CE-STAND: Cervical Epidural STimulation After Neurologic Damage

March 26, 2026 updated by: University of Minnesota
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Spinal injury patients
Experimental: Individuals with cervical SCI comparing stimulation "on" vs "off" longitudinally.
Device: Epidural Spinal Cord Stimulation System
Abbott Eterna system implantable pulse generator (IPG), charger, and TriCentrus lead

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in blood pressure
Time Frame: 1 year
Measured on tilt table testing. Both systolic and diastolic pressure will be assessed
1 year
Changes in heart rate
Time Frame: 1 year
Measured on tilt table testing
1 year
Cognitive function
Time Frame: 1 year
Measured using N-back testing
1 year
Cerebral blood flow
Time Frame: 1 year
Measured using transcranial doppler
1 year
Muscle Sympathetic Nerve Activities (MSNA)
Time Frame: 1 year
Microneurolography
1 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Volitional function on electromyography (EMG)
Time Frame: 1 year
Using the modified brain motor control assessment (mBMCA) and electromyography (EMG).
1 year
Hand function
Time Frame: 1 year
The Graded Redefined Assessments of Strength, Sensibility, and Prehension (GRASSP) functional score
1 year
Truncal stability
Time Frame: 1 year
Using the modified Functional reach test (mFRT)
1 year
Stimulation settings optimization
Time Frame: 1 year
Using Bayesian process
1 year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Minnesota

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ann Parr, MD, PhD, University of Minnesota
  • Principal Investigator: Manda Keller-Ross, PhD, DPT, PT, University of Minnesota
  • Principal Investigator: Nadine Mansour, MD, MPH, PhD, 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NEUROSURG-2023-31800

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data will be shared after publication of the primary results and will remain available for at least 10 years, in accordance with the University of Minnesota's DRUM repository policies.

IPD Sharing Access Criteria

Data will be openly accessible through DRUM without restrictions.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

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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