Spinal Cord Stimulation for Spinal Cord Injury
(SCAP Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial requires that your prescription medications remain stable for 30 days before screening, so you should not change your current medications during this time.
What data supports the effectiveness of the treatment for spinal cord injury?
Research shows that pairing brain and spinal cord stimulation can significantly enhance muscle responses, with effects being over five times larger than brain stimulation alone. Additionally, long-term paired associative stimulation has been shown to restore voluntary movement in paralyzed muscles in some spinal cord injury patients, suggesting it can strengthen neural connections and improve motor function.12345
Is spinal cord stimulation generally safe for humans?
Spinal cord stimulation (SCS) is considered a safe and reversible treatment for certain pain conditions, with studies indicating it can be safely performed even in complex cases, such as those with epidural scar tissue. However, specific risks associated with the removal of paddle electrodes used in SCS are not well defined in the literature.23467
How does the treatment for spinal cord injury using spinal cord associative plasticity (SCAP) differ from other treatments?
This treatment is unique because it uses a combination of brain and spinal cord stimulation to strengthen weak neural connections, potentially restoring voluntary movement in paralyzed muscles. Unlike other treatments, it focuses on timing-dependent synergies between the motor cortex and spinal cord to enhance muscle responses, offering a novel approach to rehabilitation.13458
What is the purpose of this trial?
Spinal cord associative plasticity (SCAP) is a combined cortical and spinal electrical stimulation technique developed to induce recovery of arm and hand function in spinal cord injury.The proposed study will advance understanding of SCAP, which is critical to its effective translation to human therapy. The purpose of the study is to:1. Determine whether signaling through the spinal cord to the muscles can be strengthened by electrical stimulation.2. Improve our understanding of the spinal cord and how it produces movement.3. Determine whether spinal surgery to relieve pressure on the spinal cord can improve its function.Aim 1 is designed to advance mechanistic understanding of spinal cord associative plasticity (SCAP).Aim 2 will determine whether SCAP increases spinal cord excitability after the period of repetitive pairing. In rats, SCAP augments muscle activation for hours after just 5 minutes of paired stimuli.Whereas Aims 1 and 2 focused on the effects of paired stimulation in the context of uninjured spinal cord, Aim 3 assesses whether paired stimulation can be effective across injured cord segments. Aim 3 will incorporate the experiments from Aim 1 and 2 but in people with SCI, either traumatic or pre-operative patients with myelopathy in non-invasive experiments, or targeting myelopathic segments in intraoperative segments.
Research Team
Jason B Carmel, MD, PhD
Principal Investigator
Columbia University
Eligibility Criteria
This trial is for adults aged 18-80 with spinal cord injuries or cervical myelopathy who may undergo surgery. Able-bodied participants without neurological diseases can join too. Participants must not use certain drugs, have a history of seizures, metal implants in the head (except dental), stimulators, or severe cardiovascular issues.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo non-invasive and intraoperative paired cortical and spinal stimulation to study immediate and lasting effects of SCAP
Follow-up
Participants are monitored for safety and effectiveness after treatment, including muscle response measurements
Extension
Optional continuation of SCAP treatment to assess long-term effects
Treatment Details
Interventions
- Intraoperative pairing of cortical and spinal stimulation
- Intraoperative repeated pairing of cortical and spinal stimulation (SCAP)
- Intraoperative repeated pairing of cortical and spinal stimulation (SCAP) at or below myelopathic region
- Non-invasive pairing of cortical and spinal stimulation
- Non-invasive repeated pairing of cortical and spinal stimulation (SCAP)
Intraoperative pairing of cortical and spinal stimulation is already approved in United States for the following indications:
- Spinal cord injury
- Amyotrophic lateral sclerosis (ALS)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Columbia University
Lead Sponsor
Bronx Veterans Medical Research Foundation, Inc
Collaborator
Weill Medical College of Cornell University
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator