Epidural Stimulation After Neurologic Damage (E-STAND)
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ClinicalTrials.gov Identifier: NCT03026816 |
Recruitment Status :
Recruiting
First Posted : January 20, 2017
Last Update Posted : May 9, 2023
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Condition or disease | Intervention/treatment | Phase |
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Spinal Cord Injuries Paraplegia, Complete | Device: Epidural Spinal Cord Stimulation | Not Applicable |
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 (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 |

Arm | Intervention/treatment |
---|---|
Experimental: Epidural Spinal Cord Stimulation
Epidural Spinal Cord Stimulation
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Device: Epidural Spinal Cord Stimulation
epidural spinal cord stimulator |
- 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
- Spinal cord stimulation for cardiovascular function [ Time Frame: Over 12 months ]Systolic blood pressure measured during epidural stimulation (continuous)
- Cerebrovascular Assessment Change [ Time Frame: Months: 3, 6, 9 ]Cerebral blood flow (CBF) during tilt table
- Change in Visual Neurocognitive Assessment [ Time Frame: Months: 3, 6, 9 ]Stroop Test
- Spinal cord stimulation optimization [ Time Frame: Over 12 months ]Probit preference response surface obtained by serial force binary choice

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

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
Contact: Study Coordinator | 612-873-9113 | estand@umn.edu | |
Contact: David Darrow, MD MPH | 612-217-4290 | estand@umn.edu |
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 |
Principal Investigator: | David Darrow, MD | University of Minnesota |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
epidural stimulation spinal cord stimulation autonomic dysfunction |
Spinal Cord Injuries Paraplegia Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases |
Trauma, Nervous System Wounds and Injuries Paralysis Neurologic Manifestations |