CE-STAND: Cervical Epidural STimulation After Neurologic Damage

NCT06410001 | Recruiting Phase 1 DMC FDA Device

• 1 other identifier: NEUROSURG-2023-31800
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injury

Keywords

Cervical; Spinal cord injury; Epidural spinal cord stimulation; Autonomic dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Changes in blood pressure

  1 year

• Changes in heart rate

  1 year

• Cognitive function

  1 year

• Cerebral blood flow

  1 year

• Muscle Sympathetic Nerve Activities (MSNA)

  1 year

Other Outcomes (4)

• Volitional function on electromyography (EMG)

  1 year

• Hand function

  1 year

• Truncal stability

  1 year

Study Arms (1)

Spinal injury patients

EXPERIMENTAL

Experimental: Individuals with cervical SCI comparing stimulation "on" vs "off" longitudinally.

Device: Epidural Spinal Cord Stimulation System

Interventions

Epidural Spinal Cord Stimulation System DEVICE

Abbott Eterna system implantable pulse generator (IPG), charger, and TriCentrus lead

Spinal injury patients

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 41688122 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Primary Dysautonomias

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Autonomic Nervous System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann Parr, MD, PhD

CONTACT

612-625-4102; ce-stand@umn.edu

Nadine Mansour, MD, MPH, PhD

CONTACT

ce-stand@umn.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: May 10, 2024
• Study Start: March 15, 2026
• Primary Completion (Estimated): May 31, 2030
• Study Completion (Estimated): July 30, 2030
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• 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.
• Access Criteria: Data will be openly accessible through DRUM without restrictions.

Locations

US (1)