Deep Brain Stimulation for Depression

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: Illicit drugs

Disqualifiers: Psychotic disorder, Bipolar, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial uses a new method to help patients with severe epilepsy and depression. It records and stimulates specific brain areas to better understand and improve social and emotional brain functions.

Will I have to stop taking my current medications?

The trial requires that participants 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 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 directional deep brain stimulation safe for humans?

Directional deep brain stimulation (DBS) is generally considered safe and has been shown to improve the therapeutic window, which means it can reduce side effects while maintaining benefits. It allows for more precise targeting, potentially minimizing unintended effects on nearby brain areas. ^{1 2 3 4 6}

How is Directional Deep Brain Stimulation different from other treatments 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 treatment's effectiveness and reduce side effects compared to traditional DBS. ^{1 2 3 4 7}

Research Team

Eligibility Criteria

This trial is for men and women aged 22-70 with treatment-resistant depression or epilepsy, who are undergoing intracranial electrode placement. Participants must have a stable mental state, no drug abuse, no severe medical conditions that could interfere with surgery, and not be pregnant. They should have tried multiple depression treatments without success.

Inclusion Criteria

I've had at least 6 weeks of psychotherapy without lasting improvement.

I am between 22 and 70 years old and not pregnant.

My depression symptoms are severe, scoring 27 or higher on the MADRS.

Exclusion Criteria

I have high blood pressure and heart disease.

Any condition that makes the subject a poor candidate

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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo invasive intracranial monitoring and stimulation for treatment-resistant epilepsy and depression

12 weeks

Regular monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Directional Deep Brain Stimulation (Deep Brain Stimulation)

Trial Overview The study tests 'Directional Deep Brain Stimulation' (DBS) using advanced brain recording techniques in patients with resistant epilepsy and depression to understand how the brain processes social and emotional signals. It aims to improve socio-emotional functions by mapping these neural dynamics.

Participant Groups

Group I: TRD Experimental Treatment 1 Intervention

Group II: EMU Active Control 1 Intervention

Patient's behavioral and neural activity via computer tasks and questionnaires are monitored in the Epilepsy Monitoring Unit

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

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Paul Klotman

Baylor College of Medicine

Chief Executive Officer since 2010

MD, PhD

James Versalovic

Baylor College of Medicine

Chief Medical Officer since 2020

MD from Baylor College of Medicine

Findings from Research

In a study of 18 patients with directional deep brain stimulation (DBS) electrodes, the orientation of the leads remained stable over time, with an average change of only -1.1 ± 3.9° from the initial measurement.

This stability suggests that once implanted, the directional leads do not significantly drift in orientation, which is important for optimizing stimulation settings and ensuring consistent therapeutic effects.

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]

In a study involving six parkinsonian patients, directional leads for deep brain stimulation (DBS) showed a low incidence of adverse effects, particularly when stimulating in the posteromedial direction of the subthalamic nucleus (STN).

DBS significantly improved motor function and reduced dyskinesia, as evidenced by a decrease in Unified Parkinson's Disease Rating Scale (UPDRS) scores from 30.2 to 7.2 for motor symptoms and from 3.3 to 0.5 for dyskinesia after treatment.

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]

Directional deep brain stimulation (dDBS) was effectively implemented in 42 patients with movement disorders, showing a significant average reduction of 35.4% in levodopa-equivalent daily dose for Parkinson's disease patients six months post-implantation.

Despite the benefits of dDBS, accurate surgical placement is crucial, as 10 leads in 6 patients required revision due to electrode malposition, highlighting the importance of precision in achieving optimal clinical outcomes.

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]

Directional deep brain stimulation (DBS) using novel leads allows for more precise targeting of electrical stimulation, which can reduce unintended side effects and improve treatment outcomes for drug-resistant involuntary movements.

The complexity of programming these directional leads necessitates new strategies, including image-guided programming and potential future use of local field potentials for optimal stimulation, enhancing the effectiveness of DBS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

In a study of 51 patients with Parkinson's disease, dystonia, and tremor, 54.9% were using advanced features of directional deep brain stimulation (DBS) after 15 months, indicating a significant uptake of these features among patients who were selected based on specific clinical characteristics.

Advanced DBS features were particularly beneficial for patients implanted in the Vim region, with 92% utilizing these features, compared to 44% in the STN and 40% in the GPi, suggesting that the choice of target may influence the need for advanced stimulation options.

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Temporal Stability of Lead Orientation in Directional Deep Brain Stimulation. [2021]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Pilot Study for Considering Subthalamic Nucleus Anatomy during Stimulation Using Directional Leads. [2020]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Long-Term Clinical Experience with Directional Deep Brain Stimulation Programming: A Retrospective Review. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

An Institutional Experience of Directional Deep Brain Stimulation and a Review of the Literature. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Real-Life Experience on Directional Deep Brain Stimulation in Patients with Advanced Parkinson's Disease. [2022]

6. Japan pubmed.ncbi.nlm.nih.gov

Surgical Strategy for Directional Deep Brain Stimulation. [2022]

7. England pubmed.ncbi.nlm.nih.gov

The actual use of directional steering and shorter pulse width in selected patients undergoing deep brain stimulation. [2022]