Assessing the Effect of 1072nm Infrared (IR) Phototherapy on the Behavioral and Cognitive Symptoms Associated With Early and Mid-stage Dementia: a Randomized Placebo-controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Alzheimer Disease Assessment Scale-Cognitive (ADAS-Cog) Delayed Word Recall.
研究概览
简要总结
This study will employ a double-blind, placebo-controlled approach to assess the effect of 1072nm infrared (IR) phototherapy on the behavioral and cognitive symptoms associated with early and mid-stage dementia.
详细描述
What hypotheses are you testing?
We are seeking to determine if the provision of brief, repeated exposure to 1072nm infrared stimulation of the cortex surface improves cognitive and behavioral functioning as indicated by normalization of EEG activity, increased cerebral oxygenation and demonstrated improvement on standardized neuropsychological measures.
Intensive near infrared stimulation has been shown to be effective in accelerating healing of injuries and functional modification including increasing blood flow and perfusion. Dementia research has suggested that hypoperfusion is a significant underlying mechanism in the progression of dementia. Infrared spectroscopy has been shown effective in the non-invasive measurement of changes in cerebral oxygenation and perfusion. This study therefore seeks to explore whether the increasing of regional cerebral perfusion and oxygenation using infrared light stimulation will result in improved cognitive and behavioral functioning.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 50 - 85 years.
- •Have established cognitive impairment, Mini Mental Status Examination (MMSE) score between 15- 25 (from a possible score of 30).
- •Generally healthy otherwise as indicated by recent physical examination.
- •Have a caregiver/informant who has cared for the patient at least 5 days a week and is willing to attend study visits and provide information about the patient.
- •If taking any psychotropic medication should have been stable for the previous 3 months.
- •Must have had B12, folic acid, full blood count and ferritin screen within the previous 6 months or be on B12 and/or folic acid replacement.
排除标准
- •Uncontrolled or unstable chronic illness, e.g., hypertension, chronic obstructive pulmonary disease (COPD).
- •Diagnosed actively growing intracranial pathology (tumors etc).
- •An associated psychotic illness.
- •Misusing illegal substances or alcohol.
- •On regular systemic steroids or anti-metabolites.
- •Systemic malignancies and/or space occupying lesions in the brain.
- •Not fluent in English.
- •Depressed as assessed by Beck Depression Inventory score.
- •Epilepsy.
- •Lacking the capacity to give informed consent.
- •Previous history of stroke or heart attack.
- •History of aggression or violence.
- •Inability to travel to the research venue for multiple assessments.
- •A history of major psychiatric illness, seizure disorder, or physical illness that would compromise their participation in a daily treatment regimen.
- •A participant may be disqualified if their performance is above the normative mean or below the lowest interpretable score of neuropsychological tests provided during the initial assessment (see #6, Sources of research material obtained from study participants, below).
结局指标
主要结局
Alzheimer Disease Assessment Scale-Cognitive (ADAS-Cog) Delayed Word Recall.
时间窗: Post-tx (total intervention period = 28 days) scores to be compared to baseline scores.
Delayed Word Recall is a subscale of the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog), a measure of cognitive impairment. Higher scores indicate greater impairment. Range: 0-10. Measures were taken within 72 hours of the first day of treatment and within 72 hours following the 28th day of treatment. Outcome measure was calculated by subtracting pretest from post test ADAS-Cog measurements.
次要结局
未报告次要终点
研究者
Marvin H. Berman, Ph.D.
clinical trial coordinator
Quietmind Foundation