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

This study is exploring a new approach to help people with cervical spinal cord injury (SCI) regain arm and hand movement. Researchers are testing a device that provides epidural spinal cord stimulation and paired spine and brain stimulation. This involves temporarily placing small wires near your spinal cord and stimulating your brain. They want to understand if this stimulation can improve arm and hand function. You might be able to join if you are 18 or older, have an incomplete traumatic SCI (C4 to T1) that happened over a year ago, and have some remaining movement in your upper extremities. The study will look for serious side effects and if participants choose to stop stimulation within 30 weeks. The current recruitment status is unclear.

Study design: This is an interventional pilot study with a planned enrollment of 20 participants. It is not specified if it is randomized or blinded.
What's involved: Participants will undergo temporary placement of electronic stimulation wires near the cervical spinal cord. This will be followed by a series of experiments over 29 days.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed from enrollment until 30 weeks after the start of the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting

NAAges 18+InterventionalTreatment

Jason Carmel

~20 participants

Updated 2025-10-30 on ClinicalTrials.gov

What's tested:Epidural spinal cord stimulation and paired spine and brain stimulation

At a glance

Recruiting sites

2 of 2 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Serious adverse events related to the study device

Measured over From enrollment to the end of follow up at 30 weeks

+1 more outcome measured

Conditions

Spinal Cord Injury

Spinal Cord Injury Cervical

NCT06867809

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

NewYork-Presbyterian Allen Hospital / Columbia University Irving Medical Center (NYPH/CUIMC)
New York, New Yorkstudy coordinator listed
Recruiting
NewYork-Presbyterian Hospital / Columbia University Irving Medical Center (NYPH/CUIMC)
New York, New Yorkstudy coordinator listed
Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

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

Who to contact

Evan F. Joiner, MD

[email protected]

212-305-2700 · ext. 3

Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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

What this trial measures

Serious adverse events related to the study deviceFrom enrollment to the end of follow up at 30 weeks
To assess safety of spinal cord stimulation and paired spine and brain stimulation for movement recovery after spinal cord injury, the investigators will record the number of serious adverse events related to the study device.
Cessation of spinal cord stimulation or brain stimulation due to participant requestFrom enrollment to the end of follow up at 30 weeks
To assess tolerability of spinal cord and brain stimulation for movement recovery after spinal cord injury, the investigators will record the number of instances a participant requests permanent cessation of stimulation.

Trialytics