Treatment Resistant Depression
Conditions
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.
Interventions
DEVICEVagus Nerve Stimulation
Participants receiving vagus nerve stimulation through an implanted Vagus Nerve Stimulation Device.
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participants must be at least 18 years old. 2. 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. 3. Proficiency in English sufficient to complete questionnaire and follow instructions during fMRI assessments and iTBS interventions. 4. Willingness to comply with all study procedures and the ability to communicate with study personnel about adverse events and other clinically important information 5. 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. 6. 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. 7. Access to ongoing psychiatric care before and after completion of the study. 8. In good general health, as evidenced by medical history 9. Agreement to adhere to Lifestyle Considerations throughout study duration.
Exclusion criteria
1. Participant is pregnant 2. Participant does not speak or read English 3. Any other clinical reasons deemed by the investigator of the study for which the participant would not be an appropriate candidate for the study. 4. Contraindication to MRI (ferromagnetic metal in their body) 5. Contraindication to EEG 6. Medication Contraindications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gamma and theta band phase-amplitude coupling | 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
| Measure | Time frame | Description |
|---|---|---|
| Resting state functional connectivity between the left dorsolateral prefrontal cortex and subgenual anterior cingulate cortex | Baseline, Week 6 and Week 19 | Measurement of changes in resting state functional connectivity between the left dorsolateral prefrontal cortex and subgenual anterior cingulate cortex with chronic VNS using fMRI. |
| Heart brain coupling | Week 19 | Measurement of heart brain coupling (heart rate entrainment in response to trains of intermittent theta burst stimulation) with VNS via an EKG sweep |
| Heart rate | Baseline, Week 6 and Week 19 | Measure heart rate and heart rate variability with VNS |
Other
| Measure | Time frame | Description |
|---|---|---|
| Galvanic Skin Response | Baseline, Week 6 and Week 19 | Measure the changes in sweat gland activity that affects the skin's electrical properties with VNS |
| Blood pressure | Baseline, Week 6 and Week 19 | Measure the changes in blood pressure with VNS |
| Respiratory rate | Baseline, Week 6 and Week 19 | Measure the changes in respiratory rate with chronic VNS. |
| Pupil diameter | Baseline, Week 6 and Week 19 | Measure the changes in pupil diameter with chronic VNS using pupillometry. |
Contacts
Primary ContactIrakli Kaloiani
Backup ContactKatina Marchione
Outcome results
None listed