NCT06867809 · Jason Carmel
Spine and Brain Stimulation for Movement Recovery After Cervical Spinal Cord Injury
What this study is about
Stimulation of the spinal cord and brain represents a new experimental therapy that may have potential to restore movement after spinal cord injury.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- New York, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 30, 2025 · Source of record for eligibility and locations