RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Stimulation of the spinal cord and brain represents a new experimental therapy that may have potential to restore movement after spinal cord injury. While some scientists have begun to study the effect of electrical stimulation on patient's ability to walk and move their legs after lower spinal cord injury, the use of stimulation of the upper (cervical) spine to restore arm and hand function after cervical spinal cord injury remains less well explored. The investigators are doing this research study to improve understanding of whether cervical spinal cord stimulation and brain stimulation can be used to improve arm and hand function. To do this, the investigators will combine spine stimulation (in the form of electrical stimulation from electrical stimulation wires temporarily implanted next to the cervical spinal cord) and brain stimulation (in the form of transcranial magnetic stimulation). The investigators will perform a series of experiments over 29 days to study whether these forms of stimulation can be applied and combined to provide improvement in arm and hand function.

Official Title

Pilot Study to Evaluate the Safety and Tolerability of Spinal Cord Stimulation (SCS) and Paired Spine And Brain Stimulation For Movement Recovery After Spinal Cord Injury (SCI)

Quick Facts

Study Start:2025-07-01
Study Completion:2027-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06867809

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * At least 2/5 motor power in at least one upper extremity muscle group
  3. * International Standards for Neurological Classification of Spinal Cord Injury Upper Extremity Motor Score (ISNCSCI-UEMS) ≤ 40/50
  4. * Able to follow multistep commands
  5. * Ability and willingness to provide informed consent
  6. * English speaking
  1. * Cervical or thoracic stenosis that would preclude safe lead placement
  2. * Any ongoing ventilator use (continuous or intermittent)
  3. * Urinary tract infection or pneumonia requiring treatment (within past 3 months)
  4. * Skin ulcers or other lesions
  5. * History of posterior cervical fusion
  6. * Autonomic dysreflexia requiring treatment (within past 3 months)
  7. * Implanted brain stimulators
  8. * Intracranial aneurysm clips
  9. * Ferromagnetic metallic implants in the head (except for within mouth)
  10. * 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)
  11. * Cochlear implants
  12. * Cardiac pacemaker/defibrillator
  13. * Any history of seizures
  14. * Family history of idiopathic epilepsy in a first degree relative
  15. * Bipolar disorder
  16. * Any history of suicide attempt
  17. * Active psychosis
  18. * Intracranial lesion or increased intracranial pressure
  19. * History of stroke or intracranial neurologic conditions with structural damage
  20. * Medications that lower seizure threshold
  21. * Substance use that lowers seizure threshold (heavy alcohol use)
  22. * Moderate to severe heart disease
  23. * Pregnancy or plans to become pregnant within the study period
  24. * Any other medical or psychological condition that precludes involvement in the study as determined by a study physician

Contacts and Locations

Study Contact

Evan F. Joiner, MD
CONTACT
212-305-2700
efj2107@cumc.columbia.edu
Emelly Carrasco
CONTACT
(212) 305-2700
ec3267@cumc.columbia.edu

Principal Investigator

Jason B. Carmel, MD, PhD
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

NewYork-Presbyterian Hospital / Columbia University Irving Medical Center (NYPH/CUIMC)
New York, New York, 10032
United States
NewYork-Presbyterian Allen Hospital / Columbia University Irving Medical Center (NYPH/CUIMC)
New York, New York, 10034
United States

Collaborators and Investigators

Sponsor: Jason Carmel

  • Jason B. Carmel, MD, PhD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-01
Study Completion Date2027-03-31

Study Record Updates

Study Start Date2025-07-01
Study Completion Date2027-03-31

Terms related to this study

Keywords Provided by Researchers

  • Spinal Cord Injury
  • Spinal Cord Stimulation
  • Neurorehabilitation
  • Neurological Recovery

Additional Relevant MeSH Terms

  • Spinal Cord Injury
  • Spinal Cord Injury Cervical