Harnessing Neuroplasticity of Postural Sensorimotor Networks Using Non-Invasive Spinal Neuromodulation to Maximize Functional Recovery After Spinal Cord Injury

Inclusion criteria

• All participants must be able to provide a provision of a signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Male or female, aged 22-75 years old.
• Documentation from the participant's primary treating physician confirming a stable medical condition.
• Inability to maintain standing independently without external support due to SCI AIS A-C.
• Ability to tolerate at least 15 minutes in an upright (supported) position.
• Able to self-transfer from the wheelchair and demonstrate active range of motion of bilateral upper extremities in gravity dependent plane.
• Able to passively range bilateral lower extremities within normal mobility parameters including:
• greater than 90 degrees of hip flexion and 165 degrees of hip extension;
• greater than 90 degrees of knee flexion and reach neutral knee extension of 180 degrees;
• neutral ankle position reaching a minimum of 90 degrees of dorsiflexion.
• Participants should be on a stable intrathecal baclofen or oral anti-spasticity regimen/dose for the period of the study unless advised otherwise by their physician.
• 1 to 30 years post spinal cord injury.
• Non-progressive spinal cord injury.
• Neurological level of injury below C4 and above T12 (excluding conus injury and/or indications of lower motor neuron injury).
• Eligible for fMRI per safety questionnaire.
• Women of childbearing potential must agree to the use of an effective means of avoiding pregnancy for the duration of the study.
• Able to commit to the full study.

Exclusion criteria

• Ability to maintain standing independently without external support.
• Currently involved in another rehabilitation training of the lower extremities.
• Active pressure sores, unhealed bone fractures, peripheral neuropathies, or painful musculoskeletal dysfunction (including but not limited to contractures in the upper and lower extremities).
• Any ongoing medical condition which would preclude participant from regular physical activity (including but not limited to: cardiopulmonary disease, uncontrollable autonomic dysreflexia or orthostatic hypotension, active urinary tract infections, pregnant or nursing).
• Intrathecal baclofen pump therapy for spasticity not compatible with 3T MRI.
• Must not have received Botox injections to primary lower extremity and trunk musculature within the past 3 months, resulting in absence of muscle tone and precluding response to electrical stimulation therapy.
• Current or history of neuromuscular conditions (including but not limited to: unhealed ligament of muscular tears in the upper or lower extremities, pain in weight bearing positions for upper and lower extremities).
• Clinically significant depression, psychiatric disorders, or ongoing drug abuse, including heavy alcohol use.
• Any reason the PI or treating physician may deem as harmful to the participant to enroll or continue in the study.
• Body Mass Index (BMI) over 30.
• Use a ventilator or diaphragmatic pacer.
• Participants with the following conditions will be excluded from TMS, but may take part in the overall study:
• Personal or first-degree family history of seizures or epilepsy.
• Metal in the head, except mouth implants.
• History of suicide attempts.
• History of intracranial lesions, increased intracranial pressure, or stroke.
• Current use of tricyclic anti-depressants, selective serotonin reuptake inhibitors (SSRIs), serotonin nor-epinephrine reuptake inhibitors (SNRIs), buproprion (Wellbutrin), or tramadol.