Effects of Endogenous Gamma Light Stimulation on Brain Oscillations in Cognitively-normal Older Adults: a Randomized, Placebo-controlled, Double-blind Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Changes in gamma brain oscillations.
研究概览
简要总结
This study aims to evaluate the effects of endogenous gamma non-flickering light stimulation on resting-state EEG rhythms and cognitive function in cognitively healthy older adults. Specifically, it will assess the immediate and long-term effects of this stimulation on brainwave activity and cognitive performance. The study will explore the potential of gamma light stimulation as a non-pharmacological intervention for cognitive decline in aging populations.
详细描述
Some Alzheimer's disease (AD) studies have investigated the effects of gamma-frequency light stimulation on healthy older adults and AD patients; they have several limitations, including small sample sizes, short intervention durations, the use of flickering light (which may cause discomfort), and lack of rigorous randomized controlled trials. The aim of this study is to address these gaps by conducting a randomized, placebo-controlled, double-blind trial.
This study will recruit 52 cognitively healthy older adults aged 55 and above (N= 52). Participants will be randomly assigned to either the experimental group (N=26), receiving endogenous gamma non-flickering light stimulation, or the control sham group (N=26), receiving 70 Hz non-flickering light stimulation. The intervention will consist of 1 hour of daily stimulation, 7 days a week, for a total of 4 weeks (28 hours). Both participants and outcomes assessors will remain blinded to group allocation.
Resting-state EEG and cognitive assessments will be conducted at three time points: prior to the intervention (T1), post one-hour intervention (T2), and post one-month intervention (T3). Resting-state brainwave activity will be the primary outcome, with data collected at all three time points (T1, T2, and T3). As secondary outcomes, cognitive assessments will be administered at T1 and T3. Adverse events will also be recorded by participants immediately following each light stimulation session.
The primary aim of this study is to assess the immediate (T2 relative to T1) and long-term (T3 relative to T1) effects of endogenous gamma light stimulation on resting-state brainwave activity. Secondary objectives include evaluating cognitive performance and assessing the safety, user acceptance, and adherence to the intervention device. The results of this study will provide valuable insights into the potential of endogenous gamma light stimulation as a non-pharmacological intervention for cognitive decline in aging populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age over 55 years old.
- •The Cognitive Abilities Screening Instrument (CASI) score is within normal ranges adjusted for age and education.
- •Participants have no history of severe neurological or psychiatric disorders (such as stroke, epilepsy, depression, migraine, etc.) that could affect cognitive function.
- •Participants have not used drugs that may affect cognitive function (e.g., benzodiazepines, anticholinergic medications, etc.).
- •Participants with normal or corrected vision (e.g., glasses or contact lenses) to normal levels.
- •Voluntary to sign the Informed Consent Form.
排除标准
- •Participants enrolled in any cognitive enhancement study within the past two months.
- •Participants with a history of disease that could affect cognitive function (e.g., cancer, autoimmune diseases, etc.).
- •Pregnant, or planning to become pregnant.
研究组 & 干预措施
endogenous gamma light
This device is an LED light source table lamp with a vertical surface measuring 16 cm by 22 cm. It will be positioned within arm's reach, approximately 50 cm from the participant, to ensure continuous exposure to the light stimulation. The active device delivers endogenous gamma light stimulation.
干预措施: Gamma Wave Stimulation Table Lamp (Aleddra, Inc., USA) (Device)
Sham (70Hz) gamma light
The sham device is identical in appearance to the active device. It will be positioned within arm's reach, approximately 50 cm from the participant, to ensure continuous exposure to the light stimulation. The sham device delivers 70 Hz light stimulation.
干预措施: Gamma Wave Stimulation Table Lamp (Aleddra, Inc., USA) (Device)
结局指标
主要结局
Changes in gamma brain oscillations.
时间窗: baseline (T1), post one-hour intervention (T2), post one-month intervention (T3)
Gamma (31-100Hz) brain oscillations obtained through resting-state EEG will evaluate the changes of gamma light stimulation intervention.
次要结局
- Change score of the category Verbal Fluency Test (VFT).(baseline (T1), post one-month intervention (T3))
- Subjective cognition decline complaint survey.(baseline (T1), post one-month intervention (T3))
- Change score of the Cognitive Abilities Screening Instrument (CASI).(baseline (T1), post one-month intervention (T3))
- Change score of the Chinese version Verbal Learning Test (CVVLT).(baseline (T1), post one-month intervention (T3))
- Change score of the WMS-III logical memory test(baseline (T1), post one-month intervention (T3))
- Change score of the Taylor Complex Figure Test (TCFT).(baseline (T1), post one-month intervention (T3))
- Performance changes of the Trail Making Test Form A/B (TMT-A/B).(baseline (T1), post one-month intervention (T3))
- Safety/Adverse event outcome measure.(Throughout the one-month intervention)