Epidural Stimulation After Neurologic Damage: Long-Term Outcomes

NCT ID: NCT05705453

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2034-04-01

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.

Detailed Description

Participants will be enrolled in this study for the duration of 10 years. They will need to come to Minneapolis twice a year for the Brain Motor Control Assessment and will be given different settings within their Spinal Cord Stimulator (SCS) programing.

Conditions

SCI - Spinal Cord Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Volitional EMG power

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

Group Type: EXPERIMENTAL

Epidural Spinal Cord Stimulation

Intervention Type: DEVICE

Stimulation of the spinal cord from the epidural space.

Interventions

Epidural Spinal Cord Stimulation

Stimulation of the spinal cord from the epidural space.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 22 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Darrow, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Study Coordinator

Role: CONTACT

estand@umn.edu

612-873-9113

Study Coordinator

Role: CONTACT

rnl@umn.edu

612-873-9113

Facility Contacts

Tara Nash, FNP

Role: primary

estand@umn.edu

612-873-9113

Study Coordinator

Role: backup

rnl@umn.edu

Related Links

http://estand.org

Clinical Trial Website

Other Identifiers

IRB-FY2022-365

Identifier Type: -

Identifier Source: org_study_id