What side effects are associated with this type of intervention?

Common treatments for Major Depressive Disorder that are similar to Deep Brain Stimulation include Electroconvulsive Therapy (ECT) and Transcranial Magnetic Stimulation (TMS). ECT can cause side effects such as memory loss, confusion, and physical side effects like headaches and muscle aches. TMS is generally well-tolerated but can lead to scalp discomfort, headaches, and, in rare cases, seizures. Both treatments are considered when other interventions have failed, and their side effects are usually manageable with proper medical supervision.

What prior FDA approvals exist?

The FDA has approved several neuromodulation treatments for Major Depressive Disorder. Transcranial Magnetic Stimulation (TMS) was approved in 2008 for patients who have not responded to antidepressant medications. Vagus Nerve Stimulation (VNS) received FDA approval in 2005 for treatment-resistant depression. Both TMS and VNS involve electrical stimulation to modulate neural activity, similar to the Deep Brain Stimulation (DBS) being studied in clinical trials for treatment-resistant depression.

What other types of research exist?

Promising, novel alternatives to Deep Brain Stimulation for Major Depressive Disorder include Transcranial Magnetic Stimulation (TMS), which has shown efficacy in reducing depressive relapses, and Transcranial Direct Current Stimulation (tDCS), which has demonstrated mood-elevating effects and cognitive enhancement in some studies. Vagus Nerve Stimulation (VNS) is another option, with evidence supporting its use in treatment-resistant depression. These alternatives offer non-invasive or less invasive options compared to DBS.

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Procedure

DBS for Depression

Phase 1

Recruiting

Led By Albert J Fenoy, MD

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

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

Must have

Age 22 - 70 years

Major Depression Disorder (MDD) diagnosed by Structured Clinical Interview for DSM-V (SCID I/DSM-V)

Must not have

Subject is on anticoagulant medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test if deep brain stimulation can help people with treatment-resistant depression. The device is implanted in the brain and sends electrical signals to control mood. Researchers will monitor patients over several years to see if it reduces depression symptoms. Deep brain stimulation (DBS) has a decades-long history in psychiatric neurosurgery and has shown promise for treatment-resistant depression.

Who is the study for?

This trial is for adults aged 22-70 with severe, treatment-resistant depression. They must have tried multiple medications, psychotherapy, and possibly ECT without success. Participants need to be stable on their current meds and willing to be monitored over 5 years. Exclusions include those with psychosis history, unstable living situations, certain medical conditions or contraindications for surgery.

What is being tested?

Researchers are testing a Medtronic SenSight Directional DBS lead device implanted in participants to treat resistant depression. Over five years, the device's effectiveness will be assessed by turning it off at random times without participants' knowledge and comparing their questionnaire scores during these periods.

What are the potential side effects?

Potential side effects may include discomfort from the implantation procedure of the DBS device, headache or infection at the surgical site. There might also be risks related to hardware malfunction or adverse changes in mood or behavior due to stimulation.

Eligibility Criteria

Inclusion Criteria

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

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I am between 22 and 70 years old.

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I have been diagnosed with Major Depression Disorder.

Exclusion Criteria

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

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I am currently taking medication to prevent blood clots.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Montgomery-Asberg Depression Rating Scale (MADRS)

Secondary study objectives

Clinical Global Impressions (CGI) rated severity

Global Assessment of Functioning (GAF) rated functional impairment

Measuring MADRS during discontinuation cross over weeks

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Discontinuation Phase Group 2Experimental Treatment1 Intervention

Patients will be randomized into two groups for crossover treatment analysis of different parameter settings for six weeks.

Group II: Discontinuation Phase Group 1Experimental Treatment1 Intervention

Patients will be randomized into two groups for crossover treatment analysis of different parameter settings for six weeks.

0 / 3Eligibility 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

The most common treatments for Major Depressive Disorder (MDD) that involve neuromodulation include Electroconvulsive Therapy (ECT), Repetitive Transcranial Magnetic Stimulation (rTMS), and Transcranial Direct Current Stimulation (tDCS). ECT induces controlled seizures to reset neural circuits, rTMS uses magnetic fields to stimulate specific brain areas, and tDCS applies a low electrical current to modulate brain activity. These treatments target brain regions involved in mood regulation, such as the prefrontal cortex, to alleviate depressive symptoms. This is particularly important for MDD patients who do not respond to traditional medications, offering alternative pathways to manage and potentially improve their condition.