Changes in mood and cognition are common in older adulthood. Some studies have suggested that transcranial application of near-infrared (NIR) light may have enhancing effects on cognitive and mood status in young adults and individuals with traumatic brain injury. This effect has not been examined in older adults. This study will involve a randomized sham-controlled trial to learn whether NIR stimulation improves cognition and mood in older adults, relative to sham treated controls. Aim 4 of this study (Parkinson Specific) is registered separately under NCT06688357
There is a dearth of clinically meaningful treatment options at this point in time for individuals who are at increased risk for transitioning to dementia, particularly those with the amnestic variant of mild cognitive impairment (aMCI). While waiting for causative cures and preventive approaches, investigators are faced with the task of identifying modifying therapies that might alter the course or slow down the transition from normal cognition to MCI to dementia. The proposed study hopes to contribute to this mission by testing the viability of a different type of intervention, one involving transcranial delivery of near-infrared (NIR) wavelengths (808-904nm). Near-infrared stimulation is safe, non-invasive and appears to improve mitochondrial function by promoting increased production of intracellular adenosine triphosphate (ATP) and possibly improved blood flow. Perhaps most compelling are recent findings of reduced beta-amyloid and neurofibrillary tangles in transgenic Alzheimer's mouse models after exposure to real vs sham transcranial NIR stimulation. Preliminary human involving traumatic brain injury (TBI), stroke, and young adult populations have also been promising in terms of positive effects of NIR on cognition. The overall goal of the present study is to learn whether this unconventional NIR stimulation approach has potential for improving cognition in older adults. To do so, investigators will conduct a randomized sham controlled pilot trial. The intervention will involve six sessions, over a 2-week period in which real or sham stimulation is transcranially applied using a delivery system that has been FDA-approved as a nonsignificant risk since 2003. Researchers hope to learn whether NIR stimulation, relative to sham, has positive effects on cognition and mood in older adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
16
This intervention makes use of transcranially applied near infrared light using light emitting diodes. Near infrared light will be applied to the scalp for a period of 1 hour at each session. A total of six session will be held.
This intervention makes use of sham transcranially applied near infrared light using light emitting diodes. Light emitting diodes (but not near-infrared light) will be applied to the scalp for a period of 1 hour at each session. A total of six session will be held.
The Center for Movement Disorders and Neurorestoration
Gainesville, Florida, United States
The Village Retirement Community
Gainesville, Florida, United States
NIH Examiner Battery, Executive Composite Changes From Baseline to Post-testing
Computer-based battery of executive functioning tests which yields a total or "composite" score to represent global executive functioning. Executive composite scores can range from -3.0 to 3.0, with higher scores corresponding to better executive functioning, 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 approximately week 3
Composite Learning-Retention Score From ARENA Task
ARENA is a task of spatial memory and navigation that is a human analogue to the Morris water maze used in animal studies. Participants learn to navigate to a hidden target location relying on spatial cues in a simulated environment over a series of 8 learning trials and a final retention trial. The final ARENA outcome is an Overall Composite z-score combining learning and retention metrics as follows: \[-Learning z-score + Retention z-score\]/2. The learning z-score is based on two metrics (path length to target, time to reach target) that are converted to z-scores and averaged over the 8 learning trials. The retention z-score is based on percent time spent in the target quadrant during the retention trial. The Learning and Retention z-scores are combined to create a single final Arena Composite outcome. Higher composite scores reflect better memory performance. A change score is calculated by subtracting the Baseline Composite score from the post-test Composite Score
Time frame: Change in baseline to approximately week 3
NIH Toolbox Emotion Psychological Wellbeing Scale Changes From Baseline to Post-testing
The Psychological Wellbeing Scale from the NIH Toolbox Emotion module Wellbeing Scale results in T-scores (mean=50, SD=10) for categories such as positive affect, life satisfaction, and meaning and purpose. Scores below 40 indicate low levels of wellbeing and scores above 60 indicating high levels of wellbeing. Change scores will be calculated by subtracting the baseline scores from the post-test scores.
Time frame: Change in baseline to approximately week 3 (Post - Baseline)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
NIH Toolbox Emotion Negative Affect Scale Changes 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 and scores above 60 indicate high levels of negative affect. Change scores will be calculated by subtracting the baseline scores from the post-test scores.
Time frame: Change from baseline to approximately week 3 (Post Intervention - Baseline)