5 Participants NeededMy employer runs this trial

Deep Brain Stimulation for Bipolar Depression

ER
AV
Overseen ByAvantika Vardhan
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Icahn School of Medicine at Mount Sinai
Must be taking: Mood stabilizers
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist individuals with bipolar disorder who have not found relief from depression with other treatments. Researchers are testing the Medtronic Percept PC DBS system, a device that uses deep brain stimulation to manage depression and prevent mood swings by sending electrical impulses to specific brain areas. To ensure the treatment's safety, the trial monitors brain activity to track depression and predict mania. Suitable candidates for this trial have Bipolar I Disorder, have experienced depression for at least a year despite trying several treatments, and have stable mood control without recent manic episodes. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for those seeking new solutions.

What prior data suggests that this Deep Brain Stimulation technique is safe for treating bipolar depression?

A previous study found that Deep Brain Stimulation (DBS) was generally well-tolerated by most patients. DBS involves placing small wires in specific brain areas to treat conditions like Parkinson's disease and, more recently, some mental health issues. For bipolar disorder, the target area is the Subcallosal Cingulate (SCC) region of the brain. Although using DBS for bipolar disorder is new, the technique has been applied to other conditions before.

Past studies on DBS have shown that side effects can occur, often mild, such as headaches or temporary mood changes. Serious side effects are less common but may include infections at the surgery site or device-related issues. The Medtronic Percept PC DBS system has already received FDA approval for other uses, indicating a certain level of safety. However, each person's experience with DBS can vary. Participants should discuss potential risks and benefits with the research team before joining a trial.12345

Why are researchers excited about this trial?

Most treatments for bipolar depression, like mood stabilizers and antipsychotics, work by altering neurotransmitter levels. But the Medtronic Percept PC DBS system works differently, targeting specific brain areas directly through electrical stimulation. This deep brain stimulation method is unique because it provides continuous local field potential monitoring from the subcallosal cingulate and amygdala, potentially allowing for more precise regulation of brain activity related to mood. Researchers are excited about this approach because it offers a new way to manage symptoms for those who might not respond well to traditional medications.

What evidence suggests that this DBS system is effective for bipolar depression?

Research has shown that Deep Brain Stimulation (DBS) can help treat severe depression. Studies found that 40-60% of people with depression experienced lasting relief from their symptoms with DBS. Specifically, after just two weeks of treatment, more than half of the patients showed a 47% reduction in their depression scores. Additionally, a long-term study revealed that 71% of patients with severe depression improved. This trial will specifically evaluate the use of DBS for bipolar depression, suggesting it could be a promising treatment option for participants.678910

Who Is on the Research Team?

HM

Helen Mayberg, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for adults with Bipolar I Disorder who have severe depression that hasn't improved with standard treatments. Participants should be able to undergo brain surgery and follow study procedures. People with certain medical or psychiatric conditions may not qualify.

Inclusion Criteria

Under care of treating psychiatrist willing to collaborate with study team
Hamilton Depression Rating Scale-17 (HDRS-17) score ≥20 at screening and baseline
Stable control of mania for a minimum of 1 year
See 13 more

Exclusion Criteria

Substance Use Disorder without sustained remission (less than 12 months)
History of borderline or severe personality disorder interfering with participation
BMI >35 and/or CRP >3
See 25 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive open label active bilateral Subcallosal Cingulate (SCC) Deep Brain Stimulation (DBS) with ongoing local field potential monitoring from the SCC and amygdala

1 year
Weekly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Medtronic Percept PC DBS system

Trial Overview

The study tests deep brain stimulation (DBS) using the Medtronic Percept PC system, targeting a specific brain area (subcallosal cingulate) in people with treatment-resistant bipolar depression. The device also monitors brain signals to track mood changes.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Participants with Bipolar disorderExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials
933
Recruited
579,000+

Citations

Medtronic Percept PC DBS system의 양극성 우울증 및 제1형 양극성 ...

This study addresses a critical unmet need in the treatment of bipolar disorder by investigating whether Subcallosal Cingulate (SCC) Deep Brain Stimulation ...

New Study Resuscitates Potential of Deep Brain ...

patients with severe depression demonstrated response rates of 5% to 60%. Over an 8-year period, the majority of patients (71%; n=20) ...

the mount sinai health system

The purpose of this research study is to use a device, the Percept PC (Medtronic, Inc), to measure changes in the electrical patterns in your brain while you ...

Identification of a Personalized Intracranial Biomarker ... - PMC

The patient underwent standard stimulation programming with partial response in OCD symptoms (reduction in Y-BOCS from 36 to 25; 31% improvement) ...

Long-Term Success with Deep Brain Stimulation for Treatment ...

After just two weeks of active DBS, over half the patients saw a 47% reduction in depression scores (as measured by the Montgomery-Åsberg ...

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