Deep Brain Stimulation for Depression

Overseen By Bashar Asir, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Must be taking: Psychotropic medications

Must not be taking: Anticoagulants

Disqualifiers: Psychotic disorders, Neurological disorders, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test deep brain stimulation (DBS) as a potential treatment for individuals with treatment-resistant depression (TRD), a severe form of depression unresponsive to standard treatments. The study will explore whether DBS can reduce depression symptoms by targeting a specific brain area that may influence mood. Participants should have tried multiple depression treatments without success, including therapies like electroconvulsive therapy (ECT), and still experience symptoms. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for TRD.

Will I have to stop taking my current medications?

No, you will not have to stop taking your current medications. Participants must be on a stable drug regimen of psychotropic medication for at least 6 weeks before entering the study and cannot change their medication during the study.

What prior data suggests that this device is safe for treating treatment refractory depression?

Research shows that deep brain stimulation (DBS) could be a promising option for people whose depression hasn't improved with other treatments. Data from the University of Bonn indicates that targeting the medial forebrain bundle can help reduce depression symptoms. Importantly, studies found that using DBS electrodes, specifically Medtronic models 3387 and 3389, did not cause common side effects like confusion or worsening depression.

DBS has been tested in other trials and has demonstrated its ability to ease depression symptoms over time. While all medical procedures carry potential risks, most patients have tolerated DBS well. For those considering joining a clinical trial for DBS, these findings suggest it is generally safe and well-tolerated, with no major side effects reported in similar studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for depression, such as antidepressants and psychotherapy, Deep Brain Stimulation (DBS) targets specific brain areas directly through implanted devices. Researchers are excited about DBS because it offers a new way to modulate brain activity by delivering electrical impulses, potentially providing relief for those who haven't responded to traditional therapies. This precision-targeted approach aims to alter brain circuits associated with mood regulation, offering hope for faster and possibly more effective results in managing severe depression.

What evidence suggests that Deep Brain Stimulation is effective for treatment refractory depression?

Research has shown that deep brain stimulation (DBS), which participants in this trial will receive, can help reduce symptoms in people with treatment-resistant depression. Specifically, targeting the medial forebrain bundle has shown promising results, with studies indicating significant antidepressant effects. Data from the University of Bonn supported that surgery in this brain area can provide therapeutic benefits. Additionally, DBS has improved various aspects of depression, although improvements in sleep problems may take longer. Overall, evidence suggests DBS could be a good option for those who haven't responded to other treatments. ^{1 2 4 5 6}

Who Is on the Research Team?

Joao Quevedo, MD, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Giovana Zunta Soares, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Jair C Soares, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for adults aged 22-70 with severe, treatment-resistant depression (TRD) who have tried multiple medications, psychotherapy, and possibly ECT without success. Participants must be in generally good health and not currently abusing substances. Pregnant women or those at risk of pregnancy without effective contraception are excluded.

Inclusion Criteria

Able to give written informed consent

Global Assessment of Function (GAF) score of 45 or less

My depression has recurred 4+ times or lasted 2+ years, starting over 5 years ago.

Exclusion Criteria

I do not have any brain-related health issues like dementia.

I've had surgery to target a specific area in my brain before.

Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Phase

A 1 month period with no stimulation following surgical implantation

4 weeks

Variable Staggered Phase

Blinded stimulation onset starting from 1 month to 3 months post implant, with optimal parameter determination

8 weeks

Initial Chronic Phase

Blinded bilateral stimulation, lasting at least three months

12 weeks

Continuation Phase

Unblinded active bilateral or unilateral stimulation to maximize clinical response

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Deep Brain Stimulation Model 3387 Model 3389

Trial Overview The study tests Deep Brain Stimulation (DBS) using the Percept™ PC system by Medtronic Neurological to target the medial forebrain bundle in patients with TRD. The goal is to see if DBS can reduce depressive symptoms in those who haven't responded to other treatments.

How Is the Trial Designed?

Group I: Deep Brain Stimulation Experimental Treatment 1 Intervention

Device implantation (Deep Brain Stimulation Model 3387 Model 3389)

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02046330

Deep Brain Stimulation (DBS) Therapy for Treatment ... Data from the University of Bonn indicates that surgical lesions of the medical forebrain bundle can produce therapeutic benefits in patients with depressive ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5682606/

a comparison of two targets and long-term follow-up - PMC Our data indicate that, in the long term, both ITP and IC/BST stimulation may alleviate depressive symptoms in patients suffering from TRD.

3. clinicaltrials.gov clinicaltrials.gov/ct2/keydates/NCT02046330

Deep Brain Stimulation (DBS) Therapy for Treatment ... Data from the University of Bonn indicates that surgical lesions of the medical forebrain bundle can produce therapeutic benefits in patients with depressive ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6785007/

Superolateral medial forebrain bundle deep brain ... Short- and long-term antidepressant effects of deep brain stimulation (DBS) in treatment-resistant depression (TRD) have been demonstrated for several brain ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1878747925001011

Deep brain stimulation improves symptoms across all ... Our findings demonstrate that DBS for TRD effectively treats depressive symptoms in all dimensions, although insomnia symptoms may improve at a slower rate.

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/p960009s007b.pdf

summary of safety and effectiveness data - accessdata.fda.gov A description of each of the system components follows. Model 3387/Model 3389 DBS™ Leads. The DBS leads consist of a polyurethane protective ...