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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
24
This intervention delivers near infrared (NIR) light using light emitting diodes applied to the head and via an intranasal applicator for a period of approximately 1.5 hours. A total of 16 sessions take place in the lab over 12 weeks.
This intervention uses sham application of near infrared light (NIR) using light emitting diodes applied to the head and via an intranasal applicator for a period of approximately 1.5 hours. A total of 16 sessions take place in the lab over 12 weeks.
Daily at home intranasal NIR stimulation sessions, 25 minutes in duration, 4 days each week.
University of Arizona
Tucson, Arizona, United States
RECRUITINGUniversity of Florida
Gainesville, Florida, United States
RECRUITINGARENA, learning and memory change from baseline to post-testing
Spatial navigation and memory task yields a score consisting of percent time spent in the target quadrant during the probe trial.
Time frame: Baseline to one-week post intervention (approx Week 14)
NIH Examiner, Verbal Fluency Domain Score change from baseline
The Verbal Fluency domain from the NIH Examiner involves speeded production of letter and semantic cued words. Verbal fluency composite score can range from -3.0 to 3.0, with higher scores corresponding to better fluency performance and negative scores indicating impairment. A change score will be calculated by subtracting the baseline scores from the post test scores.
Time frame: Change in baseline to one-week post intervention (approx Week 14)
NIH Examiner, Working Memory Domain score change from baseline
Computer based battery of working memory tasks that yields a composite score based on Dot Counting total score and d-prime measures from the N-back task. Composite score ranges from -3.0 to 3.0, with higher scores corresponding to better working memory performance. A change score will be calculated by subtracting the baseline scores from the post test scores.
Time frame: Change in baseline to one-week post intervention (approx Week 14)
NIH Examiner, Cognitive Control Domain score change from baseline to post-testing
The Cognitive Control domain from the NIH Examiner yields a composite score based on individual scores from the Flanker task, the Continuous Performance task, and the Set-Shifting task. Composite score ranges from -3.0 to 3.0, with higher scores corresponding to better cognitive control performance. A change score will be calculated by subtracting the baseline scores from the post test scores.
Time frame: Change in baseline to one-week post intervention (approx Week 14)
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Daily at home intranasal "sham" NIR stimulation sessions, 25 minutes in duration, 4 days each week.
NIH Toolbox Emotion Negative Affect Scale change from baseline to post-testing
The Negative Affect Scale from the NIH Toolbox Emotion module results in T-scores (mean=50, SD=10) for categories such as anger, sadness, and apathy. Scores below 40 indicate low levels of negative affect. Change scores will be calculated by subtracting the baseline scores from the post-test scores.
Time frame: Baseline to one-week post-intervention (approx Week 14)
NIH Toolbox Emotion-Psychological Well Being Scale change from baseline
The Psychological Well-being Scale from the NIH Toolbox Emotion module results in T-scores (mean=50, SD=10) for categories such general life satisfaction, meaning and purpose, and positive affect. Scores below 40 indicate low levels of positive affect. Change scores will be calculated by subtracting the baseline scores from the post-test scores.
Time frame: Change in baseline to one-week post intervention (approx Week 14)