Spinal Cord InjuryPhase 1/2NCT06410001
CE-STAND: Cervical Epidural STimulation After Neurologic Damage
A Phase 1/2 study testing Epidural Spinal Cord Stimulation System in people with Spinal Cord Injury, run by University of Minnesota at 1 site in United States.
Trial summary
CE-STAND aims to address three areas under-represented in research: chronic, cervical, and autonomic dysfunction. It is both significant and highly impactful, as treating autonomic dysfunction could substantially improve function and quality of life (QoL) in chronic cervical SCI patients. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Epidural Spinal Cord Stimulation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2026to 30 Jul 2030
- Phase
- Phase 1/2
- 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
- Twenty two years of age or older
- Able to undergo the informed consent/assent process
- Stable, motor-complete SCI
- Discrete SCI between C4 and C7 (upper extremity weakness)
- ASIA A or B SCI Classification
- Medically stable in the judgment of the PI
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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
- Normal or corrected-to-normal vision to accurately perceive visual stimuli on the N-back task screen, and sufficient hearing ability to accurately perceive auditory stimuli during the task
- Willing to attend all scheduled appointments
Who cannot join
- Diseases and conditions that would increase the morbidity and mortality of this surgery such as cardiopulmonary.
- Individuals who require respiratory support, including ongoing or intermittent use of a ventilator and/or diaphragmatic pacer
- Inability to withhold antiplatelet/anticoagulation agents perioperatively
- Individuals who have history of recurrent autonomic dysreflexia in the judgment of the PI
- Significant dysautonomia that would prohibit rehabilitation or any history of cerebrovascular accident or myocardial infarction associated with autonomic dysreflexia. A single tilt table test with syncope, presyncope, or SBP < 50 or > 200
- Failure to exhibit cardiovascular autonomic dysfunction on tilt table testing
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- Other conditions that would make the subject unable to participate in testing/rehabilitation in the judgment of the PI
- Patients who have participated in another study within the last 12 months in which they have received fluoroscopic or other related radiation exposure
- Current and anticipated need for opioid pain medications or pain that would prevent full participation in the program in the judgment of the PI
- Clinically significant mental illness in the judgment of the PI
- Treatment with botulinum toxin, intrathecal baclofen pump, and antispasmodics will not be permitted unless discussed with and approved by the study PI
- Patients with a history of significant depression or drug abuse
- Volitional movements present during EMG testing in bilateral lower extremities
- Unhealed spinal fracture
- Presence of significant contracture with loss of greater than two-thirds range of motion
- Presence of pressure ulcers
- 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.
Nadine Mansour, MD, MPH, PhD contact
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Ann Parr, MD, PhD, 612-625-4102, amparr@umn.edu
About this study
CE-STAND aims to address three areas under-represented in research: chronic, cervical, and autonomic dysfunction. It is both significant and highly impactful, as treating autonomic dysfunction could substantially improve function and quality of life (QoL) in chronic cervical SCI patients.
Read the detailed description
Spinal cord injury (SCI) affects over 18,000 individuals annually, leading to significant motor and autonomic dysfunctions that reduce quality of life (QoL). Epidural spinal cord stimulation (eSCS) has shown potential in restoring function in chronic individuals with SCI. However, research on cervical, and autonomic dysfunction-related SCI remains limited. This study will assess the safety and efficacy of eSCS in improving autonomic and volitional functions, as well as truncal stability, bowel, bladder, and sexual function, and overall QoL.
The study is a Phase I/II trial in which participants will serve as their own controls. The Abbott Eterna epidural stimulator system will be implanted, and assessments will occur every three months. The study will be conducted over a period of four years. A total of 36 participants will be enrolled and followed for one year.
Bayesian Optimization will be used to determine the most effective stimulation settings, with 15 settings programmed at the end of each visit.
FDA and UMN IRB approvals have been secured for the study. Interim reports will be made available through peer-reviewed journals, conference presentations, and clinical network reporting.
CE-STAND seeks to advance SCI treatment by expanding eSCS applications in chronic cervical SCI, improving patient outcomes, and reducing healthcare costs.
- Conditions
- Spinal Cord Injury
- Being tested
- Epidural Spinal Cord Stimulation System
- Keywords
- Cervical, Spinal cord injury, Epidural spinal cord stimulation, Autonomic dysfunction
- Medical subject headings
- Spinal Cord Injuries, Primary Dysautonomias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural Spinal Cord Stimulation SystemDevice
Abbott Eterna system implantable pulse generator (IPG), charger, and TriCentrus lead
| Study group | Role | What they receive |
|---|---|---|
| Spinal injury patients | Experimental | Experimental: Individuals with cervical SCI comparing stimulation "on" vs "off" longitudinally. Receives: Device: Epidural Spinal Cord Stimulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of epidural spinal cord stimulator in chronic cervical patients
Incidence of adverse events (AEs) and serious adverse events (SAEs) including hypotension, other hemodynamic instability, infection, bleeding, significant pain, spasticity, or cerebrospinal fluid leak.
Measured: 1 year
Secondary outcomes (5)
Changes in blood pressure
Measured on tilt table testing. Both systolic and diastolic pressure will be assessed
Measured: 1 year
Changes in heart rate
Measured on tilt table testing
Measured: 1 year
Cognitive function
Measured using N-back testing
Measured: 1 year
Cerebral blood flow
Measured using transcranial doppler
Measured: 1 year
Muscle Sympathetic Nerve Activities (MSNA)
Microneurolography
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start15 Mar 2026
- Primary completion31 May 2030 (estimated)
- Study completion30 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ann Parr, MD, PhD, Principal investigator, University of MinnesotaManda Keller-Ross, PhD, DPT, PT, Principal investigator, University of MinnesotaNadine Mansour, MD, MPH, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410001
- Sponsor's protocol ID
- NEUROSURG-2023-31800
- Status last verified
- Mar 2026
- First submitted
- 19 Apr 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified data will be deposited in the Data Repository for the University of Minnesota (DRUM), an open-access institutional repository. Data stored during the project will be maintained in Box Secure Storage and REDCap before long-term archiving in DRUM.
Publications
Mansour N, Keller-Ross M, Low W, Balser DY, Parr A. Effect of Cervical Epidural STimulation After Neurological Damage: protocol for phase I/II open label controlled CE-STAND trial. BMJ Open. 2026 Feb 12;16(2):e107661. doi: 10.1136/bmjopen-2025-107661.
PubMed 41688122
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CE-STAND: Cervical Epidural STimulation After Neurologic Damage
- ClinicalTrials.gov ID
- NCT06410001
- Acronym / sponsor ID
- NEUROSURG-2023-31800
- Conditions
- Spinal Cord Injury
- Keywords
- Cervical, Spinal cord injury, Epidural spinal cord stimulation, Autonomic dysfunction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- 31 May 2030 (estimated)
- Study completion
- 30 Jul 2030 (estimated)
- First posted
- 10 May 2024 (actual)
- 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.
CE-STAND aims to address three areas under-represented in research: chronic, cervical, and autonomic dysfunction. It is both significant and highly impactful, as treating autonomic dysfunction could substantially improve function and quality of life (QoL) in chronic cervical SCI patients.
Detailed description
Spinal cord injury (SCI) affects over 18,000 individuals annually, leading to significant motor and autonomic dysfunctions that reduce quality of life (QoL). Epidural spinal cord stimulation (eSCS) has shown potential in restoring function in chronic individuals with SCI. However, research on cervical, and autonomic dysfunction-related SCI remains limited. This study will assess the safety and efficacy of eSCS in improving autonomic and volitional functions, as well as truncal stability, bowel, bladder, and sexual function, and overall QoL.
The study is a Phase I/II trial in which participants will serve as their own controls. The Abbott Eterna epidural stimulator system will be implanted, and assessments will occur every three months. The study will be conducted over a period of four years. A total of 36 participants will be enrolled and followed for one year.
Bayesian Optimization will be used to determine the most effective stimulation settings, with 15 settings programmed at the end of each visit.
FDA and UMN IRB approvals have been secured for the study. Interim reports will be made available through peer-reviewed journals, conference presentations, and clinical network reporting.
CE-STAND seeks to advance SCI treatment by expanding eSCS applications in chronic cervical SCI, improving patient outcomes, and reducing healthcare costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal injury patients | Experimental | Device: Epidural Spinal Cord Stimulation SystemExperimental: Individuals with cervical SCI comparing stimulation "on" vs "off" longitudinally. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Twenty two years of age or older
- Able to undergo the informed consent/assent process
- Stable, motor-complete SCI
- Discrete SCI between C4 and C7 (upper extremity weakness)
- ASIA A or B SCI Classification
Key exclusion criteria (17 listed)
- Diseases and conditions that would increase the morbidity and mortality of this surgery such as cardiopulmonary.
- Individuals who require respiratory support, including ongoing or intermittent use of a ventilator and/or diaphragmatic pacer
- Inability to withhold antiplatelet/anticoagulation agents perioperatively
- Individuals who have history of recurrent autonomic dysreflexia in the judgment of the PI
- Significant dysautonomia that would prohibit rehabilitation or any history of cerebrovascular accident or myocardial infarction associated with autonomic dysreflexia. A single tilt table test with syncope, presyncope, or SBP < 50 or > 200
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 Stimulation SystemAbbott Eterna system implantable pulse generator (IPG), charger, and TriCentrus lead | Device | Spinal injury patients |
Primary outcome
Safety of epidural spinal cord stimulator in chronic cervical patients
Time frame: 1 year
Incidence of adverse events (AEs) and serious adverse events (SAEs) including hypotension, other hemodynamic instability, infection, bleeding, significant pain, spasticity, or cerebrospinal fluid leak.
5 secondary outcomes
Changes in blood pressure
Time frame: 1 year
Changes in heart rate
Time frame: 1 year
Cognitive function
Time frame: 1 year
Cerebral blood flow
Time frame: 1 year
Muscle Sympathetic Nerve Activities (MSNA)
Time frame: 1 year
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 27 Mar 2026.
- Derived from this study: PubMed 41688122Mansour N, Keller-Ross M, Low W, Balser DY, Parr A. Effect of Cervical Epidural STimulation After Neurological Damage: protocol for phase I/II open label controlled CE-STAND trial. BMJ Open. 2026 Feb 12;16(2):e107661. doi: 10.1136/bmjopen-2025-107661.
- Individual participant dataSharing planned: Yes. De-identified data will be deposited in the Data Repository for the University of Minnesota (DRUM), an open-access institutional repository. Data stored during the project will be maintained in Box Secure Storage and REDCap before long-term archiving in DRUM.
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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.
Nadine Mansour, MD, MPH, PhD contact
Ann Parr, MD, PhD principal investigator
University of Minnesota
Manda Keller-Ross, PhD, DPT, PT principal investigator
University of Minnesota
Nadine Mansour, MD, MPH, PhD 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 Phase 1/2 study testing Epidural Spinal Cord Stimulation System in people with Spinal Cord Injury, 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 10 inclusion and 17 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 27 Mar 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ann Parr, MD, PhD (612-625-4102, ce-stand@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of epidural spinal cord stimulator in chronic cervical patients (time frame: 1 year). 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 NCT06410001, which also lists 1 linked publication.
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 27 Mar 2026.