Epidural Stimulation After Neurologic Damage (E-STAND)

April 2, 2026 updated by: University of Minnesota

Epidural Stimulation for Spinal Cord Injury

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Study Coordinator
  • Phone Number: 612-873-9113
  • Email: estand@umn.edu

Study Contact Backup

  • Name: David Darrow, MD MPH
  • Phone Number: 612-217-4290
  • Email: estand@umn.edu

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Recruiting
        • Hennepin County Medical Center
        • Contact:
        • Contact:
          • David Darrow, MD MPH
          • Phone Number: 612-217-4290
          • Email: estand@umn.edu
        • Principal Investigator:
          • David Darrow, MD MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Epidural Spinal Cord Stimulation
Device: Epidural Spinal Cord Stimulation
epidural spinal cord stimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Months: 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spinal cord stimulation for cardiovascular function
Time Frame: Over 12 months
Systolic blood pressure measured during epidural stimulation (continuous)
Over 12 months
Cerebrovascular Assessment Change
Time Frame: Months: 3, 6, 9
Cerebral blood flow (CBF) during tilt table
Months: 3, 6, 9
Change in Visual Neurocognitive Assessment
Time Frame: Months: 3, 6, 9
Stroop Test
Months: 3, 6, 9
Spinal cord stimulation optimization
Time Frame: Over 12 months
Probit preference response surface obtained by serial force binary choice
Over 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Collaborators

Hennepin Healthcare Research Institute
Hennepin County Medical Center, Minneapolis
Minnesota Office of Higher Education

Investigators

  • Principal Investigator: David Darrow, MD, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2017

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

January 1, 2017

First Submitted That Met QC Criteria

January 17, 2017

First Posted (Estimated)

January 20, 2017

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEUROSURG-2017-25478

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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