Treatment Resistant DepressionNCT07310381
Vagus Nerve Stimulation (VNS) Electroencephalogram (EEG) Protocol Supplement
A study testing Vagus Nerve Stimulation in people with Treatment Resistant Depression, run by Stanford University.
Trial summary
The study will examine the autonomic, physiologic and neurophysiologic effects of implanted Vagus Nerve Stimulation (VNS) in treatment-resistant depression patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment Resistant Depression
- What is being tested?
- Vagus Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- 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.
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- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Katina Marchione contact
About this study
The study will examine the autonomic, physiologic and neurophysiologic effects of implanted Vagus Nerve Stimulation (VNS) in treatment-resistant depression patients.
Read the 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.
- Conditions
- Treatment Resistant Depression
- Being tested
- Vagus Nerve Stimulation
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagus Nerve StimulationDevice
Participants receiving vagus nerve stimulation through an implanted Vagus Nerve Stimulation Device.
| Study group | Role | What they receive |
|---|---|---|
| Participants implanted with VNS | Other | Participants receiving vagus nerve stimulation through an implanted Vagus Nerve Stimulation Device. Receives: Device: Vagus Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gamma and theta band phase-amplitude coupling
Measurement of EEG and ECG to quantify changes in phase-amplitude coupling in the gamma and theta band related to chronic VNS
Measured: Baseline, Week 6 and Week 19
Secondary outcomes (3)
Resting state functional connectivity between the left dorsolateral prefrontal cortex and subgenual anterior cingulate cortex
Measurement of changes in resting state functional connectivity between the left dorsolateral prefrontal cortex and subgenual anterior cingulate cortex with chronic VNS using fMRI.
Measured: Baseline, Week 6 and Week 19
Heart brain coupling
Measurement of heart brain coupling (heart rate entrainment in response to trains of intermittent theta burst stimulation) with VNS via an EKG sweep
Measured: Week 19
Heart rate
Measure heart rate and heart rate variability with VNS
Measured: Baseline, Week 6 and Week 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant DepressionStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Wallace Austelle, Stanford University
- Investigators
- Christopher Austelle, MD, Study director, Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310381
- Sponsor's protocol ID
- 80038
- Status last verified
- Dec 2025
- First submitted
- 19 Sep 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vagus Nerve Stimulation (VNS) Electroencephalogram (EEG) Protocol Supplement
- ClinicalTrials.gov ID
- NCT07310381
- Acronym / sponsor ID
- 80038
- Conditions
- Treatment Resistant Depression
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants implanted with VNS | Other | Device: Vagus Nerve StimulationParticipants receiving vagus nerve stimulation through an implanted Vagus Nerve Stimulation Device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vagus Nerve StimulationParticipants receiving vagus nerve stimulation through an implanted Vagus Nerve Stimulation Device. | Device | Participants implanted with VNS |
Primary outcome
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katina Marchione contact
Christopher Austelle, MD study director
Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Vagus Nerve Stimulation in people with Treatment Resistant Depression, run by Stanford University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Irakli Kaloiani (650-800-6920, ikalo@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gamma and theta band phase-amplitude coupling (time frame: Baseline, Week 6 and Week 19). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.