Transcutaneous Vagus Nerve Stimulation for the Treatment of Lupus

Exclusion Criteria

• •1. Acute lupus nephritis defined as class II,III, IV or V nephritis diagnosed within 6 months or prot/creat \> 1.5 gm/gm due to active lupus or in process of receiving induction therapy for nephritis
• •2. Active CNS lupus affecting mental status
• •3. Any other organ threatening or life threatening manifestation of SLE as well as those, who, in the opinion of the investigator, have severe multi-organ or refractory lupus
• •4. Rituximab treatment within 6 months prior to screening and/or without return of B cells to baseline levels
• •5. Treatment with cyclophosphamide within a month prior to screening
• •6. Treatment with any investigational drug within 3 months or 5 half-lives whichever is longer
• •7. Recurrent vaso-vagal syncopal episodes
• •8. Unilateral or bilateral vagotomy
• •9. Presence of any evidence of vagus nerve pathology or injury
• •10. Heart failure (NYHA class III or IV)
• •11. Known atherosclerotic disease, including severe carotid artery disease, uncontrolled hypertension, uncontrolled diabetes, and history of myocardial infarction (MI), cardiomyopathy or stroke within the past year. Clinically stable patients with coronary artery disease, but no recent MI (within the past year) and no current symptoms of angina are not however excluded.
• •12. Valvular and other structural heart disease that is evident by transthoracic echocardiogram and is associated with heart failure (NYHA class III or IV)
• •13. Prolonged QT interval or abnormal baseline ECG - sick sinus syndrome, Mobitz type 2 second or third degree heart block, atrial fibrillation, atrial flutter, recent history of ventricular tachycardia or ventricular fibrillation or clinically significant premature ventricular contraction
• •14. Individuals currently implanted with an electrical and/or neurostimulator device, such as cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant
• •15. Known respiratory disease that has decreased any pulmonary function test more than 25% below expected values or has resulted in hospitalization within the past year
• •16. All diagnosed syndromes affecting the central nervous system (CNS) or autonomic nervous system
• •17. Major psychiatric disorders including evidence of major depressive disorder (DSM-5 diagnostic criteria) that is not currently controlled by medications
• •18. Hemoglobin below 9.0 gm/dL (by the most recent CBC)
• •19. Pregnancy or breast feeding
• •20. Inability or unwillingness to understand and/or sign informed consent
• •21. Any other medical condition, whether or not related to lupus, which, in the opinion of the investigator, would render the patient inappropriate or too unstable to complete the study protocol