A Pilot Clinical Trial for the Efficacy and Safety of Transcranial Photobiomodulation (tPBM) in Improving Symptoms of Bipolar Depression
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Montgomery-Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
This study the effectiveness and safety of light therapy device targeted at the brain using a wearable device, the Vielight RX Gamma as a treatment for bipolar depression. Up to forty patients with bipolar disorder will be enrolled into the study and will either receive active treatment with the Vielight RX Gamma or sham (inactive device). They will be administered the devices in clinic 5days/week for 6 weeks. Changes in disease symptoms, cognitive function, pain, quality of life and rest EEG changes will be assessed.
详细描述
Photobiomodulation (PBM) refers to the application of low levels of red or near-infrared (NIR) light to either stimulate or inhibit biological cells and tissues involving photochemical mechanisms. Transcranial PBM (tPBM), targeting delivery of light energy to the brain, is associated with increased cerebral blood flow, oxygen availability and consumption, adenoside triphophosphate (ATP) production, and improved mitochondrial activity. More recently, tPBM has demonstrated its value as a treatment for neurological and neurodegenerative conditions. Evidence of mitochondrial dysfunction in patients with BD suggests that PBM may have therapeutic benefits for patients with BD. The primary objective of this study is to confirm the safety and efficacy of using tPBM at 40Hz stimulation in improving symptoms of depression in patients diagnosed with bipolar depression.The study will be a single-blind randomized sham-controlled pilot trial with subjects receiving treatment 5 days/week for 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Diagnosis of bipolar depression
- •Montgomery-Asberg Depression Rating Scale (MADRS) of 24 or higher
- •Capable of providing consent
- •Currently inpatient or outpatient
- •Ability to communicate in spoken and written English fluently enough to complete the required study assessments
排除标准
- •Currently in manic or mixed episode, as measured by Young Mania Rating Scale (YMRS) more than 8-10
- •Currently psychotic
- •Judged to be at serious and imminent suicidal risk
- •Currently has alcohol or substance use disorder (meeting criteria in the past 1 months)
- •Unstable medical conditions
- •Inability to consent or to complete study procedures
- •Changes in medications or use of augmentative devices and other interventions in the 4 weeks prior to the study
- •Participation in other clinical research trials that may influence primary outcomes or adherence to the proposed study
- •Current pregnancy or intention to become pregnant
研究组 & 干预措施
Sham (inactive Neuro Rx Gamma)
Participants assigned to this arm will be administered the sham device in clinic 5 days per week for 6 weeks
干预措施: Sham Device (Device)
Neuro Rx Gamma
Treatment with Neuro Rx Gamma
干预措施: Vielight Neuro Rx Gamma (Device)
结局指标
主要结局
Montgomery-Asberg Depression Rating Scale (MADRS)
时间窗: Baseline to week 6
Change in depression symptoms as measured by the Montgomery-Asberg Depression ( Rating Scale (MADRS). Scale is from 0-60, with higher score indicating high depression severity.
次要结局
- World Health Disability Assessment Schedule 2.0 (WHODAS 2.0)(Baseline to week 6)
- Clinical Global Impression Scale-Bipolar(Change from baseline to week 6)
- Trails Making Test(Baseline to week 6)
- N-Back (2-Back)(Baseline to week 6)
- Pain Visual Analog Scale(Baseline to week 6)
- Rest electroencephalography (5min rest, eyes closed)(Baseline to week 6)
- Stanford expectancy scale ratings(Baseline)
- Young Mania Rating Scale (YMRS)(Baseline to week 6)
- Columbia-Suicide Severity Rating Scale (C-SSRS)(Baseline to week 6)