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

NCT07310381 | Not Yet Recruiting

• 1 other identifier: 80038
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study will examine the autonomic, physiologic and neurophysiologic effects of implanted Vagus Nerve Stimulation (VNS) in treatment-resistant depression patients.

Conditions

Treatment Resistant Depression

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline, Week 6 and Week 19

Secondary Outcomes (3)

• 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

Other Outcomes (4)

• Galvanic Skin Response

  Baseline, Week 6 and Week 19

• Blood pressure

  Baseline, Week 6 and Week 19

• Respiratory rate

  Baseline, Week 6 and Week 19

Study Arms (1)

Participants implanted with VNS

OTHER

Participants receiving vagus nerve stimulation through an implanted Vagus Nerve Stimulation Device.

Device: Vagus Nerve Stimulation

Interventions

Vagus Nerve Stimulation DEVICE

Participants receiving vagus nerve stimulation through an implanted Vagus Nerve Stimulation Device.

Participants implanted with VNS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Interventions

Vagus Nerve Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Study Officials

• Christopher Austelle, MD

  Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine

  STUDY DIRECTOR

Central Study Contacts

Irakli Kaloiani

CONTACT

650-800-6920; ikalo@stanford.edu

Katina Marchione

CONTACT

kfmarch@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor, Department of Psychiatry & Behavioral Sciences, Stanford University School of Medicine

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: December 30, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12