Targeted Plasticity Therapy for Upper Limb Rehabilitation in Spinal Cord Injuries

Exclusion Criteria

• •An individual who meets any of the following criteria will be excluded from participation in this study:
• •Spinal cord injuries by sharp objects, firearms, and non-traumatic or congenital causes, even if at different levels of the spinal cord
• •Any evidence of recurrent laryngeal nerve injury (Evident during required laryngoscopy for all participants with Prior right-sided anterior cervical surgery- done prior to randomization)
• •Excessive scar tissue marking implantation unsafe (evident at surgery)
• •Concomitant clinically significant brain injuries
• •Prior injury to vagus nerve
• •Prior or current treatment with vagus nerve stimulation
• •Participant receiving any therapy (medication or otherwise) that would interfere with VNS
• •Pregnancy or lactation
• •Clinical complications that hinder or contraindicate the surgical procedure
• •Psychiatric disorders, psychosocial, and/or cognitive impairment that would interfere with study participation, as assessed by medical evaluation
• •Abusive use of alcohol and/or illegal substances use
• •Participation in other interventional clinical trial
• •Participants with known immunodeficiency including participants who are receiving or have received chronic corticosteroids, immunosuppressants, immunostimulating agents or radiation therapy within 6 months
• •Significant comorbidities or conditions associated with high risk for surgical or anesthetic survival (e.g. renal failure, peripheral vascular disease, unstable cardiac disease, poorly controlled diabetes, immunosuppression, etc.).
• •Active neoplastic disease.
• •Participants with significant local circulatory problems, (e.g. thrombophlebitis and lymphedema).
• •Participants with any medical condition or other circumstances that might interfere with their ability to return for follow-up visits in the judgment of the Investigator, including systemic illness, neuromuscular, neurosensory, or musculoskeletal deficiency that would render the participant unable to perform appropriate postoperative rehabilitation.
• •Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of device's safety and performance.
• •Aphasia and other cognitive deficits that make understanding the potential risks and benefits of the study impossible for participant. Inability to personally provide informed consent.
• •A recent history of syncope
• •A recent history of dysphagia
• •Currently require, or are likely to require diathermy
• •Significant respiratory issues that would interfere with participation
• •Non-English speaking
• •Patients who are acutely suicidal and/or have been admitted for a suicide attempt
• •Incarceration or legal detention