NCT07310381Not yet recruitingNot Applicable
Vagus Nerve Stimulation (VNS) Electroencephalogram (EEG) Protocol Supplement
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Stanford University
- Enrollment
- 12
- Primary Endpoint
- Gamma and theta band phase-amplitude coupling
Study Overview
Brief Summary
The study will examine the autonomic, physiologic and neurophysiologic effects of implanted Vagus Nerve Stimulation (VNS) in treatment-resistant depression patients.
Detailed Description
The purpose of this study is to examine the autonomic and physiologic effects of implanted VNS in treatment-resistant depression patients. To examine the neurophysiologic effects of Vagus Nerve Stimulation (VNS) in treatment-resistant depression.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 enrolled in the REVEAL study and implanted with a VNS device for the clinical indication of Major Depressive Disorder (MDD)
- •a. 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.
- •For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.
- •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.
Exclusion Criteria
- •Participant is pregnant
- •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 MRI (ferromagnetic metal in their body)
- •Contraindication to EEG
- •Medication Contraindications
Outcomes
Primary Outcomes
Gamma and theta band phase-amplitude coupling
Time Frame: Baseline, Week 6 and Week 19
Measurement of EEG and ECG to quantify changes in phase-amplitude coupling in the gamma and theta band related to chronic VNS
Secondary Outcomes
- Resting state functional connectivity between the left dorsolateral prefrontal cortex and subgenual anterior cingulate cortex(Baseline, Week 6 and Week 19)
- Heart brain coupling(Week 19)
- Heart rate(Baseline, Week 6 and Week 19)
Investigators
Christopher Wallace Austelle
Clinical Assistant Professor, Department of Psychiatry & Behavioral Sciences, Stanford University School of Medicine
Stanford University
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