Actively Recruiting
Pilot Study of Near Infrared Stimulation to Improve Cognition and Mood in Older Adults and People with Parkinson Disease
Led by University of Florida · Updated on 2025-01-27
24
Participants Needed
2
Research Sites
357 weeks
Total Duration
On this page
Sponsors
U
University of Florida
Lead Sponsor
M
McKnight Brain Research Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether near infrared (NIR) stimulation can improve cognitive function and mood in older adults without dementia. This multi-site pilot study involves participants aged 65 to 89 years and aims to test the neuroprotective effects of NIR, which may increase energy availability to brain cells and enhance brain health. The study includes those with normal cognitive screening results and no evidence of dementia or mild cognitive impairment. Participants are randomly assigned to receive either real or sham NIR stimulation using devices that deliver light through the head and intranasal applicators. The intervention includes 16 lab sessions over 12 weeks, each lasting about 1.5 hours, combined with daily home-based intranasal NIR sessions lasting 25 minutes, four days per week. Both transcranial and intranasal methods are used to deliver NIR. During the study, participants undergo cognitive and mood assessments on a computer before and after the intervention period. Researchers will also conduct neuroimaging and monitor medication stability, functional behavior, and safety. The primary outcome focuses on changes in learning and memory from baseline to one week after completing the intervention, approximately week 14 in total.
CONDITIONS
Official Title
Pilot Intervention With Near Infrared Stimulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- No evidence of dementia or mild cognitive impairment based on cognitive screening tests within normal limits for age, education, and sex
- Able to provide informed consent and perform cognitive and mood tests on a computer
- At least 8th grade education or ability to read at an 8th grade level
- Willingness to be randomized to receive real or sham intervention
- Able to commit to 12 weeks of intervention plus time for pre- and post-testing
- On stable doses of major medications for at least two months and plan to continue during study participation
- Normal daily functional behavior
You will not qualify if you...
- History of major strokes or significant brain diseases affecting cognition, including brain surgery (except Parkinson's disease subgroup)
- Unstable or uncontrolled medical conditions such as metabolic encephalopathy, HIV, moderate to severe kidney or liver disease
- Current or past major psychiatric disorders including schizophrenia, active psychosis, bipolar disorder, major depressive episode, alcohol or substance abuse within the past six months
- Use of antipsychotics, sedatives, or medications with significant anticholinergic effects
- Use of photosensitive medications like steroids or retin-A within 15 days before intervention
- Diagnosis of active cancer
- Significant motor or visual impairments preventing computer use or color detection
- Participation in cognitive training studies within the last 3 months or current involvement in other cognitive intervention studies
- Inability to undergo brain imaging due to claustrophobia or presence of implants such as pacemakers, heart valves, brain aneurysm clips, orthodontics, non-removable body jewelry, or ferromagnetic shrapnel
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University of Arizona
Tucson, Arizona, United States, 85721
Actively Recruiting
2
University of Florida
Gainesville, Florida, United States, 32611
Actively Recruiting
Research Team
D
Dawn Bowers, Ph.D.
A
Adam Woods, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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