Vagus Nerve Stimulation (VNS) in Spinal Cord Injury (SCI) Adaptive Follow-On Study

Exclusion Criteria

• •1. Concurrent participation in another active interventional trial or participation in an active interventional trial within 7 days prior to enrollment
• •2. Any medical condition or other circumstances that might interfere with their ability to return for follow-up visits in the judgment of the Investigator
• •3. Any condition which would preclude adequate evaluation of device's safety and performance in the judgment of the Investigator
• •5. Concomitant clinically significant brain injuries
• •6. Receiving any other therapy that would interfere with VNS
• •7. Females of childbearing potential who are either pregnant, lactating, heterosexually active, or planning to become pregnant or heterosexually active during study participation; and who are not using, or will not agree to use medically acceptable birth control methods
• •8. Psychiatric disorders, psychosocial, and/or cognitive impairment that would interfere with study participation, as assessed by medical evaluation
• •9. Participants with a current or past: (i) medical (psychiatric, non-psychiatric) condition, disease, disorder, injury, or disability; or (ii) non-medical situation or circumstance that, in the opinion of the principal investigator, study participation:
• •1. May pose a significant or undue risk to the person;
• •2. Make it unlikely the person will complete all the study requirements per protocol; or
• •3. May adversely impact the integrity of the data or the validity of the study results
• •10. Participants with active neoplastic disease.
• •11. Participants with significant local circulatory problems, (e.g. thrombophlebitis and lymphedema, and clinically-significant hypotension or bradycardia).
• •12. 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.
• •13. Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of device's safety and performance.
• •14. 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.
• •15. A recent history of syncope
• •16. A recent history of dysphagia
• •17. Currently require, or are likely to require diathermy
• •18. Significant respiratory issues that would interfere with participation
• •19. Non-English speaking
• •20. Patients who are acutely suicidal and/or have been admitted for a suicide attempt
• •21. As determined by the principal investigator, is under current incarceration or legal detention
• •Upper Limb (UL):
• •1)None
• •Lower Limb (LL):
• •1)None
• •Bladder Control (BC):
• •1)Indwelling catheter use 2)Participants with a history of severe or recurrent autonomic dysreflexia 3)Technical limitations that would preclude bladder ultrasonography assessments 4)Medical history that would preclude adequate evaluation of urologic outcomes
• •Sensory (SY):
• •1. Pain that would impede study participation