Frequently Asked Questions

The study is designed to last approximately 2.5 to 3 years if you complete all three stages. 

The eligibility criteria for the "Closed-Loop Deep Brain Stimulation for Treatment Resistant Depression" study are focused on selecting participants who have major depression and have not found adequate relief with current therapies. Specifics of the criteria include:
 

• Diagnosis: Participants must have a diagnosis of major depression.
• Treatment Resistance: Eligibility requires that traditional therapies have been ineffective. A trial of electroconvulsive therapy and at least three types of medication is required to be considered for the study.
• Health Status: Participants must be in suitable physical and mental health for the procedures involved in the study, including brain surgery and brain stimulation.
• Commitment: The study demands a significant time commitment, including multiple visits and stages of participation.
   

The criteria are designed to ensure that the study includes individuals who may benefit most from this innovative approach while also considering safety and the feasibility of participation. 

Other criteria include:

• You can speak and read in English.
• You are between the ages of 22 and 75.
• You have not had any traumatic brain injury, seizures, or other neurologic disorders.
• You must be able to have an MRI – any implanted hardware that is incompatible with MRI would make you ineligible. 

These are just some of the criteria that we use to determine if you are a good fit for the study. If you are interested in the study, we will do a screening phone call with you to help determine if the study would be safe and potentially effective option for you.

If you decide to participate in the study, there are several requirements and stages you will go through:

Initial Preparation: Before the main part of the study begins, you will have several baseline screening visits and will need to see your primary care doctor. You will be asked to consent to medical screening, testing of your neurological functionality, psychiatric assessments, medical and psychiatric history, and brain scans: magnetic resonance imaging (MRI) and computerized tomography (CT). 

Treatment Stages: 
(Stage 1) The first stage of the study involves surgically implanting small, thin wire-like devices (electrodes) in both sides of your brain in regions that regulate mood. You will then spend approximately 11 days inpatient at Moffitt Hospital on the UCSF Parnassus campus, where researchers will test stimulation in different brain regions​​. 
(Stage 2) The second stage will involve a second brain surgery to implant the NeuroPace RNS® System. Researchers will use information from Stage 1 to decide where to implant the electrodes of the RNS System. Over the next ~4-15 months, you will have regular study visits that will be in the clinic, at your home or in a hotel room, or via phone/video call. During these study visits the researchers will A) figure out the brain activity pattern that best represents your depression symptoms and B) find the type of stimulation that is best for your brain. The device is designed to work so that stimulation will happen automatically if it detects a brain activity pattern that is associated with your depression symptoms. After initial testing in clinic, subsequent changes to device settings may occur in-home. Phone or video visits may be used for weekly check-ins and/or following changes to device settings.
(Stage 3) The third stage is about 9 months long and involves turning ON and OFF the intervention. As part of this stage you have 3 periods, each up to 3 months, in which you will have a different setting. In a random order you will have one period of no stimulation, one period of the intervention and one period of active control stimulation (fixed interval stimulation). The remainder of the time you will receive the intervention.
 

Post-Study Options: At the end of stage 3, you will have several options regarding the continuation of the treatment. These include continuing active stimulation at the current settings with the RNS® System, searching for new settings for stimulation, discontinuing stimulation and leaving the device implanted, or having the device removed. If you choose to continue with the RNS® System intervention in the long-term follow-up phase, you will have follow-up appointments every 8 weeks through the end of the battery life, which is predicted to be about 6-12.4 years after placement​​.
 

Option to Withdraw: You have the option to stop participating in the study at any time.

Potential Relief from Depression Symptoms: Participants may experience some relief from their depression symptoms. However, it's important to note that there is also a possibility of receiving no benefit from the treatment because it is still experimental.

Contributing to Medical Knowledge: Participation in this study will help doctors and researchers learn more about how responsive neurostimulation can affect brain activity related to depression. This knowledge is valuable and will be useful in the treatment of future patients with depression.

There are no costs to being in the study. The expense of the surgeries are covered by the study.

Email our team at [email protected] and one of our clinical research coordinators will contact you back by phone or email.