DBS for Depression

Recruiting in Palo Alto (17 mi)

Overseen by Albert J Fenoy, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Northwell Health

Must not be taking: Anticoagulants

Disqualifiers: Psychosis, Substance abuse, Pregnancy, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial aims to test if deep brain stimulation can help people with treatment-resistant depression. The device is implanted in the brain and sends electrical signals to control mood. Researchers will monitor patients over several years to see if it reduces depression symptoms. Deep brain stimulation (DBS) has a decades-long history in psychiatric neurosurgery and has shown promise for treatment-resistant depression.

Will I have to stop taking my current medications?

The trial requires participants to be on a stable psychiatric medication regimen for at least 6 weeks before joining and to continue this regimen for the first 6 months. Changes to medications can be made during the study based on the clinical judgment of the study psychiatrist.

What data supports the effectiveness of this treatment for depression?

Directional deep brain stimulation (DBS) has been shown to improve clinical benefits by better directing electrical currents, which can enhance the therapeutic effect and reduce side effects. This has been observed in patients with movement disorders, suggesting potential benefits for other conditions like depression. ^{1 2 3 4 5}

Is Deep Brain Stimulation (DBS) safe for humans?

Research shows that while DBS can have side effects, using directional leads may help reduce these by allowing more precise control of the stimulation. However, adverse events can occur, especially during device replacements, so careful management is important. ^{1 2 5 6 7}

How is the Medtronic SenSight Directional DBS lead treatment different from other depression treatments?

The Medtronic SenSight Directional DBS lead is unique because it uses directional leads that allow for precise control of the stimulation field, which can reduce side effects and improve effectiveness compared to traditional DBS systems. This technology also requires less electrical power and can be adjusted more accurately to target specific brain areas, potentially offering better outcomes for patients with depression. ^{1 3 5 8 9}

Research Team

Albert J Fenoy, MD

Principal Investigator

Northwell Health

Eligibility Criteria

This trial is for adults aged 22-70 with severe, treatment-resistant depression. They must have tried multiple medications, psychotherapy, and possibly ECT without success. Participants need to be stable on their current meds and willing to be monitored over 5 years. Exclusions include those with psychosis history, unstable living situations, certain medical conditions or contraindications for surgery.

Inclusion Criteria

Your ability to function in daily life is very low, based on a special score called the Global Assessment of Function (GAF) score.

Patients with a history or diagnosis of generalized anxiety disorder (GAD) at the time of enrollment so long as Major Depressive Disorder (MDD) is the primary psychiatric diagnosis in the medical opinion of an investigator

At enrollment, provides the following information from at least two (2) verifiable contacts who reside within a 10-mile radius of the patient: name, relationship to patient, address (email mail); and telephone (mobile, home, work as applicable)

Exclusion Criteria

Within the past six months, you have been diagnosed with a substance abuse problem according to the guidelines used by doctors.

You have a condition that requires regular MRI scans.

I am currently taking medication to prevent blood clots.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Device Implantation

Participants are implanted with a deep brain stimulation device

1 week

1 visit (in-person)

Treatment

Participants undergo treatment with the DBS device, which is ON for 8.5 months and OFF for 3.5 months during the first year

12 months

Regular monitoring visits

Discontinuation Phase

Participants are randomized into two groups for crossover treatment analysis of different parameter settings

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 years

Treatment Details

Interventions

• Medtronic SenSight Directional DBS lead (Procedure)

Trial Overview Researchers are testing a Medtronic SenSight Directional DBS lead device implanted in participants to treat resistant depression. Over five years, the device's effectiveness will be assessed by turning it off at random times without participants' knowledge and comparing their questionnaire scores during these periods.

Participant Groups

Group I: Discontinuation Phase Group 2 Experimental Treatment 1 Intervention

Patients will be randomized into two groups for crossover treatment analysis of different parameter settings for six weeks.

Group II: Discontinuation Phase Group 1 Experimental Treatment 1 Intervention

Patients will be randomized into two groups for crossover treatment analysis of different parameter settings for six weeks.

Medtronic SenSight Directional DBS lead is already approved in Canada for the following indications:

Approved in Canada as Deep Brain Stimulation for:

• Parkinson’s disease
• Epilepsy
• Essential tremor
• Dystonia
• Obsessive-compulsive disorder

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Zucker Hillside Hospital Queens, NY

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Patients Recruited

470,000+

Medtronic

Industry Sponsor

Trials

627

Patients Recruited

767,000+

Findings from Research

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Directional DBS leads show large deviations from their intended implantation orientation. Dembek, TA., Hoevels, M., Hellerbach, A., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain impedance variation of directional leads implanted in subthalamic nuclei of Parkinsonian patients. Eleopra, R., Rinaldo, S., Devigili, G., et al.[2020]

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]

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

Deep Brain Stimulation: When to Test Directional? Debove, I., Petermann, K., Nowacki, A., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to avoid trivial mistakes during IPG replacement in patients treated with DBS for movement disorders: technical note from 13-years experience. Latini, F., Sensi, M., Preda, F., et al.[2015]

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

Intraoperative Local Field Potential Beta Power and Three-Dimensional Neuroimaging Mapping Predict Long-Term Clinical Response to Deep Brain Stimulation in Parkinson Disease: A Retrospective Study. di Biase, L., Piano, C., Bove, F., et al.[2023]

References

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

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

2. England pubmed.ncbi.nlm.nih.gov

Directional DBS leads show large deviations from their intended implantation orientation. [2020]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Brain impedance variation of directional leads implanted in subthalamic nuclei of Parkinsonian patients. [2020]

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

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

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

Deep Brain Stimulation: When to Test Directional? [2023]

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

How to avoid trivial mistakes during IPG replacement in patients treated with DBS for movement disorders: technical note from 13-years experience. [2015]

8. Japan pubmed.ncbi.nlm.nih.gov

Surgical Strategy for Directional Deep Brain Stimulation. [2022]

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

Intraoperative Local Field Potential Beta Power and Three-Dimensional Neuroimaging Mapping Predict Long-Term Clinical Response to Deep Brain Stimulation in Parkinson Disease: A Retrospective Study. [2023]