Non-invasive BCI and Application Verification for Depressed People

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age12+
SponsorShanghai Mental Health Center

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

≥ 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

Disqualifiers

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.);

Trial design

Design model

Parallel

Treatments tested in this trial

  • SSRI

    Drug

    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.

  • rTMS

    Device

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

  • Neuro-Feedback

    Behavioral

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

  • Game Regulation

    Behavioral

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

Treatment groups

400 Participants
are divided into 5 treatment groups
Group A: Medication GroupActive comparator 1 intervention
Group B: Traditional rTMs GroupExperimental treatment 2 interventions
Group C: New rTMS GroupExperimental treatment 2 interventions
Group D: Neuro-Feedback GroupExperimental treatment 2 interventions
Group E: Game-regulation GroupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

EEG power in alpha band between the depression patient group and healthy controls.

Changes from baseline in multimodal emotional data as assessed by EEG at 2 weeks.

Time frame
2 weeks
2

EEG power in beta band between the depression patient group and healthy controls.

Changes from baseline in multimodal emotional data as assessed by EEG at 2 weeks.

Time frame
2 weeks
3

MRI imaging of DLPFC between the depression patient group and healthy controls.

Changes in brain imaging from baseline in multimodal emotional data as assessed by MRI at 2 weeks.

Time frame
2 weeks
4

HbO in fNIRS between the depression patient group and healthy controls.

Changes from baseline in multimodal emotional data as assessed by fNIRS at 2 weeks.

Time frame
2 weeks

Secondary outcomes

1

The change in the state of depression in depression patient groups

The state of depression in patient group measured by SDS(0-80) at 2 weeks.

Time frame
2 weeks
2

The change in the state of agitation in depression patient groups

The state of depression in patient group measured by HCL-32(0-32) at 2 weeks.

Time frame
2 weeks
3

The change in the state of depression in depression patient groups

The state of depression in patient group measured by SDS(0-80) at 4 weeks.

Time frame
4 weeks
4

The change in the state of agitation in depression patient groups

The state of depression in patient group measured by HCL-32(0-32) at 4 weeks.

Time frame
4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Mental Health Center

Lead sponsor

The Fourth People's Hospital of Chengdu

Collaborator

Shanghai Jiao Tong University School of Medicine

Collaborator

University of Electronic Science and Technology of China

Collaborator

East China Normal University

Collaborator