What side effects are associated with this type of intervention?

Common treatments for depression that involve neuromodulation, such as Deep Brain Stimulation (DBS), Transcranial Magnetic Stimulation (TMS), and Electroconvulsive Therapy (ECT), have various side effects. DBS can cause infection, hemorrhage, confusion, or seizures, though severe adverse effects are uncommon. TMS may lead to headaches, scalp discomfort, or, rarely, seizures. ECT is associated with short-term memory loss, confusion, and physical side effects like muscle aches. These treatments are generally considered when other therapies have failed, and their side effects are often manageable under medical supervision.

What prior FDA approvals exist?

The FDA has approved several neuromodulation treatments for depression. Transcranial Magnetic Stimulation (TMS) is an FDA-approved non-invasive procedure that uses magnetic fields to stimulate nerve cells in the brain and is used for treatment-resistant depression. Vagus Nerve Stimulation (VNS) is another FDA-approved treatment that involves electrical stimulation of the vagus nerve to alleviate symptoms of depression. While Deep Brain Stimulation (DBS) for depression is still considered experimental and not yet FDA-approved, it shows promise in resetting brain networks to treat treatment-resistant depression.

What other types of research exist?

Promising novel alternatives to Deep Brain Stimulation for depression include: 1) Transcranial Direct Current Stimulation (tDCS), which has shown potential in improving mood and cognitive function in depression. 2) Repetitive Transcranial Magnetic Stimulation (rTMS), which has been effective in reducing depressive symptoms and is used as both an acute and maintenance treatment. 3) Vagus Nerve Stimulation (VNS), which has demonstrated long-term benefits in treatment-resistant depression. 4) Electroconvulsive Therapy (ECT), which remains a highly effective treatment for severe depression, particularly when rapid response is needed.

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Device

Deep Brain Stimulation for Treatment-Resistant Depression

N/A

Waitlist Available

Research Sponsored by Helen Mayberg, MD

Eligibility Criteria Checklist

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

Must have

Primary psychiatric diagnosis of Major Depressive Disorder (MDD), either single episode or recurrent type, without psychotic features, currently experiencing a Major Depressive Episode (MDE), as diagnosed by Structured Clinical Interview for DSM IV-TR (SCID). Two independent psychiatrists will confirm the diagnosis

Confirmed to have treatment-resistant depression (TRD). Treatment-resistance will be defined as:

Must not have

Conditions requiring anticoagulant therapy which cannot be discontinued for the perioperative period, as required

Contraindications for general anesthesia, neurosurgery, or an MRI scan

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline; after 6 months of continuous active stimulation; after 1 year of continuous active stimulation

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include risks associated with neurosurgery and general anesthesia, changes in mood or behavior due to electrical stimulation of the brain, discomfort from regular monitoring procedures like EEGs, and possible interference with other implanted devices.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with Major Depressive Disorder without psychosis.

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My depression hasn't improved after trying two different treatments.

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I am between 25 and 70 years old.

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I have been depressed for at least 2 years or had more than 3 depressive episodes.

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I have been depressed for at least 2 years or had more than 3 depressive episodes.

Exclusion Criteria

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

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

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I cannot have general anesthesia, neurosurgery, or an MRI.

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I do not have any major neurological disorders or unstable illnesses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline; after 6 months of continuous active stimulation; after 1 year of continuous active stimulation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline; after 6 months of continuous active stimulation; after 1 year of continuous active stimulation

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; after 6 months of continuous active stimulation; after 1 year of continuous active stimulation for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Mental Depression

Secondary study objectives

Mental Depression

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)Experimental Treatment1 Intervention

Open label active Deep Brain Stimulation (DBS)

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for depression include pharmacotherapy, psychotherapy, and neuromodulation techniques. Pharmacotherapy typically involves antidepressants that modulate neurotransmitters like serotonin and norepinephrine to improve mood. Psychotherapy, such as Cognitive Behavioral Therapy (CBT), helps patients change negative thought patterns. Neuromodulation techniques, including Electroconvulsive Therapy (ECT) and Transcranial Magnetic Stimulation (TMS), use electrical or magnetic stimulation to alter brain activity. Deep Brain Stimulation (DBS) specifically targets the subcallosal cingulate to reset dysfunctional brain networks, offering potential relief for treatment-resistant depression. Understanding these mechanisms is crucial for patients as it helps tailor treatments to individual needs and improves the likelihood of successful outcomes.