NCT05705453 · University of Minnesota
Epidural Stimulation After Neurologic Damage: Long-Term Outcomes
(LTO)
What this study is about
This study will evaluate the long-term effect of chronic spinal cord stimulation to restore volitional movement for patients with chronic spinal cord injuries.
View original scientific description
This study will evaluate the long-term effect of chronic spinal cord stimulation to restore volitional movement for patients with chronic spinal cord injuries.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Minneapolis, Minnesota
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 8, 2026 · Source of record for eligibility and locations