Non-invasive BCI and Application Verification for Depressed People

Recruiting now · Phase 4

Conditions studied: Depression, Major Depressive Disorder, Bipolar Depression

In brief

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.

Key facts

Study ID: NCT06417437
Run by: Shanghai Mental Health Center
People needed: 400
Starts: 2023-07-01
Expected to finish: 2027-07-31
Last updated by the study team: 2024-05-16

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

≥ 12 years old, male or female, right-handed, Han ethnicity
Meets the DSM-5 diagnostic criteria for depression, with HAMD-17 scores greater than 17 and YMRS scores less than 6;
Primary school education or above, able to understand the research content, willing to participate in this study and sign an informed consent form

You may not qualify if…

Concomitant or previous history of organic brain disease or severe traumatic brain injury, personal or family history of epilepsy;
Severe abnormalities in heart, liver, and kidney function;
Patients with severe physical illnesses;
History of substance dependence or abuse (alcohol, cocaine, drugs, etc.);
Patients with mental disorders caused by organic diseases, drug or alcohol induced mental disorders, and other mental disorders;
Pregnancy or lactation period;
Within six months, physical therapy such as MECT and TMS should be used;
Implants of vegetative nerve stimulation;
Individuals who have implanted electronic or metal instruments (such as pacemakers, defibrillators, stents, orthopedic plates, etc.) and undergo ventriculoperitoneal shunt surgery;
Obvious visual and auditory impairment, unable to cooperate in completing neuropsychological and scale assessments.

Where it is running

Shanghai Mental Health Center — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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