Vagus Nerve Stimulation (VNS) Electroencephalogram (EEG) Protocol Supplement

Korábbi kezelés

• Medication Contraindications

Egyéb

• Participant does not speak or read English
• Any other clinical reasons deemed by the investigator of the study for which the participant would not be an appropriate candidate for the study.
• Contraindication to EEG

• Participants must be at least 18 years old.
• Participants must be able to read, understand and have the capacity to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization.
• Proficiency in English sufficient to complete questionnaire and follow instructions during fMRI assessments and iTBS interventions.
• Willingness to comply with all study procedures and the ability to communicate with study personnel about adverse events and other clinically important information
• Participant must be currently implanted with a VNS device for the clinical indication of Major Depressive Disorder (MDD)
  • Clinical Indication of MDD as defined: Participant has a diagnosis of chronic (≥ 2 years) or ≥ 4 recurrent depressive episodes as defined by DSM-5 criteria documented using the MINI criteria and psychiatric medical record review.
• Access to ongoing psychiatric care before and after completion of the study.
• In good general health, as evidenced by medical history
• Agreement to adhere to Lifestyle Considerations throughout study duration.