CE-STAND: Cervical Epidural STimulation After Neurologic Damage

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: Recruiting
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Device: Epidural Spinal Cord Stimulation System

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: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Ann Parr, MD, PhD; Phone Number: 612-625-4102; Email: ce-stand@umn.edu
• Study Contact Backup: Name: Nadine Mansour, MD, MPH, PhD; Email: ce-stand@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota
      • Contact: Ann Parr, MD, PhD; Phone Number: 612-625-4102; Email: amparr@umn.edu

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in blood pressure	Measured on tilt table testing. Both systolic and diastolic pressure will be assessed	1 year
Changes in heart rate	Measured on tilt table testing	1 year
Cognitive function	Measured using N-back testing	1 year
Cerebral blood flow	Measured using transcranial doppler	1 year
Muscle Sympathetic Nerve Activities (MSNA)	Microneurolography	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volitional function on electromyography (EMG)	Using the modified brain motor control assessment (mBMCA) and electromyography (EMG).	1 year
Hand function	The Graded Redefined Assessments of Strength, Sensibility, and Prehension (GRASSP) functional score	1 year
Truncal stability	Using the modified Functional reach test (mFRT)	1 year
Stimulation settings optimization	Using Bayesian process	1 year

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: 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

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2026
• Primary Completion (Estimated): May 31, 2030
• Study Completion (Estimated): July 30, 2030

Study Registration Dates

• First Submitted: April 19, 2024
• First Submitted That Met QC Criteria: May 7, 2024
• First Posted (Actual): May 10, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Cervical; Spinal cord injury; Autonomic dysfunction; Epidural spinal cord stimulation
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Autonomic Nervous System Diseases; Spinal Cord Injuries; Primary Dysautonomias
• Other Study ID 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