Personalized Brain Stimulation Targeting for Hard-to-Treat Depression
Tests personalized deep brain stimulation targets in adults with treatment-resistant depression.
Plain-language title generated from the registry record
Registry title: Personalized DBS Targeting for Treating Depression
Key facts
- Where
- Hangzhou, ChinaSee the site
- Phase
- Early phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06784388, who can take part
Where in China
- The Second Affiliated Hospital of Zhejiang University School of MedicineHangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Trial code
- NCT06784388
- Record updated
- 27 April 2026
- Original description
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:Read full original descriptionShow less
Clinical Application of Personalized DBS Target Optimization for Treating Depression
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?
Inclusion: A psychiatrist-confirmed diagnosis of major depressive disorder in accordance with the Diagnostic And Statistical Manual Of Mental Disorders.5th Ed (DSM-V); A psychiatric examination by two trained psychiatrists and a diagnosis consistent with the DSM-V; A history of depression of at least 12 months duration in depressed patients (including MECT) who have failed to respond to a full dose and course of treatment with 2 or more antidepressants of different mechanisms; A 17-item score on the HAMD scale ⩾ 20 at initial screening; A score of ≤ 50 on the Gross Assessment of Functioning (GAF) scale; The patient himself/herself or legal guardian was able to fully understand the therapy and agreed to enroll after signing an informed consent form.
Exclusion: Persons with a history of substance abuse within 12 months; persons with a previous history of epilepsy, and persons with febrile convulsions in childhood; Contraindications to DBS surgery and MRI; Persons with severe or unstable cardiac, hepatic, renal, endocrine, hematologic, and other medical disorders and co-morbidities with psychotic symptoms, including personality disorders diagnosed by history, questioning, and clinical examination; Persons with psychiatric disorders other than depression (except generalized anxiety); Patients with a history of suicide attempts within the past 6 months or more than 2 suicide attempts within the past 2 years; Women who are breastfeeding, pregnant, and patients who are pregnant or intend to become pregnant during the clinical study; Years of education less than or equal to 9 years; Patients who are involuntarily hospitalized.