtained by serial force binary choice
Time Frame
Over 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Coordinator
Phone
612-873-9113
Email
estand@umn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
David Darrow, MD MPH
Phone
612-217-4290
Email
estand@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Darrow, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Darrow, MD MPH
Phone
612-217-4290
Email
estand@umn.edu
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
612-873-9113
Email
estand@umn.edu
First Name & Middle Initial & Last Name & Degree
David Darrow, MD MPH

12. IPD Sharing Statement

Citations:
PubMed Identifier
35851008
Citation
Darrow DP, Balser DY, Freeman D, Pelrine E, Krassioukov A, Phillips A, Netoff T, Parr A, Samadani U. Effect of epidural spinal cord stimulation after chronic spinal cord injury on volitional movement and cardiovascular function: study protocol for the phase II open label controlled E-STAND trial. BMJ Open. 2022 Jul 18;12(7):e059126. doi: 10.1136/bmjopen-2021-059126.
Results Reference
derived
PubMed Identifier
32714156
Citation
Pena Pino I, Hoover C, Venkatesh S, Ahmadi A, Sturtevant D, Patrick N, Freeman D, Parr A, Samadani U, Balser D, Krassioukov A, Phillips A, Netoff TI, Darrow D. Long-Term Spinal Cord Stimulation After Chronic Complete Spinal Cord Injury Enables Volitional Movement in the Absence of Stimulation. Front Syst Neurosci. 2020 Jun 30;14:35. doi: 10.3389/fnsys.2020.00035. eCollection 2020.
Results Reference
derived
Links:
URL
http://www.estand.org
Description
Clinical Trial Website

Learn more about this trial

Epidural Stimulation After Neurologic Damage

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