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The study will examine the autonomic, physiologic and neurophysiologic effects of implanted Vagus Nerve Stimulation (VNS) in treatment-resistant depression patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants implanted with VNS | Other | Participants receiving vagus nerve stimulation through an implanted Vagus Nerve Stimulation Device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vagus Nerve Stimulation | Device | Participants receiving vagus nerve stimulation through an implanted Vagus Nerve Stimulation Device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 6 and Week 19 |
| Measure | Description | Time Frame |
|---|---|---|
| Galvanic Skin Response | Measure the changes in sweat gland activity that affects the skin's electrical properties with VNS | Baseline, Week 6 and Week 19 |
| Blood pressure | Measure the changes in blood pressure with VNS |
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Irakli Kaloiani | Contact | 650-800-6920 | ikalo@stanford.edu | |
| Katina Marchione | Contact | kfmarch@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Christopher Austelle, MD | Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine | Study Director |
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| ID | Term |
|---|---|
| D061218 | Depressive Disorder, Treatment-Resistant |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D055536 | Vagus Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
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| 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 |
| Week 19 |
| Heart rate | Measure heart rate and heart rate variability with VNS | Baseline, Week 6 and Week 19 |
| Baseline, Week 6 and Week 19 |
| Respiratory rate | Measure the changes in respiratory rate with chronic VNS. | Baseline, Week 6 and Week 19 |
| Pupil diameter | Measure the changes in pupil diameter with chronic VNS using pupillometry. | Baseline, Week 6 and Week 19 |