RecruitingEarly Phase 1NCT06784388

Personalized DBS Targeting for Treating Depression

Clinical Application of Personalized DBS Target Optimization for Treating Depression

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

5 participants

Start Date

Jan 5, 2025

Study Type

INTERVENTIONAL

Conditions

Treatment Resistant Depression (TRD)

Summary

The goal of this clinical trial is to optimize the target brain areas for deep brain stimulation (DBS) for depression based on personalized brain imaging and stereo-electroencephalography（SEEG), to administer long-term DBS treatment in the target brain areas, to assess the effectiveness and safety of DBS for refractory depression and to validate the method of personalized optimization of DBS targets. The main questions it aims to answer are: 1. Where is the optimal DBS target brain region for each patient? 2. What are the optimal DBS parameters for each patient ? 3. What are the neural biomarkers of depression symptoms for each patient? 4. Are the optimized DBS strategies effective in treating refractory depression?

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing personalized deep brain stimulation (DBS) — a procedure where electrodes are implanted in the brain to send electrical signals — for people with severe, treatment-resistant depression. The "personalized" part means targeting stimulation to the specific brain area most likely to help each individual patient. **You may be eligible if...** - You have been diagnosed with major depressive disorder (MDD) by a psychiatrist - You have had depression for at least 12 months - You have tried at least 2 different antidepressants at full doses without improvement - Your depression diagnosis has been confirmed by two trained psychiatrists **You may NOT be eligible if...** - You have not tried adequate medication treatments - You have conditions that make brain surgery too risky - Your depression was first diagnosed after age 55 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

DEVICEDeep Brain Stimulation(DBS)

During the DBS treatment phase, the DBS device will apply electrical stimulation to the patient's target brain regions using a specific strategy, and if the efficacy of this phase is not satisfactory, electrical stimulation will continue to be applied during the efficacy observation phase after DBS shutdown.

DRUGEsketamine

SEEG intraoperative experiment: patients will be implanted with microelectrodes and connected to an electrophysiological recorder under local anesthesia. Intraoperative neurophysiological baseline will be recorded for 5 minutes, and esketamine will be injected intravenously at a dose of 0.5 mg/kg, and neurophysiological recordings will be continued for 15 minutes to observe the neuronal electrophysiological changes in various brain regions and target points.