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Device

Deep Brain Stimulation for Depression (PReSiDio Trial)

N/A
Recruiting
Led By Andrew Krystal, MD, MS
Research Sponsored by Andrew Krystal
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
If patient is on a regimen of psychotropic medication, no changes in this regimen should be made during the 4 weeks prior to entry into and the duration of the study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at the end of stage 2 (up to 1.5 year duration)
Awards & highlights

PReSiDio Trial 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.Check my eligibility
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.See study design
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.

PReSiDio Trial 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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My mental health medication has been stable for the last 4 weeks.
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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.
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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 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.
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My mental health medication has been stable for the last 4 weeks.
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I stopped ECT because it didn't work or the side effects were too bad.
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I am between 22 and 70 years old.
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I am between 22 and 70 years old.
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My depression severity changes, as shown by a test score variation.
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I can attend all research visits and follow the study plan at home.

PReSiDio Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
change in MADRS score
Secondary outcome measures
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 outcome measures
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

PReSiDio 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
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.

Find a Location

Who is running the clinical trial?

Andrew KrystalLead Sponsor
1 Previous Clinical Trials
University of California, San FranciscoLead Sponsor
2,496 Previous Clinical Trials
11,933,837 Total Patients Enrolled
71 Trials studying Depression
28,816 Patients Enrolled for Depression
Andrew Krystal, MD, MSPrincipal InvestigatorUniversity of California, San Francisco
3 Previous Clinical Trials
79 Total Patients Enrolled
2 Trials studying Depression
65 Patients Enrolled for Depression

Media Library

NeuroPace Responsive Neurostimulation (RNS) System (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04004169 — N/A
Depression Research Study Groups: Arm 2: Sham Control (stimulation OFF), Arm 3: Active Control (stimulation ON triggered by sham biomarker), Arm 1: Intervention (stimulation ON)
Depression Clinical Trial 2023: NeuroPace Responsive Neurostimulation (RNS) System Highlights & Side Effects. Trial Name: NCT04004169 — N/A
NeuroPace Responsive Neurostimulation (RNS) System (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04004169 — N/A
Depression Patient Testimony for trial: Trial Name: NCT04004169 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this study require participants to be over 25 years old?

"This particular trial is only enrolling patients aged 22-70. Out of the 206 trials that exist for people under 18 and 1003 trials for those over 65, this is the one you want to be a part of!"

Answered by AI

Are new enrollees still being accepted into the research?

"The online clinical trials database reports that this study is still recruiting patients. This trial was originally posted on July 18th, 2019 and updated as recently as January 13th, 2021."

Answered by AI

How can I sign up to be a part of this clinical research?

"The ideal candidate for this study suffers from melancholia and is between 22 and 70 years old. So far, the research team has recruited 12 patients."

Answered by AI

How many people are included in this investigation?

"Yes, according to the information on clinicaltrials.gov, this study is still looking for patients. The trial was first posted on 7/18/2019 and was last updated on 1/13/2021. They are hoping to enroll 12 patients at 1 location."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
New York
California
Other
How old are they?
65+
18 - 65
What site did they apply to?
University of California, San Francisco
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2

Why did patients apply to this trial?

Sick of taking tons of medication with little effectiness. Looking for help.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
~7 spots leftby Jun 2030