About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Epidural spinal cord stimulation and paired spine and brain stimulation
Treatment groups
Sponsors and collaborators
Jason Carmel
Lead sponsor
Columbia University
Sponsor institution
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator