Epidural Stimulation After Neurologic Damage: Long-Term Outcomes

SCI - Spinal Cord Injury Clinical Trial

— LTO  

Official title:

Epidural Stimulation After Neurologic Damage: Long-Term Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05705453
• Other study ID #: IRB-FY2022-365
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: April 1, 2034

Study information

• Verified date: April 2024
• Source: University of Minnesota
• Contact: Study Coordinator
• Phone: 612-873-9113
• Email: estand[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 1, 2034
• Est. primary completion date: April 1, 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• SCI - Spinal Cord Injury
• Spinal Cord Injuries

Intervention

Device:
• Epidural Spinal Cord Stimulation
Stimulation of the spinal cord from the epidural space.

Locations

Country	Name	City	State
United States	Hennepin County Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Prediction of power preferences	Prediction of power of preference models built based on evaluations of stimulation settings.	10 years

External Links

•   Clinical Trial Website