Probing Prefrontal Cortex Hemodynamic Alterations for Major Depression Disorder (MDD)
11 de julio de 2018 actualizado por: Xijing Hospital
Probing Prefrontal Cortex Hemodynamic Alterations During Facial Emotion Recognition for Major Depression Disorder Through Functional Near-infrared Spectroscopy
Major depression disorder (MDD) has high estimated lifetime prevalence rates of 16.6%.
Currently, the diagnosis for the MDD mainly depends on patients' reports of symptoms, observed behaviors and disease course.
Establishment of clinically useful biomarkers for the MDD diagnosis would enhance patient management and treatment effect, and lead to the therapies adjusted to the individual.
However, no such biomarkers have been established up to now.
Therefore, the development of objective and feasible biomarkers is of special significance and a great challenge for accurate and early diagnosis and treatment of depression, in order to overcome the limitations of relying on clinical interviews alone.The ability to correctly recognize emotional states from faces is instrumental for interpersonal engagement and social functioning.
Impairments processing of facial emotional expressions and biased facial emotion detection are frequently found in the MDD patients.
To date, the studies on neural mechanism of the facial emotion recognition of the MDD patients were mainly based on the functional magnetic resonance imaging (fMRI).
Functional near-infrared spectroscopy (fNIRS) has not been applied for the facial emotion recognition for the depression patients up to now.
To bridge the important gap in the literature, we used the fNIRS methodology to investigate the neural mechanisms of facial emotion recognition for the patients with depression.
We hypothesize the physiological feature of the hemodynamic responses in prefrontal cortex measured by fNIRS under the task of face emotion recognition, including the difference of the median, the Mayer wave power, the mean cross wavelet coefficient, and the mean wavelet coherence coefficient, combined with the behavior measurement (behavior accuracy and response time), could provide a reliable and feasible diagnosis approach to differentiate patients with the MDD from healthy control (HC) subjects with acceptable sensitivity and specificity.
Descripción general del estudio
Estado
Desconocido
Condiciones
Descripción detallada
The fMRI technique for functional imaging were limited by the fact that the individuals need to be placed in an uncomfortable or unnatural setting and foreign, noisy, dark, or claustrophobic environment (e.g., lying in a supine position in a narrow gantry with the head restrained during the entire examination), for accurate measurement during the procedure, with relatively lower temporal resolution.
In contrast, a multi-channel fNIRS machine provides a completely non-invasive, quiet and mobile measurement of brain function in ordinary clinical settings and allows patients to be comfortably seated in a normal posture in a well-lit room, with higher temporal resolution making it possible to obtain a recording of the actual time course of a hemodynamic epoch in response to a specific cognitive task (e.g., facial emotion recognition task in our study) in a single trial.
Additionally, due to the small operating and maintenance costs associated with NIRS, it is possible to run fNIRS study with a large sample of participants.
Tipo de estudio
De observación
Inscripción (Anticipado)
200
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Shaanxi
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Xi'an, Shaanxi, Porcelana, 710032
- Department of psychiatry, Xijing Hospital; Research Institute of Biomedical Engineering, Xi'an Jiaotong University
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 35 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
This study was performed in Xijing Hospital and Xi'an Jiaotong University in China.
100 right-handed subjects meeting DSM-IV criteria for major depression were recruited by advertisement to participate in the study, and were matched with a control group of 100 comparison subjects of university staff members, university students and members of the general population.
Descripción
Inclusion Criteria:
- MDD group:
All subjects were free of psychotropic medication for a minimum of 4 weeks; Psychiatric diagnosis was determined by DSM-IV criteria; Depressed subjects were included with 17-item Hamilton Rating Scale for Depression (HRSD) scores ≥ 18; Mini-mental State Examination(MMSE) ≥ 24; All subjects had normal or corrected-to-normal vision.
- HC group:
All subjects were free of psychotropic medication for a minimum of 4 weeks; All subjects did not have any mental, neurological or physical diseases；HRSD scores ≤ 7; MMSE ≥ 28; All subjects had normal or corrected-to-normal vision.
Exclusion Criteria:
- Exclusion criteria were any history of neurologic trauma resulting in loss of consciousness, any current neurologic disorder, any lifetime psychiatric disorder other than major depression in the MDD subjects, or any lifetime psychiatric disorder in control subjects. Careful attention was paid to excluding substance abuse disorders.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Control de caso
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
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MDD group
The major depression group (MDD group) received antidepressant treatment but did not interfere with drug selection.
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HC group
The healthy control group (HC group) don't accept intervention and treatment.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Hamilton Depression Scale-17(HAMD-17) score alterations
Periodo de tiempo: Change from baseline HAMD-17 scores at 6 months
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The HAMD-17 scores are to evaluate the severity degree of depression, and the HAMD-17 scores reduction rate is used to evaluate the clinical treatment effect.
If the reduction rate exceeds 50%, it indicates that the clinical treatment is effective.
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Change from baseline HAMD-17 scores at 6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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facial emotion recognition
Periodo de tiempo: Difference at facial emotion recognition between day 1 and month 6.
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The ability to correctly recognize emotional states from faces is instrumental for interpersonal engagement and social functioning.
Impairments processing of facial emotional expressions and biased facial emotion detection are frequently found in the MDD patients.
Functional near-infrared spectroscopy (fNIRS) has not been applied for the facial emotion recognition for the depression patients up to now.
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Difference at facial emotion recognition between day 1 and month 6.
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Pittsburgh Sleep Quality Index（PSQI）
Periodo de tiempo: Difference at PSQI between day 1, month 3 and month 6.
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PSQI was used to assess the quality of sleep for subjects in the recent month.
The total score ranges from 0 to 21 points.
The higher the score, the worse the sleep quality.
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Difference at PSQI between day 1, month 3 and month 6.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Huaning Wang, doctorate, Department of Psychiatry, Xijing Hospital
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Zwick JC, Wolkenstein L. Facial emotion recognition, theory of mind and the role of facial mimicry in depression. J Affect Disord. 2017 Mar 1;210:90-99. doi: 10.1016/j.jad.2016.12.022. Epub 2016 Dec 19.
- Tsuchida A, Fellows LK. Are you upset? Distinct roles for orbitofrontal and lateral prefrontal cortex in detecting and distinguishing facial expressions of emotion. Cereb Cortex. 2012 Dec;22(12):2904-12. doi: 10.1093/cercor/bhr370. Epub 2012 Jan 5.
- Takizawa R, Fukuda M, Kawasaki S, Kasai K, Mimura M, Pu S, Noda T, Niwa S, Okazaki Y; Joint Project for Psychiatric Application of Near-Infrared Spectroscopy (JPSY-NIRS) Group. Neuroimaging-aided differential diagnosis of the depressive state. Neuroimage. 2014 Jan 15;85 Pt 1:498-507. doi: 10.1016/j.neuroimage.2013.05.126. Epub 2013 Jun 10. Erratum In: Neuroimage. 2015 Apr 1;109:530.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
16 de febrero de 2017
Finalización primaria (Anticipado)
31 de agosto de 2018
Finalización del estudio (Anticipado)
31 de diciembre de 2018
Fechas de registro del estudio
Enviado por primera vez
24 de junio de 2018
Primero enviado que cumplió con los criterios de control de calidad
11 de julio de 2018
Publicado por primera vez (Actual)
23 de julio de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
23 de julio de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
11 de julio de 2018
Última verificación
1 de febrero de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KY20172012-1
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Indeciso
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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