NCT06417437 Non-invasive BCI and Application Verification for Depressed People
| NCT ID | NCT06417437 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Shanghai Mental Health Center |
| Condition | Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2023-07-01 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 400 participants in total. It began in 2023-07-01 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * ≥ 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 Exclusion Criteria: * 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.
Contact & Investigator
Zhenghui Yi, chief physician
STUDY CHAIR
Shanghai Mental Health Center
Frequently Asked Questions
Who can join the NCT06417437 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06417437 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06417437 currently recruiting?
Yes, NCT06417437 is actively recruiting participants. Contact the research team at yizhenghui1971@163.com for enrollment information.
Where is the NCT06417437 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06417437 clinical trial?
NCT06417437 is sponsored by Shanghai Mental Health Center. The principal investigator is Zhenghui Yi, chief physician at Shanghai Mental Health Center. The trial plans to enroll 400 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.