Clinical trial NCT03551392: Pilot Intervention With Near Infrared Stimulation
Official title: Pilot Intervention With Near Infrared Stimulation: Revitalizing Cognition in Older Adults and Those With Parkinson Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aging
Keywords: Cognitive Aging
Photobiomodulation
Low Level Light Therapy
Near Infrared (NIR) Light
Neuromodulation
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: McKnight Brain Research Foundation
name: University of Arizona
First posted: 2018-06-11
Enrollment: 24
Sex: ALL
Minimum age (years): 65
Maximum age (years): 89
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a blinded parallel group sham controlled pilot trial, with half the participants in each group randomized to the real NIR treatment and half to the sham treatment condition.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: ARENA, learning and memory change from baseline to post-testing
timeFrame: Baseline to one-week post intervention (approx Week 14)
Secondary outcomes:
measure: NIH Examiner, Verbal Fluency Domain Score change from baseline
timeFrame: Change in baseline to one-week post intervention (approx Week 14)
measure: NIH Examiner, Working Memory Domain score change from baseline
timeFrame: Change in baseline to one-week post intervention (approx Week 14)
measure: NIH Examiner, Cognitive Control Domain score change from baseline to post-testing
timeFrame: Change in baseline to one-week post intervention (approx Week 14)
measure: NIH Toolbox Emotion Negative Affect Scale change from baseline to post-testing
timeFrame: Baseline to one-week post-intervention (approx Week 14)
measure: NIH Toolbox Emotion-Psychological Well Being Scale change from baseline
timeFrame: Change in baseline to one-week post intervention (approx Week 14)
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Dawn Bowers, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Adam Woods, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arizona
name: Gene Alexander, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: