Vagus Nerve Stimulation (VNS) Electroencephalogram (EEG) Protocol Supplement
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vagus Nerve Stimulation.
- Who it may be relevant to
- Registry conditions: Treatment Resistant Depression. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device Vagus Nerve Stimulation
Participants receiving vagus nerve stimulation through an implanted Vagus Nerve Stimulation Device.
Primary outcome measures
- Gamma and theta band phase-amplitude coupling [Time frame: Baseline, Week 6 and Week 19]
Secondary outcome measures (3)
- Resting state functional connectivity between the left dorsolateral prefrontal cortex and subgenual anterior cingulate cortex [Time frame: Baseline, Week 6 and Week 19]
- Heart brain coupling [Time frame: Week 19]
- Heart rate [Time frame: Baseline, Week 6 and Week 19]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07310381 · 80038