A Pilot Study to Evaluate the Ability of Photobiomodulation to Alter Cerebral Blood Flow in the Frontal Poles and to Affect the Emotional Status of Patients With Major Depression
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Hamilton Depression Rating Scale
研究概览
简要总结
A pilot study to evaluate the ability of photobiomodulation to alter cerebral blood flow in the frontal poles and to affect the emotional status of patients with major depression.
详细描述
We wish to study whether photobiomodulation (PBM) with near infrared (NIR) light emitting diodes (LED), a non-ionizing phototherapy, in patients with major depression, can acutely alter frontal brain blood flow measured by near infrared spectroscopy (NIRS).
Secondarily, we will examine whether PBM can improve emotional state immediately and over the following month.
We see this as a pilot study to gather preliminary data that will guide future studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients must be right handed, between the ages of 18 and 60, and meet criterion for depression on a Structured Clinical Diagnostic Interview
- •Enrollment will be made without regard to gender or ethnicity
- •Patients who are receiving treatment for depression, either psychological or pharmacological, may continue their treatment during the time of the study, but will be asked to try not to alter their treatment from one month prior to the onset of the experiment until its conclusion. If they must alter their treatment, the patient will continue in the study for observation, but will be excluded from any follow-up statistical comparisons
排除标准
- •Past history of psychotic disorder (including schizophrenia or schizoaffective disorder
- •Bipolar disorder
- •Obsessive compulsive disorder)
- •Substance abuse disorder that has been active with the past 6 months,
- •A history of violent behavior
- •A history of a past suicide gesture or attempt
- •A history of current suicidal ideation
- •A history of a neurological condition (e.g. epilepsy, traumatic brain injury, stroke)
- •Pregnancy
- •Current acute or chronic medical condition requiring a medications that has psychological side-effects
- •Any person whom we judge to have an impaired decision-making capacity
结局指标
主要结局
Hamilton Depression Rating Scale
时间窗: Before treatment (baseline), 2-weeks after treatment, and 4-weeks after treatment
次要结局
- Hamilton Anxiety Rating Scale(Before treatment (baseline), 2-weeks after treatment, and 4-weeks after treatment.)