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Deep Brain Stimulation for Treatment-Resistant Depression
N/A
Recruiting
Research Sponsored by Helen Mayberg, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and up to 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial uses a device to send electrical signals to a specific brain area in patients with severe depression that hasn't improved with other treatments. The goal is to see if this can help reduce their symptoms by resetting brain activity. The study will monitor changes in brain signals and patient symptoms.
Who is the study for?
This trial is for adults aged 25-70 living in the New York area with Major Depressive Disorder (MDD) that hasn't improved after trying at least four different treatments. They should be experiencing a severe depressive episode lasting two years or have had more than three episodes. Participants must be able to follow study procedures and give written consent.
What is being tested?
The trial tests Deep Brain Stimulation (DBS) using the Medtronic Percept PC system on patients with treatment-resistant depression. It involves placing electrodes in the brain and stimulating it to potentially alleviate symptoms. The study also aims to identify biomarkers related to DBS effectiveness.
What are the potential side effects?
Potential side effects may include discomfort from surgery, risk of infection, headache, confusion, speech problems, and changes in mood or behavior due to brain stimulation. Side effects can vary based on individual responses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and up to 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Hamilton Depression Rating Scale (HDRS) score
Secondary study objectives
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Deep Brain Stimulation (DBS) for Treatment Resistant DepressionExperimental Treatment1 Intervention
Open label active Deep Brain Stimulation (DBS)
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Who is running the clinical trial?
Helen Mayberg, MDLead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I need anticoagulant therapy that can't be stopped for surgery.I do not have any major neurological disorders or unstable illnesses.I cannot have general anesthesia, neurosurgery, or an MRI.I have depression that hasn't improved after trying at least four different treatments.I am between 25 and 70 years old.I have been diagnosed with Major Depressive Disorder without psychosis.I have been depressed for at least 2 years or had more than 3 depressive episodes.I have not attempted suicide nor had serious thoughts of doing so in the recent past.I have been depressed for at least two years or have had more than 3 depressive episodes.
Research Study Groups:
This trial has the following groups:- Group 1: Deep Brain Stimulation (DBS) for Treatment Resistant Depression
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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