Actively Recruiting

Phase 4
Age: 12Years +
All Genders
Healthy Volunteers
NCT06417437

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

Age: 12Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China, 200030

Actively Recruiting

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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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