Study Summary
This trial will test the effects of near infrared light on cognitive performance and mood in older adults and those with Parkinson's disease.
Eligible Conditions
- Aging
- Parkinson's Disease
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 6 Secondary · Reporting Duration: Baseline to one-week post intervention (approx Week 14)
Week 14
ARENA, learning and memory change from baseline to post-testing
Week 14
NIH Toolbox Emotion Negative Affect Scale change from baseline to post-testing
Week 14
NIH Examiner Executive Composite Score change from baseline to post-testing
Week 14
NIH Examiner, Cognitive Control Domain score change from baseline to post-testing
NIH Examiner, Verbal Fluency Domain Score change from baseline
NIH Examiner, Working Memory Domain score change from baseline
NIH Toolbox Emotion-Psychological Well Being Scale change from baseline
Trial Safety
Safety Progress
Trial Design
4 Treatment Groups
NIR -Parkinson
1 of 4
NIR -Older Adult
1 of 4
No Dose NIR-Parkinson
1 of 4
No Dose NIR-Older Adult
1 of 4
Active Control
Non-Treatment Group
135 Total Participants · 4 Treatment Groups
Primary Treatment: NIR -Parkinson · Has Placebo Group · N/A
NIR -ParkinsonActiveComparator Group · 2 Interventions: Medx Console System, Vielight 810 intranasal stand alone unit · Intervention Types: Device, Device
No Dose NIR-ParkinsonShamComparator Group · 2 Interventions: Sham Medx Console System, Sham Vielight 810 intranasal stand alone unit · Intervention Types: Device, Device
NIR -Older AdultActiveComparator Group · 2 Interventions: Medx Console System, Vielight 810 intranasal stand alone unit · Intervention Types: Device, Device
No Dose NIR-Older AdultShamComparator Group · 2 Interventions: Sham Medx Console System, Sham Vielight 810 intranasal stand alone unit · Intervention Types: Device, Device
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to one-week post intervention (approx week 14)
Who is running the clinical trial?
University of FloridaLead Sponsor
1,251 Previous Clinical Trials
698,678 Total Patients Enrolled
McKnight Brain Research FoundationUNKNOWN
1 Previous Clinical Trials
40 Total Patients Enrolled
University of ArizonaOTHER
464 Previous Clinical Trials
157,348 Total Patients Enrolled
Gene Alexander, Ph.D.Principal InvestigatorUniversity of Arizona
1 Previous Clinical Trials
168 Total Patients Enrolled
Adam Woods, Ph.D.Principal InvestigatorUniversity of Florida
Dawn Bowers, Ph.D.Principal InvestigatorUniversity of Florida
3 Previous Clinical Trials
288 Total Patients Enrolled
Eligibility Criteria
Age 65 - 89 · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:We will not exclude older adults with subjective memory complaints who are taking acetylcholinererase inhibitors or related medications, as long as they have been on stable medications for at least two months and plan to continue this medication during study participation.
No evidence of dementia or Mild Cognitive Impairment (MCI) based on cognitive screening (e.g., MoCA scores within normal limits for age , education, and sex using the NACC Uniform Data Set (UDS) norms or DRS-2 scores <5thile), and age-appropriate delayed Story recall (e.g., WMS-III Logical Memory) and confrontation naming (Boston Naming Test).
This person is able to consent and measure cognitive and mood abilities on a computer.
At least 8th grade education or equivalent skills in reading.
The willingness of a participant to be randomized to a sham or real intervention is very important in clinical trials.
Can spend 12 weeks on the intervention, and more time for pre and post testing.
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Conditions
Cancer Related
Treatments