RecruitingPhase 4NCT06417437

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


Sponsor

Shanghai Mental Health Center

Enrollment

400 participants

Start Date

Jul 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a non-invasive brain-computer interface (BCI) — a device that reads brain signals — to help diagnose and monitor depression. Researchers want to verify how well this technology can detect brain patterns associated with depression and potentially support treatment. **You may be eligible if...** - You are 12 or older, right-handed, and of Han Chinese ethnicity - You have been diagnosed with depression according to standard diagnostic criteria (DSM-5) - Your depression score (HAMD-17) is above 17 and your mania score (YMRS) is below 6 - You have completed at least primary school education - You are willing to participate and sign consent **You may NOT be eligible if...** - You have a history of brain disease or severe traumatic brain injury, or epilepsy - You have serious heart, liver, or kidney problems - You have any implanted electronic or metal devices (e.g., pacemakers, stents, orthopedic plates) - You are pregnant or breastfeeding - You have received electroconvulsive therapy (ECT) or TMS brain stimulation in the past 6 months - You have substance use disorder - You have significant vision or hearing impairment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSSRI

Patients are not masked from the types of intervention they receive. Assessment will be done before and after each intervention. Each group is independent from other groups.

DEVICErTMS

Patients will be treated targeting either the traditional brain region or new region.

BEHAVIORALNeuro-Feedback

Patients under 18 years old will first be considered this treatment before other methods.

BEHAVIORALGame Regulation

Patients will learn how to play several games that can supposedly regulate or affect negative emotions.


Locations(1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

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NCT06417437


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