Exploring spinal cord stimulation and training for spinal cord injuries
Neural Plasticity by Spinal Cord Stimulation and Training in People With Spinal Cord Injury
This study is testing if spinal cord stimulation can help improve movement and recovery in people with spinal cord injuries by looking at how it affects their nervous system.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 16 Years to 65 Years |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT05472584 on ClinicalTrials.gov |
What this trial studies
This project aims to investigate how spinal cord stimulation (SCS) affects neural circuits involved in motor function improvements for individuals with spinal cord injuries (SCI). The study will assess both short-term excitability and long-term plasticity of corticospinal, reticulospinal, and spinal neural circuits through various interventions, including electrophysiology assessments and activity-based training. By understanding the neural mechanisms enhanced by SCS, the research seeks to develop targeted therapies that promote recovery in individuals with chronic SCI.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 16-65 with traumatic spinal cord injuries at the C4-T9 level who have difficulty performing leg movements and are at least one year post-injury.
Not a fit: Patients outside the age range of 16-65, those with major comorbidities, or individuals with acute or chronic pain conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved rehabilitation strategies for individuals with spinal cord injuries, enhancing their motor function and quality of life.
How similar studies have performed: Other studies have shown promise in using spinal cord stimulation for rehabilitation, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Healthy Volunteers * Age between 16 and 65 years old * Healthy people with no major comorbidities of any organ system Exclusion Criteria: Healthy Volunteers * Subjects younger than 16 or older than 65 years old * Subjects not providing consent or not able to consent * Subjects with any acute or chronic pain condition * Subjects with any acute or chronic disease of a major organ system * Use of analgesics within 24 hours prior to study period * Use of caffeine with 3 hours of study appointment Inclusion criteria: Participants with spinal cord injury (SCI) * Age between 16-65 years old * Traumatic SCI C4-T9 level, incomplete (ASIA C or D) * at least 1 year post injury * Stable medical condition * difficulty independently performing leg movements in routine activities * able to follow simple commands * able to speak and respond to questions Exclusion criteria: Participants with spinal cord injury (SCI) * Subjects younger than 16 or older than 65 years old * Not willing or able to provide consent * Any acute or chronic pain condition * Any acute or chronic disease of a major organ system * Use of analgesics within 24 hours prior to study appointment * Use of caffeine with 3 hours of study appointment * Presence of tremors, spasms and other significant involuntary movements * Etiology of SCI other than trauma * Concomitant neurologic disease traumatic brain injury (TBI) that will significantly impact the ability to follow through on study directions, multiple sclerosis (MS), stroke or peripheral neuropathy) * History of significant medical illness (cardiovascular disease, uncontrolled diabetes, uncontrolled hypertension, osteoporosis, cancer, chronic obstructive pulmonary disease, severe asthma requiring hospitalization for treatment, renal insufficiency requiring dialysis, autonomic dysreflexia, etc). * Severe joint contractures disabling or restricting lower limb movements. * Unhealed fracture, contracture, pressure sore, urinary tract infection or other uncontrolled infections, other illnesses that might interfere with lower extremity exercises or testing activities * Depression, anxiety, or cognitive impairment * Deficit of visuospatial orientation * Sitting tolerance less than 1 hour * Severe hearing or visual deficiency * Miss more than 3 appointments without notification * Unable to comply with any of the procedures in the protocol * Botulinum toxin injection in lower extremity muscles in the prior six months * Any passive implants (osteosynthesis material, metallic plates or screws) below T9. * Any implanted stimulator in the body (pacemaker, vagus nerve stimulator, etc.) * History of alcoholism or another drug abuse * Pregnancy (or possible pregnancy) * Having an Intrathecal Baclofen Therapy Pump (ITB pump) * History of epilepsy
Where this trial is running
St Louis, Missouri
- Washington University — St Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Ismael Seanez, PhD — Washington University School of Medicine
- Study coordinator: Ismael Seanez, PHD
- Email: ismaelseanez@wustl.edu
- Phone: 314-935-7665
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.