Thinking of joining a study?

Register your interest

NCT05705453 | Recruiting | SCI - Spinal Cord Injury


Epidural Stimulation After Neurologic Damage: Long-Term Outcomes
Sponsor:

University of Minnesota

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.

Condition or disease

SCI - Spinal Cord Injury

Intervention/treatment

Epidural Spinal Cord Stimulation

Phase

Not Applicable

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.

Study Type : Interventional
Estimated Enrollment : 50 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Epidural Stimulation After Neurologic Damage: Long-Term Outcomes
Actual Study Start Date : March 1, 2023
Estimated Primary Completion Date : April 1, 2033
Estimated Study Completion Date : April 1, 2034
Arm Intervention/treatment

Experimental: Volitional EMG power

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

Device: Epidural Spinal Cord Stimulation

Ages Eligible for Study: 22 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.

Epidural Stimulation After Neurologic Damage: Long-Term Outcomes

Location Details


Please Choose a site



Epidural Stimulation After Neurologic Damage: Long-Term Outcomes

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

United States, Minnesota

Hennepin County Medical Center

Minneapolis, Minnesota, United States, 55415

Loading...