No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
12 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
400 (estimated)
Sponsor
Shanghai Mental Health Center · Other
Who this trial is looking for
This trial is looking for people aged 12 and older who have been diagnosed with depression. Participants will help test new brain stimulation systems designed to improve emotional health.
Are You a Good Fit for This Trial?
You may be able to join if
I am 12 years old or older.
I have been diagnosed with depression.
I can understand the research content and want to participate.
I have a primary school education or above.
You may not be able to join if
I have a serious brain injury or brain disease.
I have severe heart, liver, or kidney problems.
I am pregnant or breastfeeding.
I have a history of substance abuse.
I have had certain physical therapies in the last six months.
I have implanted electronic devices like a pacemaker.
I have significant visual or hearing impairments.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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.
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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 participa…
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.
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