Targeted Plasticity Therapy for Upper Limb Rehabilitation in Spinal Cord Injuries

This is an interventional device feasibility trial for Spinal Cord Injuries focused on measuring Vagus Nerve Stimulation (VNS), Rehabilitation, Targeted Plasticity Therapy Read More

Inclusion Criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Adult, aged 18-64
• In good general health as evidenced by medical history and diagnosed with first time cervical spinal cord injury resulting in an ASIA grade B, C, or D, and level 1 or better motor function as described by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI).
• SCI caused by trauma that occurred ≥ 12 months prior to enrollment
• Meets all clinical criteria for the surgical VNS implantation as determined by the PI, surgeon, and anesthesiologist
• Must demonstrate some residual upper limb and hand movement in either arm
• Appropriate candidate for VNS implantation
• Willing and able to comply with the study protocol

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
• Participants with prior right-sided anterior cervical surgery will require laryngoscopy prior to randomization. Those with evidence of recurrent laryngeal nerve injury will be excluded.
• Participants with prior left sided anterior cervical surgery will be eligible, regardless of prior recurrent laryngeal nerve injury. However, if at surgery there is too much scar tissue for safe implantation the surgery will be abandoned to ensure participant safety
• 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
• Participants with 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.).
• Participants with active neoplastic disease.
• Participants with significant local circulatory problems, (e.g. thrombophlebitis and lymphedema, and clinically-significant hypotension or bradycardia).
• 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.
• Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of device's safety and performance.
• Aphasia and other cognitive deficits may be present but participants will be excluded if are unable to understand the potential risks and benefits of the study or 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