Clinical Testing of Near Infrared Spectroscopy (NIRS) for Quantitative Assessment of Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in Frontal Oxyhemoglobin concentration 3 weeks after initiation of treatment for MDD
研究概览
简要总结
Develop a NIRSIT testing protocol that can be administered in the diagnostic setting and reliably distinguishes the symptoms and severity of depression, with the help of repeated measure (up to five visits per subject) comparison of patients being treated for Major Depressive Disorder with control, non-depressed subjects.
详细描述
Background & Significance:
The history of utilizing the near infrared (NIR) spectrum (650-1000nm) in cognitive studies is chronicled in a recent review. Taking advantage of the facts that human tissue is relatively transparent to NIR and hemoglobin absorbs those wavelengths of light, in 1977, Jobsis developed a non-invasive device able to detect oxygenation changes in the brain. He later used this technique to study cerebral oxygenation in new born infants. The first publications describing NIRS results began to appear in the early 1990s, and in 2000, the first commercially available device was marketed. In 2009, Hitachi released the first battery operated wireless/ wearable device. In the 3 years preceding this 2012 review, ~400 articles utilizing this technology have been published in the fields of neurology (Alzheimer's disease, dementia, depression, epilepsy, Parkinson's, rehabilitation, stroke), psychiatry (anxiety, substance abuse, schizophrenia), education (attention, comprehension, reasoning) and basic research (pain, sleep).
Device:
Near Infrared Spectroscopy (NIRS) provides a non-invasive measurement of frontal lobe blood flow and saturation over time. The NIRSIT device has ninety-six (96) two color infrared lasers and paired photodiodes which record oxygen saturation to a depth of 2 cm from the frontal cortex of humans. NIRSIT provides a measurement of blood saturation from over 200 prefrontal regions providing high spatial resolution at a scan rate of 32 Hz providing high temporal resolution. NIRSIT can provide real-time cognitive studies which can discriminate cognitive workload, concentration, and emotional stress and anxiety. NIRS provides 200 measurements of oxy, deoxy, total hemoglobin, and heart rate 32 times per second.
Non-Significant Risk Justification:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subjects who sign informed consent.
- •Controls: Volunteers over 18 years of age who are not depressed.
- •Patients over 18 years of age with a diagnosis of Major Depressive Disorder, receiving clinical therapy at SFVAMC.
排除标准
- •Subjects who cannot sign informed consent.
- •Exclusion criteria for control subjects: 1.Depression 2.Anxiety, psychotic, substance abuse, mood and personality disorders 3.Major neurocognitive disorders such as Alzheimer's disease and other dementias 4.Neurologic disorders with anatomic lesions including traumatic brain injury, stroke, tumor and arteriovenous malformation
- •Exclusion criteria for depressed patients: 1.Psychotic disorders like schizophrenia 2.Major neurocognitive disorders such as Alzheimer's disease and other dementias 3.Neurologic disorders with anatomic lesions including traumatic brain injury, stroke, tumor and arteriovenous malformation 4.Not receiving clinical therapy for depression at SFVAMC'
研究组 & 干预措施
Non-Depressed Controls
Volunteers who have screened by a clinical psychiatrist, to exclude depression and other major psychiatric and neurocognitive disorders.
They will undergo NIRSIT testing to measure frontal blood oxygenation up to 3 times, with an interval of 3 weeks between each measurement.
干预措施: NIRSIT (Device)
Depressed Patients
Patients diagnosed with Major Depressive Disorder by a clinical psychiatrist. They will undergo NIRSIT testing to measure frontal blood oxygenation up to 5 times, with an interval of 3 weeks between each measurement, over the course of their clinical therapy for Major Depressive Disorder.
干预措施: NIRSIT (Device)
结局指标
主要结局
Change in Frontal Oxyhemoglobin concentration 3 weeks after initiation of treatment for MDD
时间窗: Each measurement is over 10 to 15 mins long, taken during the performance of VFT and CHR, 3 weeks after initiation of treatment for MDD.
Change in Oxyhemoglobin concentration in frontal blood from the baseline during the performance of Verbal Fluency Task (VFT) and Cartoon humor reaction task (CHR) by the subject.
Change in Frontal Oxyhemoglobin concentration 6 weeks after initiation of treatment for MDD
时间窗: Each measurement is over 10 to 15 mins long, taken during the performance of VFT and CHR, 6 weeks after initiation of treatment for MDD.
Change in Oxyhemoglobin concentration in frontal blood from the baseline during the performance of Verbal Fluency Task (VFT) and Cartoon humor reaction task (CHR) by the subject.
Change in Frontal Deoxyhemoglobin concentration before initiation of treatment for MDD
时间窗: Each measurement is over 10 to 15 mins long, taken during the performance of VFT and CHR, on the day of initiation of treatment for MDD, but before the treatment is given.
Change in Deoxyhemoglobin concentration in frontal blood from the baseline during the performance of Verbal Fluency Task and Cartoon humor reaction task by the subject.
Change in Frontal Deoxyhemoglobin concentration 6 weeks after initiation of treatment for MDD
时间窗: Each measurement is over 10 to 15 mins long, taken during the performance of VFT and CHR, 6 weeks after initiation of treatment for MDD.
Change in Deoxyhemoglobin concentration in frontal blood from the baseline during the performance of Verbal Fluency Task and Cartoon humor reaction task by the subject.
Change in Frontal Deoxyhemoglobin concentration 3 weeks after initiation of treatment for MDD
时间窗: Each measurement is over 10 to 15 mins long, taken during the performance of VFT and CHR, 3 weeks after initiation of treatment for MDD.
Change in Deoxyhemoglobin concentration in frontal blood from the baseline during the performance of Verbal Fluency Task and Cartoon humor reaction task by the subject.
Change in Frontal Oxyhemoglobin concentration before initiation of treatment for MDD
时间窗: Each measurement is over 10 to 15 mins long, taken during the performance of VFT and CHR, on the day of initiation of treatment for MDD, but before the treatment is given.
Change in Oxyhemoglobin concentration in frontal blood from the baseline during the performance of Verbal Fluency Task (VFT) and Cartoon humor reaction task (CHR) by the subject.
次要结局
- Patient Health Questionnaire-9 (PHQ-9) Scores(PHQ-9 is administered before each of the three NIRS measurement sessions; on the day of initiation of treatment for MDD, but before the treatment is given; 3 weeks after initiation of treatment and 6 weeks after the initiation of treatment.)
- Hamilton Depression Rating Scale (HAM-D) Score(HAM-D is administered before each of the three NIRS measurement sessions; on the day of initiation of treatment for MDD, but before the treatment is given; 3 weeks after initiation of treatment and 6 weeks after the initiation of treatment.)
- Beck's Depression Inventory - II (BDI-II) Scores(BDI-II is administered before each of the three NIRS measurement sessions; on the day of initiation of treatment for MDD, but before the treatment is given; 3 weeks after initiation of treatment and 6 weeks after the initiation of treatment.)