NCT06417437RecruitingPhase 4
Non-invasive BCI and Application Verification for Depressed People
New Non-invasive Brain-computer Interface: Theory, Technology and Application Demonstration - Studies on and Intervention for Depressed People Based on Non-invasive BCI and Application Verification
Source: ClinicalTrials.gov · Last updated 16 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 23 Apr 2024
- Start date
- 1 Jul 2023
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Shanghai Mental Health Center
- Diseases
- Depression, Bipolar disorder
- NCT number
- NCT06417437
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 400
- From 1 Jul 2023 to the primary completion date, 31 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant or previous history of organic brain disease or severe traumatic brain injury, personal or family history of epilepsy;
- 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;
Other illness
- 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;
- Obvious visual and auditory impairment, unable to cooperate in completing neuropsychological and scale assessments.
Other
- Pregnancy or lactation period;
Who the study is looking for
- ≥ 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
Age in the registry: 12 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Mental Health Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
Related publications
- Effect of iTBS on suicidal ideation and emotion regulation in major depressive disorder: a randomized clinical trial.BMC Psychiatry · 2026 · PMID 42286600
This page is information, not medical advice. Discuss any trial with your doctor.