Spine and brain stimulation to restore arm and hand movement after cervical spinal cord injury.
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)
This will try temporary cervical spinal cord electrical stimulation together with noninvasive brain stimulation to improve arm and hand movement in adults with chronic incomplete cervical spinal cord injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT06867809 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18 years) with chronic (>1 year) incomplete traumatic cervical spinal cord injury (ASIA B–D, levels C4–T1) who have at least 2/5 motor power in one upper-extremity muscle group, ISNCSCI-UEMS ≤40/50, can follow multistep commands, and can provide informed consent are the intended candidates.
Not a fit: People with complete spinal cord injury, recent injuries (<1 year), ongoing ventilator dependence, active infections or skin lesions, prior posterior cervical fusion, autonomic dysreflexia requiring recent treatment, implanted brain stimulators, or incompatible metallic head implants are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the approach could improve arm and hand strength and functional use, increasing independence for people with cervical spinal cord injury.
How similar studies have performed: Epidural spinal cord stimulation has restored walking in some prior studies of lower (thoracic) injuries, but applying cervical spinal cord stimulation combined with brain stimulation for upper-limb recovery is relatively novel and less proven.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York and 1 other locations
- 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
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.