Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06417437
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-04-23
Brief Title:
Non-invasive BCI and Application Verification for Depressed People
Sponsor:
Shanghai Mental Health Center
Organization:
Shanghai Mental Health Center
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 21 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 functionIn 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
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 functionIn 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
Detailed Description:
This study aims to establish a BCI regulation scheme and system for individuals with mdd and to conduct validation for this application Four more detailed contents are being designed including 1 providing biological markers in brain regions circuits and networks that are probably related to MDD 2 assessment models of the state of brain and multivariate signal mapping models 3 virtual regulation paradigms evaluations on the effect of the regulation and 4 multimodal information collection and regulation software and hardware technologies
Shanghai Mental Health Center as the sponsor institution tends to recruit MDD patients from daily outpatient service The paticipants personal information will be noted and then the patients will undergo different assessment on their level of depression anxiety anhedonia manic state cognitive status effect and side effects of the current treatment and their biological rhythm sleep quality of life etc Peripheral blood will be drawn for different potential biomarkers as well as multimodal information such as EEG eye movement magnetic resonance imaging magnetoencephalogram fNIRS and etc Then compare the following laboratory indicators between depressed patients and healthy individuals such as differences in the concentration and gene expression of peripheral blood inflammatory factors oxidative stress indicators brain-derived neurotrophic factors brain imaging electrophysiology blood oxygen and etc The work above is to obtain specific neurobiological markers of MDD
Intervention measures are as follows
1 Traditional medication with SSRIs MDD patients will be give different SSRIs medication and undergo a two-week treatment after which the above assessments will be done again to evaluation the efficacy and side effects of the current treatment For MDD patients with anhedonia other medication can be considered such as Voxetine and Bupropion
2 rTMS combined with traditional SSRIs medication The current brain regions chosen for rTMS include dorsolateral pre-frontal cortex In this part the study tends to find out new potential brain regions suitable for physical treatment in MDD patients The considered brain regions include orbitofrontal cortex cerebellum and others It uses a classic 8-shaped coils butterfly coils deep coils etc neural navigation to locate stimulation targets
3 Treatment based on neurobiological feedback In this kind of treatment MDD patients are treated with neurobiological feedback and will be monitored by EGG to catch unique and specific brain waves that may considered only found in MDD patients This treatment involves using different psychological paradigms including classic cognitive research paradigms to evaluate the outcome of neuron-training and cognitive function after treatment
Other technologies used in this study includes
1 Functional Magnetic Resonance Imaging Brain images will be captures during different functional tasks such as emotional matching Monetary Incentive Delay Task MID These images will be further analyzed to figure out the neuro-mechanism of MDD We will be using 3T Siemens PRISMA collecting data of rs-fMRIDTIT1T2 and fMRI
2 Electroencephalography In this part the investigators will be using the DSI-24 wireless dry electrode EEG system Each subject will undergo EEG collection experiments at least collecting EEG data in a resting state with eyes closed and open
3 Eye movement detection Eye movement will be traced using Tobii Pro Spectrum
4 Functional Near-Infrared Spectroscopy Patients will perform different tasks under the monitoring of a portable fNIRS device called Nirsport2 wireless wearable NIRS imaging system It consists of a 8-channel LED illuminator and 8-channel active sensor for fiberless optical detection During the tasks the device will provide the value and changes in the level of oxyhemoglobin and deoxygenated hemoglobin observed in the subjects
5 Magnetoencephalogram MEG is a completely non-invasive function detection technique widely used in the development and research of brain function and the clinical diagnosis of brain diseases MEG uses a sensitive magnetic sensor SQUID Superconducting Quantum Interferometer which is placed around the head to measure the abnormally weak magnetic field generated by neuronal activity The detected magnetic signal data will then be analyzed and processed by a computer and superimposed on magnetic resonance imaging MRI Through software 3D imaging the results can be more intuitive making the MEG have extremely high temporal and spatial resolution
MDD patients will be divided into different treatment gourds based on theirs condition and whether the chosen treatment would be the most suitable for them All individuals will undergo the above assessments to establish a comprehensive multimodal information data base and finally after comparing the outcome before and after the treatment the study tries to find out new and effective measures and validate their feasibility
Shanghai Mental Health Center as the sponsor institution tends to recruit MDD patients from daily outpatient service The paticipants personal information will be noted and then the patients will undergo different assessment on their level of depression anxiety anhedonia manic state cognitive status effect and side effects of the current treatment and their biological rhythm sleep quality of life etc Peripheral blood will be drawn for different potential biomarkers as well as multimodal information such as EEG eye movement magnetic resonance imaging magnetoencephalogram fNIRS and etc Then compare the following laboratory indicators between depressed patients and healthy individuals such as differences in the concentration and gene expression of peripheral blood inflammatory factors oxidative stress indicators brain-derived neurotrophic factors brain imaging electrophysiology blood oxygen and etc The work above is to obtain specific neurobiological markers of MDD
Intervention measures are as follows
1 Traditional medication with SSRIs MDD patients will be give different SSRIs medication and undergo a two-week treatment after which the above assessments will be done again to evaluation the efficacy and side effects of the current treatment For MDD patients with anhedonia other medication can be considered such as Voxetine and Bupropion
2 rTMS combined with traditional SSRIs medication The current brain regions chosen for rTMS include dorsolateral pre-frontal cortex In this part the study tends to find out new potential brain regions suitable for physical treatment in MDD patients The considered brain regions include orbitofrontal cortex cerebellum and others It uses a classic 8-shaped coils butterfly coils deep coils etc neural navigation to locate stimulation targets
3 Treatment based on neurobiological feedback In this kind of treatment MDD patients are treated with neurobiological feedback and will be monitored by EGG to catch unique and specific brain waves that may considered only found in MDD patients This treatment involves using different psychological paradigms including classic cognitive research paradigms to evaluate the outcome of neuron-training and cognitive function after treatment
Other technologies used in this study includes
1 Functional Magnetic Resonance Imaging Brain images will be captures during different functional tasks such as emotional matching Monetary Incentive Delay Task MID These images will be further analyzed to figure out the neuro-mechanism of MDD We will be using 3T Siemens PRISMA collecting data of rs-fMRIDTIT1T2 and fMRI
2 Electroencephalography In this part the investigators will be using the DSI-24 wireless dry electrode EEG system Each subject will undergo EEG collection experiments at least collecting EEG data in a resting state with eyes closed and open
3 Eye movement detection Eye movement will be traced using Tobii Pro Spectrum
4 Functional Near-Infrared Spectroscopy Patients will perform different tasks under the monitoring of a portable fNIRS device called Nirsport2 wireless wearable NIRS imaging system It consists of a 8-channel LED illuminator and 8-channel active sensor for fiberless optical detection During the tasks the device will provide the value and changes in the level of oxyhemoglobin and deoxygenated hemoglobin observed in the subjects
5 Magnetoencephalogram MEG is a completely non-invasive function detection technique widely used in the development and research of brain function and the clinical diagnosis of brain diseases MEG uses a sensitive magnetic sensor SQUID Superconducting Quantum Interferometer which is placed around the head to measure the abnormally weak magnetic field generated by neuronal activity The detected magnetic signal data will then be analyzed and processed by a computer and superimposed on magnetic resonance imaging MRI Through software 3D imaging the results can be more intuitive making the MEG have extremely high temporal and spatial resolution
MDD patients will be divided into different treatment gourds based on theirs condition and whether the chosen treatment would be the most suitable for them All individuals will undergo the above assessments to establish a comprehensive multimodal information data base and finally after comparing the outcome before and after the treatment the study tries to find out new and effective measures and validate their feasibility
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None