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~2 spots leftby Aug 2026

Deep Brain Stimulation for Depression

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen bySameer Sheth, PhD, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Baylor College of Medicine

Must be taking: Antidepressants

Must not be taking: Anticoagulants

Disqualifiers: Psychotic disorder, Bipolar, Substance use, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The goal of the study is to address the unmet need of TRD patients by identifying brain networks critical for treating depression and to use next generation precision DBS with steering capability to engage these targeted networks. The study's goal will be achieved through 3 specific aims: 1. Demonstrate device capability to selectively and predictably engage distinct brain networks 2. Delineate depression-relevant networks and demonstrate behavioral changes with network-targeted stimulation 3. Demonstrate that chronic DBS using steered, individualized targeting is feasible and safe for reducing depressive symptoms

Will I have to stop taking my current medications?

The trial requires that you have a stable antidepressant medication regimen for the month before surgery, so you may not need to stop your current medications if they are stable. However, if you are on chronic anticoagulant or anti-platelet agents, you may need to stop them for at least 2.5 weeks around the time of surgery.

What data supports the effectiveness of the treatment Directional Deep Brain Stimulation for Depression?

Directional Deep Brain Stimulation (dDBS) has shown effectiveness in treating movement disorders like Parkinson's disease by improving symptoms and reducing medication needs, with minimal side effects. This suggests potential benefits for depression, as dDBS can precisely target brain areas, possibly enhancing therapeutic effects while minimizing adverse effects.¹ ² ³ ⁴ ⁵

Is deep brain stimulation generally safe for humans?

Deep brain stimulation (DBS), including directional DBS, is generally considered safe and has been used for various conditions. It can reduce side effects by targeting specific brain areas more precisely, which helps avoid affecting nearby structures.¹ ² ³ ⁴ ⁶

How is the treatment Directional Deep Brain Stimulation unique for depression?

Directional Deep Brain Stimulation (DBS) is unique because it allows for precise targeting of brain areas by steering the electric current, which can improve the therapeutic effect and reduce side effects compared to traditional DBS.¹ ² ³ ⁴ ⁷

Research Team

Sameer Sheth, PhD, MD

Principal Investigator

Baylor College of Medicine

Eligibility Criteria

This trial is for adults aged 22-70 with major depressive disorder (MDD) who haven't improved after trying at least four different depression treatments and ECT or psychotherapy. They must have a stable medication regimen, normal brain MRI, no bipolar or certain personality disorders, no recent substance abuse, and not be pregnant.

Inclusion Criteria

I have been diagnosed with major depression as my main health issue.

Modified mini-mental state examination (MMSE) score ≥ 24

My chronic illness has lasted 2 years or more, or I've had it at least twice in my life.

See 13 more

Exclusion Criteria

Alcohol or substance use disorder within 6 months, excluding nicotine

I have a health condition that makes surgery risky for me.

I cannot have surgery due to a medical condition like an infection.

See 15 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Subacute Neurophysiological Monitoring

Subacute invasive neurophysiological monitoring to gain insight into the networks underlying depression symptomatology

4-8 weeks

Treatment

Chronic DBS using steered, individualized targeting to reduce depressive symptoms

54 to 60 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

Directional Deep Brain Stimulation (Device)

Trial OverviewThe study tests a new type of Deep Brain Stimulation (DBS) that directs electrical currents to specific brain networks linked to depression. It aims to show this method can change behavior by targeting these networks and is safe for long-term use in reducing symptoms of severe depression.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Directional Deep Brain StimulationExperimental Treatment1 Intervention

Directional Deep Brain Stimulation is already approved in Canada for the following indications:

Approved in Canada as Deep Brain Stimulation for:

Parkinson's disease
Essential tremor
Dystonia
Obsessive-compulsive disorder
Epilepsy

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:

Baylor College of MedicineHouston, TX

University of Texas SouthwesternDallas, TX

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Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1044

Patients Recruited

6,031,000+

University of Texas

Collaborator

Trials

193

Patients Recruited

143,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporal Stability of Lead Orientation in Directional Deep Brain Stimulation.Dembek, TA., Asendorf, AL., Wirths, J., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Study for Considering Subthalamic Nucleus Anatomy during Stimulation Using Directional Leads.Asahi, T., Ikeda, K., Yamamoto, J., et al.[2020]

In a study of 74 patients with Parkinson's disease and essential tremor, 39-68% of patients with Parkinson's and 50-72% with essential tremor utilized directional deep brain stimulation (d-DBS) over 36 months to improve symptom control and reduce side effects.

Directional stimulation was preferred initially in essential tremor patients due to simpler programming, but as experience grew, more Parkinson's patients also benefited from d-DBS, highlighting its potential for better therapeutic outcomes compared to traditional omnidirectional stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Clinical Experience with Directional Deep Brain Stimulation Programming: A Retrospective Review.Karl, JA., Joyce, J., Ouyang, B., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Institutional Experience of Directional Deep Brain Stimulation and a Review of the Literature.Mishra, A., Unadkat, P., McBriar, JD., et al.[2023]

In a study of 53 patients with advanced Parkinson's disease, directional deep brain stimulation (dDBS) led to a significant 44% improvement in motor symptoms (measured by UPDRS-III) and a 43% reduction in medication dosage over 6 months, with sustained benefits at 18 months.

dDBS not only improved motor symptoms but also alleviated non-motor symptoms, demonstrating its effectiveness and safety in real-life clinical settings, with minimal adverse effects reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-Life Experience on Directional Deep Brain Stimulation in Patients with Advanced Parkinson's Disease.Koivu, M., Scheperjans, F., Eerola-Rautio, J., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical Strategy for Directional Deep Brain Stimulation.Masuda, H., Shirozu, H., Ito, Y., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The actual use of directional steering and shorter pulse width in selected patients undergoing deep brain stimulation.Zitman, FMP., Janssen, A., van der Gaag, NA., et al.[2022]