Non-invasive brain-computer interface for people with depression

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

This study is testing a new brain-computer interface to see if it can help understand depression better by looking at brain and blood changes in people with Major Depressive Disorder.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 12 Years and up
• Sex: All
• Sponsor: Shanghai Mental Health Center (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06417437 on ClinicalTrials.gov

What this trial studies

This study focuses on developing a brain-computer interface (BCI) system to identify neurobiological markers associated with Major Depressive Disorder (MDD). It aims to validate this application by assessing various biological indicators and cognitive states in patients diagnosed with MDD. Participants will undergo comprehensive evaluations, including blood tests and brain imaging, to compare their results with healthy individuals. The study seeks to enhance the understanding of depression and improve treatment methodologies through innovative technology.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 12 and older who meet the DSM-5 criteria for depression and have a significant level of depressive symptoms.

Not a fit: Patients with severe physical illnesses, organic brain diseases, or those with a history of substance abuse may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more accurate diagnoses and personalized treatment options for patients with depression.

How similar studies have performed: While the use of neurobiological markers in depression is an emerging field, similar studies have shown promise in utilizing technology for mental health assessment, though this specific approach may be novel.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Mental Health Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Zhenghui Yi, chief physician

Conditions Depression; Major Depressive Disorder; Bipolar Depression