Closed-loop neuromodulation in an individual with treatment-resistant depression.
Katherine W Scangos, Ankit N Khambhati, Patrick M Daly...
https://pubmed.ncbi.nlm.nih.gov/34608328Actively Recruiting
Early Phase 1
Age: 18Years - 70Years
All Genders
ID06784388
Clinical Application of Personalized Deep Brain Stimulation Target Optimization for Treating Depression
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-04-27
5
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying personalized deep brain stimulation (DBS) to treat treatment-resistant depression by identifying the best brain targets using brain imaging and stereo-electroencephalography (SEEG). The trial aims to find the optimal brain region and stimulation settings for each patient, understand neural markers of depression, and assess the safety and effectiveness of this personalized approach. This early-phase study is sponsored by the Second Affiliated Hospital, School of Medicine, Zhejiang University. The study has four phases. First, a 7-day preoperative phase includes symptom assessments and brain imaging. Next, during a 14-day SEEG phase, electrodes will be implanted to record brain activity. Then, the 421-day DBS treatment phase involves implanting a DBS device to provide electrical stimulation while patients complete depression assessments and follow-up visits every two weeks. Finally, a 2-month observation phase without stimulation will assess maintained effects; if symptoms return, DBS will restart until study completion. Participants will undergo regular evaluations including depression rating scales such as the Hamilton Rating Scale for Depression (HAMD), Montgomery-Asberg Depression Rating Scale (MADRS), and others every two weeks during treatment and observation. Safety and adverse events will be monitored perioperatively and throughout the study. The trial will measure changes in depression scores from before treatment through the entire study period, lasting over 15 months.
CONDITIONS
Brief Title
Personalized DBS Targeting for Treating Depression
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosis of major depressive disorder confirmed by two psychiatrists using DSM-V criteria
- History of depression lasting at least 12 months and failure to respond to two or more antidepressants
- A 17-item Hamilton Rating Scale for Depression (HAMD) score of 20 or higher at screening
- Gross Assessment of Functioning (GAF) score of 50 or less
- Ability to understand and provide informed consent
You will not qualify if you...
- Severe or unstable medical disorders including cardiac, hepatic, renal, endocrine, or hematologic conditions
- Psychiatric disorders other than depression, except generalized anxiety
- History of substance abuse within the past 12 months
- History of epilepsy or febrile convulsions in childhood
- Suicide attempts within the past 6 months or more than two attempts in the past 2 years
- Women who are pregnant, breastfeeding, or planning pregnancy during the study
- Contraindications to DBS surgery or MRI
- Education level of 9 years or less
- Involuntary hospitalization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Preoperative Assessment
Duration - 7 days
Participants complete preoperative symptom assessments, brain imaging, and task-state functional magnetic resonance imaging (fMRI) assessments.
Visits as needed during the 7-day period
SEEG Assessment
Duration - 14 days
Participants are implanted with SEEG electrodes and complete a series of SEEG assessments, including intraoperative neurophysiological recordings and esketamine administration.
Visits throughout the 14-day period
DBS Treatment
Duration - 421 days
Participants receive deep brain stimulation treatment with implanted DBS devices and complete depressive symptom assessments along with follow-up visits.
Follow-up visits every 2 weeks during treatment
Efficacy Observation after DBS Shutdown
Duration - 2 months
Participants with good outcomes after DBS treatment have the electrical stimulation shut down for observation of treatment efficacy maintenance, with symptom assessments and follow-up visits. If symptoms rebound, DBS treatment may restart during this period.
Follow-up visits every 2 weeks during observation
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
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Research Team
J
Junming Zhu, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Cingulate dynamics track depression recovery with deep brain stimulation.
Sankaraleengam Alagapan, Ki Sueng Choi, Stephen Heisig...
https://pubmed.ncbi.nlm.nih.gov/37730990