Effectiveness of Light for Enhancement of Cognition by Transcranial Repeated Application (ELECTRA): a Placebo-Controlled Study of Efficacy, Tolerability and Acceptability in Healthy Adult Volunteers
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- RTI: Reaction Time
研究概览
简要总结
Aim: Investigate whether transcranial photobiomodulation (tPBM) using near-infrared light exposure to the head, can improve frontal lobe executive function, working memory and overall mood in normal volunteer participants.
Hypothesis: The investigators predict that tPBM will increase cognitive functioning, as measured by Cambridge Cognition cognitive testing in study subjects.
详细描述
Photobiomodulation (PBM), also called low-level light therapy (LLLT), uses optical power densities less than 100 mW/cm², and usually in the red (600-700 nm) or near infrared (NIR) 780-1000 nm wavelength range. Different light sources (coherent lasers or non-coherent LEDs) used for PBM have been shown to produce beneficial cellular effects and to be responsible for preservation and recovery of tissue function in controlled trials in a wide range of disorders typified by stress injury or degeneration. During PBM, absorption of red or near-infrared photons by cytochrome c oxidase in the mitochondrial respiratory chain causes an increase in cellular respiration that continues for much longer than the light is present when delivered at appropriate fluence and exposure durations.
Primary cellular effects include increases in mitochondrial activity and ATP levels, production of low levels of reactive oxygen species, induction of transcription factors (including the pro- survival NF-kB), and inhibition of apoptosis.
Over the past decade several studies have reported that a single, transcranial PBM treatment at 810 nm delivered to the head had significant, beneficial effect when used to treat acute ischemic stroke in several different animal models and also in human clinical trials. A similar approach was used to treat acute traumatic brain injury (TBI) in mice and in humans. Pathological examination of the mouse brains demonstrated up- regulation of brain-derived neurotrophic factor (BDNF) and stimulated neurogenesis in the hippocampus and increased synaptogenesis in the cortex.
A clinical trial is currently in progress at MGH to treat persons with acute moderate TBI. Several studies have shown improvement of cognitive function in persons with chronic TBI. Studies have also been conducted in animal models and in persons with Alzheimer's disease, Parkinson's disease, depression and anxiety.
Only a very limited number of studies have so far been carried out to test NIR photobiomodulation in normal experimental rodents and in normal human volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18-25 or 65-85
- •Women of child-bearing potential, must use a double-barrier method for birth control (e.g. condoms with spermicide) if sexually active during the study and for 30 days post treatment of any kind.
- •Subject Informed Consent obtained in writing in compliance with local regulations prior to enrollment into this study.
- •The subject (and caregiver, if applicable) is willing to participate in this study for at least 12 weeks.
排除标准
- •Inability to speak or read English (necessary for cognitive testing software use).
- •Pregnancy or lactation
- •History of stroke or traumatic brain injury
- •Substance dependence or abuse in the past 6 months
- •Diagnosis with major psychiatric disease (Psychotic disorder or psychotic episode, bipolar affective disorder)
- •Diagnosed with a neurodevelopmental condition (autism or ADHD)
- •A traumatic event that resulted in PTSD
- •Any unstable medical illness (defined as any medical illness which has not been well-controlled with standard-of-care medications)
- •A significant skin condition (i.e., hemangioma, scleroderma, rash, open wound) or medical implant (e.g. metal plate, implantable shunt or valve) on the head.
- •Inability to understand or participate in the consent and performance of the study.
- •Those with Parkinson's Disease, End Stage Renal Disease, and/or End Stage Liver Disease
研究组 & 干预措施
NIR brain stimulation
An Omnilux device will be used to put NIR light on the head and forehead of the subject age 18-25 or 65-85. The device is a low risk device as determined by the IRB. Thirty (30) subjects will receive this light at 6 visits over 16 weeks.
An automated interactive software self-test will be used at baseline and at three subsequent visits to quantify subject cognitive functions.
干预措施: Omnilux (Device)
Sham
An Omnilux Device will be used at a safe wavelength not associated with photobiomodulation, putting sham light on the head and forehead of the subject age 18-25 or 65-85. The device is a low risk device as determined by the IRB. Thirty (30) subjects will receive this light at 6 visits over 16 weeks.
An automated interactive software self-test will be used at baseline and at three subsequent visits to quantify subject cognitive functions.
干预措施: Omnilux (Device)
结局指标
主要结局
RTI: Reaction Time
时间窗: 16 weeks
The mean duration between the onset of the stimulus and the release of the button. Calculated for correct, assessed trials where the stimulus could appear in any one of five locations.
SST: Stop Signal Task
时间窗: 16 weeks
The estimate of the length of time between the go stimulus and the stop stimulus at which the subject is able to successfully inhibit their response on 50% of the trials.
SWM: Spatial Working Memory
时间窗: 16 weeks
Between errors are defined as times the subject revisits a box in which a token has previously been found. This is calculated for trials of four, six and eight tokens.
PAL: Paired Associates Learning
时间窗: 16 weeks
The number of times the subject chose the incorrect box for a stimulus on assessment problems, plus an adjustment for the estimated number of errors they would have made on any problems, attempts and recalls they did not reach
RVP: Rapid Visual Information Processing
时间窗: 16 weeks
A' (A prime) is the signal detection measure of sensitivity to the target, regardless of response tendency (the expected range is 0.00 to 1.00; bad to good). In essence, this metric is a measure of how good the subject is at detecting target sequences.
ERT: Emotional Recognition Task
时间窗: 16 weeks
The median latency from stimulus onset to the subject's response button touch (i.e. emotion chosen) for all problems during assessment blocks.
次要结局
未报告次要终点
研究者
Richard Rox Anderson, MD
Director, Wellman Center for Photomedicine
Massachusetts General Hospital