NCT06867809 Spine and Brain Stimulation for Movement Recovery After Cervical Spinal Cord Injury
| NCT ID | NCT06867809 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jason Carmel |
| Condition | Spinal Cord Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-01-15 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2026-01-15 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Jason B. Carmel, MD, PhD
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT06867809 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spinal Cord Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06867809 currently recruiting?
Yes, NCT06867809 is actively recruiting participants. Contact the research team at efj2107@cumc.columbia.edu for enrollment information.
Where is the NCT06867809 trial being conducted?
This trial is being conducted at New York, United States, New York, United States.
Who is sponsoring the NCT06867809 clinical trial?
NCT06867809 is sponsored by Jason Carmel. The principal investigator is Jason B. Carmel, MD, PhD at Columbia University. The trial plans to enroll 20 participants.