Pilot Intervention With Near Infrared Stimulation: Revitalizing Cognition in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- ARENA, learning and memory change from baseline to post-testing
研究概览
简要总结
The current study will test whether age-related cognitive and mood changes in older adults and those will be affected by near infrared (NIR) stimulation. The overall hypothesis, drawn from previous literature, is that exposure to NIR stimulation will have positive effects on brain health and will result in better cognitive and mood performance.
详细描述
This is a multi-site pilot study of the efficacy of NIR stimulation for enhancing cognition and mood in nondemented older adults. Sites include the University of Florida and University of Arizona. Prior research suggests that NIR exposure may be neuroprotective and increases energy available to neurons. The current study will test whether age-related cognitive and mood changes in older adults will be affected by near infrared (NIR) stimulation.
The study team will randomize older adults into treatment groups and evaluate neuroimaging and cognitive outcome measures, before and after a 12-week intervention involving transcranial and intranasal NIR. The protocol will involve both " lab" and " home-based" NIR stimulation. The overall hypothesis, drawn from previous literature, is that exposure to NIR stimulation will have positive effects on brain health and will result in better cognitive and mood performance.
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)
盲法说明
Research assistants who administer pre and post measures will be masked, as well as participants who receive the intervention.
入排标准
- 年龄范围
- 65 Years 至 89 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No evidence of dementia or Mild Cognitive Impairment based on cognitive screening (i.e., Montreal Cognitive Assessment (MoCA) scores within normal limits for age , education, and sex using the NACC Uniform Data Set (UDS) norms or Dementia Rating Scale (DRS-2) scores <5thile), and age-appropriate delayed Story recall (i.e., WMS-III Logical Memory) and confrontation naming (Boston Naming Test)
- •Able to provide informed consent and perform cognitive and mood measures on a computer
- •At least 8th grade education and/or ability to read at 8th grade level
- •Willingness to be randomized to Sham or Real intervention
- •Can devote 12 weeks to the intervention, and additional time for pre and post testing
- •On stable doses of major medications; Since some older adults with subjective memory complaints may be prescribed acetylcholinererase inhibitors or related medications by their primary care physicians (i.e., donepezil, rivastigmine, galantaominhe, memantime, or other potential memory-enhancing agent(s), we will not exclude them as long as they have been on stable medications for at least two months and plan to continue this medication during study participation.
- •Normal functional behavior in terms of daily activities
排除标准
- •Previous major strokes or other known significant brain abnormalities or diseases affecting cognition (i.e., multiple sclerosis, seizure disorder, brain surgery, moderate TBI, etc.). No history of brain surgery. Exceptions are a diagnosis of Parkinson's disease for the PD subgroup.
- •Unstable and uncontrolled medical conditions (metabolic encephalopathy, HIV, moderate to severe kidney or liver disease)
- •Current or past history of major psychiatric disturbance including schizophrenia, or active psychosis, bipolar disorder, current major depressive episode, current alcohol or substance abuse or history thereof within the past six months. The study team is not excluding individuals who are taking antidepressants or anti-anxiety medications, however, use of antidepressants and anxiolytics will be recorded and data will be analyzed in post-hoc analyses
- •Use of antipsychotics, sedatives, or other medications with significant anticholinergic properties (due to potential influence on memory)
- •Use of photo-sensitive medications such as steroids or retin-A within 15 days of the study intervention
- •Diagnosis of active cancer
- •Significant motor or visual disturbance that would prevent one from using a computer or detecting colors
- •Previous participation in a cognitive training study within the last 3 months or current involvement in another study involving cognitive training or intervention at the time of participation
- •Inability to undergo brain imaging due to claustrophobia or implants such as pacemakers, heart valves, brain aneurysm clips, orthodontics, non-removable body jewelry, or shrapnel containing ferromagnetic metal
研究组 & 干预措施
No Dose NIR-Older Adult
Older adult participants receive the sham Medx Console System and the sham Vielight 810 intranasal stand alone unit, since the devices deliver no near infrared light. These sham interventions occur during 16 lab sessions (1.5 hours each) during an 12 week period, plus daily 25 minute 'at home' intranasal stimulation interventions, 4 days each week.
干预措施: Sham Vielight 810 intranasal stand alone unit (Device)
NIR -Older Adult
Older adult participants receive the Medx Console System and the Vielight 810 intranasal stand alone unit. These interventions occur during 16 lab sessions (1.5 hours each) during an 12 week period, plus daily 25 minute 'at home' intranasal stimulation interventions, 4 days each week.
干预措施: Medx Console System (Device)
NIR -Older Adult
Older adult participants receive the Medx Console System and the Vielight 810 intranasal stand alone unit. These interventions occur during 16 lab sessions (1.5 hours each) during an 12 week period, plus daily 25 minute 'at home' intranasal stimulation interventions, 4 days each week.
干预措施: Vielight 810 intranasal stand alone unit (Device)
No Dose NIR-Older Adult
Older adult participants receive the sham Medx Console System and the sham Vielight 810 intranasal stand alone unit, since the devices deliver no near infrared light. These sham interventions occur during 16 lab sessions (1.5 hours each) during an 12 week period, plus daily 25 minute 'at home' intranasal stimulation interventions, 4 days each week.
干预措施: Sham Medx Console System (Device)
结局指标
主要结局
ARENA, learning and memory change from baseline to post-testing
时间窗: Baseline to one-week post intervention (approx Week 14)
Spatial navigation and memory task yields a score consisting of percent time spent in the target quadrant during the probe trial.
次要结局
- NIH Examiner, Verbal Fluency Domain Score change from baseline(Change in baseline to one-week post intervention (approx Week 14))
- NIH Examiner, Working Memory Domain score change from baseline(Change in baseline to one-week post intervention (approx Week 14))
- NIH Examiner, Cognitive Control Domain score change from baseline to post-testing(Change in baseline to one-week post intervention (approx Week 14))
- NIH Toolbox Emotion Negative Affect Scale change from baseline to post-testing(Baseline to one-week post-intervention (approx Week 14))
- NIH Toolbox Emotion-Psychological Well Being Scale change from baseline(Change in baseline to one-week post intervention (approx Week 14))