Deep Brain Stimulation for Treatment-Resistant Depression

Recruiting in Palo Alto (17 mi)

Overseen byHelen Mayberg, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Helen Mayberg, MD

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial is testing a new device that sends electrical signals to the brain to help people with severe depression who don't respond to usual treatments. The device also records brain activity to understand how the treatment works. The study will involve 10 patients and last for several years. Deep brain stimulation (DBS) has been investigated for a long time as a treatment for severe, treatment-resistant depression, showing potential but requiring further research.

Eligibility Criteria

This trial is for adults aged 25-70 with severe, treatment-resistant Major Depressive Disorder (MDD), who have not responded to multiple treatments including medications and possibly ECT. They must be able to undergo an MRI, live near New York City, and have a caregiver to assist them. Pregnant individuals or those planning pregnancy, people with certain medical conditions or on anticoagulant therapy that can't be stopped are excluded.

Inclusion Criteria

Your overall level of functioning is assessed to be 50 or lower.

Ability to provide written informed consent

I have been diagnosed with Major Depressive Disorder without psychosis.

+13 more

Exclusion Criteria

You have a heart device like a pacemaker or defibrillator that could be affected by the study treatment.

You have a medical condition that requires MRI scans or diathermy treatment.

I need anticoagulant therapy that can't be stopped for surgery.

+6 more

Participant Groups

The study tests the Medtronic Summit RC+S DBS system's ability to alleviate symptoms of severe depression by stimulating a brain region called the subcallosal cingulate. Participants will receive this experimental device implant and their brain activity will be monitored regularly over approximately ten years.

1Treatment groups

Experimental Treatment

Group I: Deep Brain Stimulation (DBS)Experimental Treatment1 Intervention

Open label active Deep Brain Stimulation (DBS)