Spine and Brain Stimulation for Movement Recovery 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)
Jason Carmel
20 participants
Jan 15, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria24
- 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
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Interventions
The spinal cord and brain stimulator allows for stimulation of the spinal cord and brain. Spinal cord stimulation (SCS) is provided by temporarily implanted SCS catheter electrode leads (Medtronic) that are connected to an external stimulator (Digitimer); brain stimulation is provided by transcranial magnetic stimulation (TMS).
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06867809