Vagus nerve stimulation with exercise for long-term spinal cord injury recovery

Other criteria

• General Inclusion Criteria:
• Completed phase 2 of the SCI EFS study (NCT04288245)
• Willing to comply with procedures for the entire duration of the study (study protocol compliance)
• Provision of signed and dated informed consent form
• Access to reliable communication and internet connections (for those intending to complete sessions at home)
• Has not had their VNS device explanted; General Exclusion Criteria:
• Concurrent participation in another active interventional trial or participation in an active interventional trial within 7 days prior to enrollment
• 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 would preclude adequate evaluation of device's safety and performance in the judgment of the Investigator
• Individuals who have a change in medical condition or health status such that they would meet the exclusion criteria of the EFS
• Concomitant clinically significant brain injuries
• Receiving any other therapy that would interfere with VNS
• 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
• Psychiatric disorders, psychosocial, and/or cognitive impairment that would interfere with study participation, as assessed by medical evaluation
• 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:; May pose a significant or undue risk to the person; Make it unlikely the person will complete all the study requirements per protocol; or; May adversely impact the integrity of the data or the validity of the study results
• 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
• As determined by the principal investigator, is under current incarceration or legal detention; Track Specific Inclusion Criteria:; Upper Limb (UL):; 1)None; Lower Limb (LL):; 1)Ambulatory with gait impairment; Bladder Control (BC):; 1)Issues with urinary function arising from SCI, with partial voluntary initiation of voiding 2)Intermittent catheterization for bladder management; Sensory (SY):; 1)Impairment in sensory function, based on the baseline assessments below:
• US-NSA score <92 points
• Two-point discrimination fingertip score >5mm
• Two-point discrimination palm score >15mm
• Tactile Discrimination Test score <16points
• Semmes-Weinstein Monofilaments score >3.61g; Track Specific Exclusion Criteria:; 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):; Pain that would impede study participation