Deep Brain Stimulation for Depression

Recruiting in Palo Alto (17 mi)

Overseen byJair C Soares, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: The University of Texas Health Science Center, Houston

No Placebo Group

Trial Summary

What is the purpose of this trial?

We propose a clinical study of medial forebrain bundle DBS as a treatment in 20 patients with treatment refractory depression (TRD). Data from the University of Bonn indicates that surgical lesions of the medical forebrain bundle can produce therapeutic benefits in patients with depressive disorders, and suggest that DBS at the same site may also reduce symptomatology in these TRD patients (Schaepfer, 2013). Depression affects up to 10% of the US population and of those at least 10-15% do not benefit from therapies hence why we must explore new treatments. The Percept™ PC system manufactured by Medtronic Neurological will be used in this study. Study subjects will be between the ages of 22 and 70 years of age and suffer from TRD, have failed multiple treatment regimens, including ECT, and remain symptomatic. Those identified as TRD patients will then be enrolled in a clinical pilot study investigating DBS, targeting the MFB.

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

Eligibility Criteria

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.

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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)

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Treatment Details

Interventions

Deep Brain Stimulation Model 3387 Model 3389 (Device)

Trial OverviewThe 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.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Deep Brain StimulationExperimental Treatment1 Intervention

Device implantation (Deep Brain Stimulation Model 3387 Model 3389)