Epidural Stimulation After Neurologic Damage: Long-Term Outcomes

NCT05705453 | Recruiting FDA Device

• 1 other identifier: IRB-FY2022-365
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the long-term effect of chronic spinal cord stimulation to restore volitional movement for patients with chronic spinal cord injuries.

Conditions

SCI - Spinal Cord Injury

Keywords

spinal cord stimulation; epidural stimulation

Outcome Measures

Primary Outcomes (1)

• Change in Volitional electromyography (EMG) power

  The measurement of volitional change using EMG during the Brain Motor Control assessment between nonstimulation baseline and stimulation

  10 years

Secondary Outcomes (1)

• Prediction of power preferences

  10 years

Study Arms (1)

Volitional EMG power

EXPERIMENTAL

Assessing the change in volitional EMG power during the Brain Motor Control Assement (BMCA) between nonstimulation baseline and stimulation.

Device: Epidural Spinal Cord Stimulation

Interventions

Epidural Spinal Cord Stimulation DEVICE

Stimulation of the spinal cord from the epidural space.

Volitional EMG power

Eligibility Criteria

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

You may qualify if:

• years of age or older
• Able to undergo the informed consent process
• Stable spinal cord injury
• International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) neurologic level of injury below C5
• No ventilator dependency within the last year
• American Spinal Injury Association (AISA) imparement scale"A" or "B" in the absence of spinal cord stimulation
• Medically stable in the judgment of the Principal investigator
• Greater than 1 year since initial injury and at least 6 months from any required spinal instrumentation and 2 months from spinal cord stimulator surgery
• Has an existing and functional implanted spinal cord stimulator system that is FDA approved and can be corroborated by hospital documentation
• Spinal imaging of the stimulator system

You may not qualify if:

• Current and anticipated need for opioid pain medications or pain that would prevent full participation in the rehabilitation program in the judgment of the principal investigator
• Use of botulinum toxin (Botox) injections in the previous six months
• Clinically significant mental illness in the judgment of the principal investigator
• Other conditions or medications that would make the subject unable to participate in testing/rehabilitation in the judgment of the principal investigator
• Nonfunctional spinal cord stimulator or near end-of-life, determined by the PI
• Current Pregnancy
• Current pain relief from the spinal cord stimulator if the indication for implantation was for management of chronic pain.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

RECRUITING

Related Links

• Clinical Trial Website

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• David Darrow, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

612-873-9113; estand@umn.edu

Study Coordinator

CONTACT

612-873-9113; rnl@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 30, 2023
• Study Start: May 11, 2023
• Primary Completion (Estimated): April 1, 2033
• Study Completion (Estimated): April 1, 2034
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)