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Deep Brain Stimulation for Depression (PReSiDio Trial)
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.
PReSiDio Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPReSiDio Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PReSiDio Trial Design
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Who is running the clinical trial?
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- I am willing and able to participate in a study involving brain recording/stimulation.My mental health medication has been stable for the last 4 weeks.I stopped ECT because it didn't work or the side effects were too bad.I have a history of seizures.I am between 22 and 70 years old.I have been diagnosed with long-term depression without psychosis and treatments haven't worked.I cannot stop taking blood thinners for surgery.I have been diagnosed with long-term depression without psychosis and treatments haven't worked.I have been diagnosed with long-term depression without psychosis and treatments haven't worked.My mental health medication has been stable for the last 4 weeks.I am unable to understand and give consent for treatment.My depression rating changes by at least 2 points when tested multiple times over 3 days.I stopped ECT because it didn't work or the side effects were too bad.I live alone and do not have anyone to care for me after leaving the hospital.I have been diagnosed with a specific mental health condition other than depression or generalized anxiety.I have serious health issues that could make surgery risky.I have been diagnosed with fibromyalgia or chronic fatigue syndrome.I have had brain surgery or a device implanted for brain stimulation.I might need electroconvulsive therapy during the study.My mental health medication has been stable for the last 4 weeks.My depression rating changes by at least 2 points when tested multiple times over 3 days.You are willing to undergo a study that involves invasive recording or stimulation of your brain.I stopped ECT because it didn't work or the side effects were too bad.You are comfortable and able to participate in a study that involves invasive brain recording or stimulation.I am between 22 and 70 years old.I am between 22 and 70 years old.My depression severity changes, as shown by a test score variation.I can attend all research visits and follow the study plan at home.
- Group 1: Arm 2: Sham Control (stimulation OFF)
- Group 2: Arm 3: Active Control (stimulation ON triggered by sham biomarker)
- Group 3: Arm 1: Intervention (stimulation ON)
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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!"
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."
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."
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."
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