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Search / Trial NCT06867809

Spine and Brain Stimulation for Movement Recovery After Cervical Spinal Cord Injury

Launched by JASON CARMEL · Mar 5, 2025

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Spinal Cord Injury Spinal Cord Stimulation Neurorehabilitation Neurological Recovery

ClinConnect Summary

This clinical trial is investigating a new way to help people recover movement in their arms and hands after a cervical spinal cord injury. Researchers are exploring whether combining electrical stimulation of the spinal cord and brain can improve arm and hand function. They will use a special type of electrical stimulation placed near the spinal cord and a method called transcranial magnetic stimulation to see if these treatments can work together to help individuals regain movement. The study will take place over 29 days, and while it’s not yet recruiting participants, the goal is to learn more about this experimental therapy.

To be eligible for this study, participants need to be at least 18 years old and have had an incomplete spinal cord injury for more than a year. They should have some movement in at least one arm and be able to follow simple instructions. However, certain health conditions or devices, like implanted stimulators or severe heart disease, may prevent someone from participating. Those who join the study can expect to take part in various experiments designed to assess how well the stimulation techniques work together. This research could potentially lead to new treatment options for improving movement after spinal cord injuries.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients aged ≥18 years with incomplete traumatic SCI (American Spinal Injury Association (ASIA) B-D, levels between C4 to T1) incurred \> 1 year before the start of the study
  • At least 2/5 motor power in at least one upper extremity muscle group
  • International Standards for Neurological Classification of Spinal Cord Injury Upper Extremity Motor Score (ISNCSCI-UEMS) ≤ 40/50
  • Able to follow multistep commands
  • Ability and willingness to provide informed consent
  • English speaking
  • Exclusion Criteria:
  • Cervical or thoracic stenosis that would preclude safe lead placement
  • Any ongoing ventilator use (continuous or intermittent)
  • Urinary tract infection or pneumonia requiring treatment (within past 3 months)
  • Skin ulcers or other lesions
  • History of posterior cervical fusion
  • Autonomic dysreflexia requiring treatment (within past 3 months)
  • Implanted brain stimulators
  • Intracranial aneurysm clips
  • Ferromagnetic metallic implants in the head (except for within mouth)
  • Any active implanted device including intrathecal medication pumps or existing spinal cord stimulators (does not include non-active spinal instrumentation such as rods, screws, or interbody devices)
  • Cochlear implants
  • Cardiac pacemaker/defibrillator
  • Any history of seizures
  • Family history of idiopathic epilepsy in a first degree relative
  • Bipolar disorder
  • Any history of suicide attempt
  • Active psychosis
  • Intracranial lesion or increased intracranial pressure
  • History of stroke or intracranial neurologic conditions with structural damage
  • Medications that lower seizure threshold
  • Substance use that lowers seizure threshold (heavy alcohol use)
  • Moderate to severe heart disease
  • Pregnancy or plans to become pregnant within the study period
  • Any other medical or psychological condition that precludes involvement in the study as determined by a study physician

About Jason Carmel

Jason Carmel is a dedicated clinical trial sponsor focused on advancing medical research and innovation. With a commitment to improving patient outcomes, the organization specializes in designing and conducting rigorous clinical studies across various therapeutic areas. Leveraging a collaborative approach, Jason Carmel partners with leading healthcare institutions and researchers to ensure the highest standards of scientific integrity and ethical practices. The sponsor is driven by a passion for transforming healthcare through evidence-based solutions, ultimately aiming to bring new treatments and therapies to market that enhance the quality of life for patients worldwide.

Locations

New York, New York, United States

New York, New York, United States

Patients applied

MR

1 patients applied

Trial Officials

Jason B. Carmel, MD, PhD

Principal Investigator

Columbia University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported