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Device

Deep Brain Stimulation for Depression (PReSiDio Trial)

N/A

Recruiting

Led By Andrew Krystal, MD, MS

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Willing and able to undergo invasive brain recording/stimulation study

Meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnostic criteria for Major Depressive Disorder (MDD) without psychosis based on a Structured Clinical Interview for DSM-V (SCID) with current episode ≥ 2 years that is treatment- resistant (4 adequate trials (including ECT), 3 classes of medications, one augmentation strategy, psychotherapy) as measured by the antidepressant treatment history form (ATHF).

Must not have

History of seizures

Inability to give consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at the end of stage 2 (up to 1.5 year duration)

Summary

This trial is testing a new way to treat depression by altering brain activity with electrical stimulation. The device is FDA approved for epilepsy, and researchers will be measuring whether it helps reduce depression symptoms.

Who is the study for?

This trial is for adults aged 22-70 with major depression that hasn't improved after trying multiple treatments, including medication, psychotherapy, and ECT. Participants must have a consistent history of depression symptoms and not be planning any changes to their current medication regimen during the study. They should be able to attend research visits, perform at-home protocols, speak English, and provide informed consent.

What is being tested?

The trial is testing a personalized brain stimulation device called NeuroPace RNS System—approved for epilepsy—to see if it can safely treat major depression. It involves surgically implanting the device to measure brain activity related to depression and using electrical impulses to potentially alter this activity.

What are the potential side effects?

Potential side effects may include discomfort or complications from surgery, infection risk from implanted hardware, possible headaches or scalp pain post-surgery, and unknown risks associated with altering brain activity through electrical stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am willing and able to participate in a study involving brain recording/stimulation.

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I have been diagnosed with long-term depression without psychosis and treatments haven't worked.

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I am between 22 and 70 years old.

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I have been diagnosed with long-term depression without psychosis and treatments haven't worked.

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I stopped ECT because it didn't work or the side effects were too bad.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of seizures.

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I am unable to understand and give consent for treatment.

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I live alone and do not have anyone to care for me after leaving the hospital.

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I have been diagnosed with a specific mental health condition other than depression or generalized anxiety.

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I have serious health issues that could make surgery risky.

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I have been diagnosed with fibromyalgia or chronic fatigue syndrome.

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I have had brain surgery or a device implanted for brain stimulation.

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I might need electroconvulsive therapy during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at the end of stage 2 (up to 1.5 year duration)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at the end of stage 2 (up to 1.5 year duration)

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at the end of stage 2 (up to 1.5 year duration) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

change in MADRS score

Secondary study objectives

change in Montgomery Asberg Depression Rating Scale (MADRS) score after 1 year

difference in Hamilton Depression Rating Scale (HAMD-17) score

difference in Hamilton Depression Rating Scale (HAMD-17) score after 1 year

+2 more

Other study objectives

Achievement of Long-Term Symptom Control

Biomarker identification in Stage 1

Non-inferiority of closed loop vs open-loop intermittent stimulation therapy and sham stimulation

+5 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Arm 1: Intervention (stimulation ON)Experimental Treatment1 Intervention

This is a crossover trial. Each patient will receive 6 wks of stimulation ON (arm 1), stimulation OFF (arm 2), and Stimulation ON Active Control (sham biomarker) (arm 3) in random order. After 6 months of intervening therapy, this 3-period crossover study will be repeated.

Group II: Arm 3: Active Control (stimulation ON triggered by sham biomarker)Active Control1 Intervention

This is a crossover trial. Each patient will receive 6 wks of stimulation ON (arm 1), stimulation OFF (arm 2), and stimulation ON Active Control (sham biomarker) (arm 3) in random order. After 6 months of intervening therapy, this 3-period crossover study will be repeated.

Group III: Arm 2: Sham Control (stimulation OFF)Placebo Group1 Intervention

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