RecruitingPhase 1NCT06096207

DBS for Depression

Deep Brain Stimulation (DBS) Therapy for Treatment Resistant Depression


Sponsor

Northwell Health

Enrollment

20 participants

Start Date

Oct 18, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to demonstrate the feasibility and safety of deep brain stimulation in treatment resistant depression. The main questions it aims to answer are: * Is deep brain stimulation effective in treating treatment resistant depression? * Does deep brain stimulation improve overall clinical well-being and functioning? Participants will be implanted with a deep brain stimulation device. They will then be monitored over a 5-year period by using multiple questionnaires to track their depression symptoms. The device will be turned off at certain time points, unbeknown to the participant, to show the efficacy of the device when it is turned on. The device will be ON for 8.5 months and OFF for 3.5 months during the first year. Researchers will compare questionnaire scores when the device is off versus on to see if the device is working in reducing depression.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing deep brain stimulation (DBS) — a surgical procedure that implants small electrodes in the brain to deliver electrical pulses — as a treatment for severe, treatment-resistant depression or bipolar disorder. It is intended for people whose depression has not improved with many years of medications, therapy, or other treatments. **You may be eligible if...** - You are between 18 and 65 years old - You have a diagnosis of major depressive disorder or bipolar disorder (I or II) - Your depression is severe and has lasted at least 5 years since the first episode, with at least 4 episodes or a chronic course - You score at least 21 on standardized depression rating scales - You have significant disability in daily functioning - You have tried multiple treatments without adequate relief **You may NOT be eligible if...** - You are unable to give informed consent - You have medical conditions making brain surgery too risky - You have active suicidal plans requiring immediate intervention - You have substance use disorders or other conditions incompatible with the procedure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMedtronic SenSight Directional DBS lead

At the ninth month post DBS implantation, the participant will enter a discontinuation phase of a duration of 6 weeks. The device will be turned on and off without participants' knowledge. After 6 weeks, the device will be turned back on if it was off. Whether the stimulation is active or not, it will be double blinded.


Locations(1)

Zucker Hillside Hospital

Queens, New York, United States

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NCT06096207


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