Spine and brain stimulation to restore arm and hand movement after cervical spinal cord injury.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot interventional protocol uses temporary epidural stimulation leads placed next to the cervical spinal cord and pairs those with transcranial magnetic brain stimulation over a 29-day series of experiments. Participants undergo mapping of motor responses to spinal cord stimulation, sessions that pair stimulation with attempted voluntary movements, and combined spine–brain stimulation to probe residual motor pathways. Investigators will record motor responses and standardized upper-extremity function scores while adjusting stimulation timing and intensity to identify effective settings. The study focuses on adults with chronic incomplete traumatic cervical injuries and involves inpatient procedures and repeated testing sessions to characterize safety and potential functional effects.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Jason B. Carmel, MD, PhD — Columbia University
• Study coordinator: Evan F. Joiner, MD
• Email: efj2107@cumc.columbia.edu
• Phone: 212-305-2700

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.