NIR -Parkinson for Parkinson's Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Parkinson's Disease+1 MoreMedx Console System - Device
Eligibility
65 - 89
All Sexes
What conditions do you have?
Select

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

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

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.