Revitalize Cognition: A Proof of Concept Study Using Transcranial Near Infrared Stimulation in Older Adults
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Aging
- Sponsor
- University of Florida
- Enrollment
- 16
- Locations
- 2
- Primary Endpoint
- NIH Examiner Battery, Executive Composite Changes From Baseline to Post-testing
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 62 years or above
- •Able to provide informed consent and perform cognitive and mood measures on a computer
- •Willingness to be randomized to Sham or Real intervention
- •Can devote 2 weeks to the intervention, and additional time for pre and post testing
- •8th grade education and ability to read on 8th grade level based on scores on the Wechsler Test of Adult Reading (WTAR) or the Wide Range Achievement Test-IV (WRAT-IV); or a reading test at 14 pt. text
- •On stable doses of major medications; Since some older adults with 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.
- •Willingness to allow a study partner (spouse, family member, friend) to answer questions about their cognitive, mood, and other behaviors
- •Exclusion criteria
- •Sensory loss (vision, hearing) or motor deficits that would preclude participation in the experimental cognitive tasks or neuropsychological assessment
- •Unstable and uncontrolled medical conditions (metabolic encephalopathy, HIV, moderate to severe kidney or liver disease)
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
NIH Examiner Battery, Executive Composite Changes From Baseline to Post-testing
Time Frame: Change in baseline to approximately week 3
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.
Secondary Outcomes
- Composite Learning-Retention Score From ARENA Task(Change in baseline to approximately week 3)
- NIH Toolbox Emotion Psychological Wellbeing Scale Changes From Baseline to Post-testing(Change in baseline to approximately week 3 (Post - Baseline))
- NIH Toolbox Emotion Negative Affect Scale Changes From Baseline to Post-testing(Change from baseline to approximately week 3 (Post Intervention - Baseline))