Spinal Cord InjuriesE-STANDNCT03026816
Epidural Stimulation After Neurologic Damage
A study testing Epidural Spinal Cord Stimulation in people with Spinal Cord Injuries and Paraplegia, Complete, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Spinal Cord Injuries, Paraplegia, Complete
- What is being tested?
- Epidural Spinal Cord Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2017to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
David Darrow, MD MPH, 612-217-4290, estand@umn.edu
Study Coordinator, 612-873-9113, estand@umn.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Spinal Cord Injuries, Paraplegia, Complete
- Being tested
- Epidural Spinal Cord Stimulation
- Keywords
- epidural stimulation, spinal cord stimulation, autonomic dysfunction
- Medical subject headings
- Spinal Cord Injuries, Paraplegia, Primary Dysautonomias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural Spinal Cord StimulationDevice
epidural spinal cord stimulator
| Study group | Role | What they receive |
|---|---|---|
| Epidural Spinal Cord Stimulation | Experimental | Epidural Spinal Cord Stimulation Receives: Device: Epidural Spinal Cord Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Volitional Response Index Magnitude
Brain Motor Control Assessment Volitional Response Index Magnitude
Measured: Months: 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15
Secondary outcomes (4)
Spinal cord stimulation for cardiovascular function
Systolic blood pressure measured during epidural stimulation (continuous)
Measured: Over 12 months
Cerebrovascular Assessment Change
Cerebral blood flow (CBF) during tilt table
Measured: Months: 3, 6, 9
Change in Visual Neurocognitive Assessment
Stroop Test
Measured: Months: 3, 6, 9
Spinal cord stimulation optimization
Probit preference response surface obtained by serial force binary choice
Measured: Over 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study start7 Aug 2017
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Minnesota Office of Higher Education, Hennepin Healthcare Research Institute, Hennepin County Medical Center, Minneapolis
- Responsible party
- Sponsor
- Investigators
- David Darrow, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03026816
- Sponsor's protocol ID
- NEUROSURG-2017-25478
- Acronym
- E-STAND
- Status last verified
- Apr 2026
- First submitted
- 1 Jan 2017
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Shackleton C, Samejima S, Miller T, Sachdeva R, Parr A, Samadani U, Netoff T, Hocaloski S, Elliott S, Walter M, Darrow D, Krassioukov A. Effect of epidural spinal cord stimulation on female sexual function after spinal cord injury. Front Neurosci. 2023 Apr 5;17:1155796. doi: 10.3389/fnins.2023.1155796. eCollection 2023.
PubMed 37179555Hoover C, Schuerger W, Balser D, McCracken P, Murray TA, Morse L, Parr A, Samadani U, Netoff TI, Darrow DP. Neuromodulation Through Spinal Cord Stimulation Restores Ability to Voluntarily Cycle After Motor Complete Paraplegia. J Neurotrauma. 2024 May;41(9-10):1163-1171. doi: 10.1089/neu.2022.0322. Epub 2023 Mar 22.
PubMed 36719784Hoglund BK, Zurn CA, Madden LR, Hoover C, Slopsema JP, Balser D, Parr A, Samadani U, Johnson MD, Netoff TI, Darrow DP. Mapping Spinal Cord Stimulation-Evoked Muscle Responses in Patients With Chronic Spinal Cord Injury. Neuromodulation. 2023 Oct;26(7):1371-1380. doi: 10.1016/j.neurom.2022.10.058. Epub 2022 Dec 12.
PubMed 36517395Darrow 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.
PubMed 35851008Pena 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.
PubMed 32714156
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidural Stimulation for Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03026816
- Acronym / sponsor ID
- E-STAND / NEUROSURG-2017-25478
- Conditions
- Spinal Cord Injuries, Paraplegia, Complete
- Keywords
- epidural stimulation, spinal cord stimulation, autonomic dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Minnesota Office of Higher Education, Hennepin Healthcare Research Institute, Hennepin County Medical Center, Minneapolis
- Study start
- 7 Aug 2017 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 20 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Epidural Spinal Cord Stimulation | Experimental | Device: Epidural Spinal Cord StimulationEpidural Spinal Cord Stimulation |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural Spinal Cord Stimulationepidural spinal cord stimulator | Device | Epidural Spinal Cord Stimulation |
Primary outcome
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
4 secondary outcomes
Spinal cord stimulation for cardiovascular function
Time frame: Over 12 months
Cerebrovascular Assessment Change
Time frame: Months: 3, 6, 9
Change in Visual Neurocognitive Assessment
Time frame: Months: 3, 6, 9
Spinal cord stimulation optimization
Time frame: Over 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Derived from this study: PubMed 37179555Shackleton C, Samejima S, Miller T, Sachdeva R, Parr A, Samadani U, Netoff T, Hocaloski S, Elliott S, Walter M, Darrow D, Krassioukov A. Effect of epidural spinal cord stimulation on female sexual function after spinal cord injury. Front Neurosci. 2023 Apr 5;17:1155796. doi: 10.3389/fnins.2023.1155796. eCollection 2023.
- Derived from this study: PubMed 36719784Hoover C, Schuerger W, Balser D, McCracken P, Murray TA, Morse L, Parr A, Samadani U, Netoff TI, Darrow DP. Neuromodulation Through Spinal Cord Stimulation Restores Ability to Voluntarily Cycle After Motor Complete Paraplegia. J Neurotrauma. 2024 May;41(9-10):1163-1171. doi: 10.1089/neu.2022.0322. Epub 2023 Mar 22.
- Derived from this study: PubMed 36517395Hoglund BK, Zurn CA, Madden LR, Hoover C, Slopsema JP, Balser D, Parr A, Samadani U, Johnson MD, Netoff TI, Darrow DP. Mapping Spinal Cord Stimulation-Evoked Muscle Responses in Patients With Chronic Spinal Cord Injury. Neuromodulation. 2023 Oct;26(7):1371-1380. doi: 10.1016/j.neurom.2022.10.058. Epub 2022 Dec 12.
- Derived from this study: PubMed 35851008Darrow 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.
- Derived from this study: PubMed 32714156Pena 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.
- Clinical Trial WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Darrow, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural Spinal Cord Stimulation in people with Spinal Cord Injuries and Paraplegia, Complete, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (612-873-9113, estand@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Volitional Response Index Magnitude (time frame: Months: 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03026816, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.