Actively Recruiting
Non-invasive BCI and Application Verification for Depressed People
Led by Shanghai Mental Health Center · Updated on 2024-05-16
400
Participants Needed
1
Research Sites
213 weeks
Total Duration
On this page
Sponsors
S
Shanghai Mental Health Center
Lead Sponsor
T
The Fourth People's Hospital of Chengdu
Collaborating Sponsor
AI-Summary
What this Trial Is About
Major Depressive Disorder (MDD) is a serious mental illness and public health problem that poses threat to both physical and mental health. According to statistics from WHO, it is estimated that more than 350 million people worldwide suffer from depression, with a prevalence rate of 2.1% in China, which is approximately 30 million people. At present, due to the lack of neurobiological markers for screening and diagnosing depression, the identification and diagnosis of MDD are based on the judgment of professional doctors, and the treatment mostly relies on clinical symptoms. In terms of treatment, medication remains the main stream for MDD. Although current methods have certain therapeutic effects, patients still suffer from various side effects and poor cognitive function.In current clinical practice, relying purely on symptomatic diagnosis and treatment is difficult to meet the needs of clinical practice, so there is an urgent need to search for neurobiological markers in depression and develop targeted non-invasive intervention technologies. This study aims to combine advanced brain imaging technology, digital twin-brain models, multi-source information decoding technology, integrated detection and intervention technology. The target is to create two new types of non-invasive BCI systems that can regulate emotions. One is a intervention BCI system for MDD that is suitable for hospital settings with the purpose of precise physical stimulation, and the other one is an ecological BCI system that regulate emotions and intervene with depression which is suitable for both hospital settings and future family environments. This study will collect a comprehensive collection of physiological and biochemical indicators from patients with depression and from healthy control groups, as well as multimodal information such as head surface electroencephalography, MRI, and eye movements under different brain states, to personalize the available BCI information of depression related brain regions, circuits, and networks. The study also tries to explore emotional-interactive games that can intervene with depression and build a game data base that is dedicated to MDD. Other goals include designing and establishing two new types of emotional regulation systems, which are precise external physical stimulation intervention and ecological intervention, constructing a BCI regulation system, and conducting application verification to evaluate the regulation effect.
CONDITIONS
Official Title
Non-invasive BCI and Application Verification for Depressed People
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 12 years old, male or female, right-handed, Han ethnicity
- Diagnosed with depression according to DSM-5, with HAMD-17 score above 17 and YMRS score below 6
- At least primary school education, able to understand the study and willing to participate with signed consent
You will not qualify if you...
- History of organic brain disease, severe traumatic brain injury, or epilepsy in self or family
- Severe heart, liver, or kidney dysfunction
- Severe physical illness
- History of substance dependence or abuse
- Mental disorders caused by organic diseases or substance use
- Pregnant or lactating women
- Physical therapy like MECT or TMS within past 6 months
- Implant of vegetative nerve stimulators
- Presence of electronic or metal implants such as pacemakers or shunts
- Significant visual or hearing impairment preventing cooperation with assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
Research Team
Z
Zhenghui Yi, chief physician
CONTACT
Q
Qinyu Lv, chief physician
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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