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Behavioural Intervention
Near Infrared Stimulation for Parkinson's Disease
N/A
Recruiting
Led By Adam Woods, Ph.D.
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No evidence of dementia or Mild Cognitive Impairment based on cognitive screening (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)
Able to provide informed consent and perform cognitive and mood measures on a computer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to one-week post intervention (approx week 14)
Awards & highlights
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.
Who is the study for?
This trial is for older adults and those with Parkinson's disease who can commit to a 12-week intervention, have no dementia or cognitive impairment, are on stable medication doses, and can use a computer. Excluded are individuals with major brain abnormalities, unstable conditions, active cancer, significant sensory impairments preventing computer use, recent cognitive training participation or psychiatric disturbances.Check my eligibility
What is being tested?
The study tests the effects of near infrared (NIR) stimulation on cognitive and mood performance in aging adults and those with Parkinson's. Participants will be randomly assigned to receive either real NIR treatment using Medx Console System/Vielight units or sham (placebo) versions of these devices.See study design
What are the potential side effects?
As this trial involves non-invasive NIR stimulation devices rather than drugs or invasive procedures, side effects may be minimal but could include discomfort at the site of application or potential visual disturbances due to light exposure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cognitive function is normal for my age, education, and sex.
Select...
I can understand and agree to the study's terms and use a computer for tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to one-week post-intervention (approx week 14)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to one-week post-intervention (approx week 14)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
ARENA, learning and memory change from baseline to post-testing
Secondary outcome measures
NIH Examiner Executive Composite Score change from baseline to post-testing
NIH Examiner, Cognitive Control Domain score change from baseline to post-testing
NIH Examiner, Verbal Fluency Domain Score change from baseline
+3 moreTrial Design
4Treatment groups
Active Control
Placebo Group
Group I: NIR -ParkinsonActive Control2 Interventions
Participants with Parkinson disease receive the Medx Console System and the Vielight 810 intranasal stand alone unit. These interventions occur during 16 lab sessions (1.5 hours each) during an 12 week period, plus daily 25 minute 'at home' intranasal stimulation interventions, 4 days each week.
Group II: NIR -Older AdultActive Control2 Interventions
Older adult participants receive the Medx Console System and the Vielight 810 intranasal stand alone unit. These interventions occur during 16 lab sessions (1.5 hours each) during an 12 week period, plus daily 25 minute 'at home' intranasal stimulation interventions, 4 days each week.
Group III: No Dose NIR-ParkinsonPlacebo Group2 Interventions
Participants with Parkinson disease receive the sham Medx Console System and the sham Vielight 810 intranasal stand alone unit, since the devices deliver no near infrared light. These sham interventions occur during 16 lab sessions (1.5 hours each) during an 12 week period, plus daily 25 minute 'at home' intranasal stimulation interventions, 4 days each week.
Group IV: No Dose NIR-Older AdultPlacebo Group2 Interventions
Older adult participants receive the sham Medx Console System and the sham Vielight 810 intranasal stand alone unit, since the devices deliver no near infrared light. These sham interventions occur during 16 lab sessions (1.5 hours each) during an 12 week period, plus daily 25 minute 'at home' intranasal stimulation interventions, 4 days each week.
Find a Location
Who is running the clinical trial?
University of FloridaLead Sponsor
1,341 Previous Clinical Trials
715,532 Total Patients Enrolled
28 Trials studying Aging
3,267 Patients Enrolled for Aging
McKnight Brain Research FoundationUNKNOWN
2 Previous Clinical Trials
90 Total Patients Enrolled
1 Trials studying Aging
40 Patients Enrolled for Aging
University of ArizonaOTHER
514 Previous Clinical Trials
148,459 Total Patients Enrolled
5 Trials studying Aging
753 Patients Enrolled for Aging
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not been in a cognitive study or training in the last 3 months.My cognitive function is normal for my age, education, and sex.I can commit 12 weeks to the treatment and extra time for tests before and after.I have been diagnosed with active cancer.My cognitive function is normal for my age, education, and sex.I have memory and naming difficulties for my age.I can understand and agree to the study's terms and use a computer for tests.My medication doses have been stable, except for Alzheimer's drugs which have been stable for 2 months.I can perform daily activities without any issues.I have had a major stroke or have a significant brain condition affecting my thinking.I am currently taking antipsychotics, sedatives, or medications with anticholinergic effects.I have been on the same memory medication for at least two months.At least 8th grade education or equivalent skills in reading.I am open to being assigned randomly to a test or control group in the study.I do not have any uncontrolled conditions like severe liver or kidney disease, or HIV.I haven't used any photo-sensitive medications like steroids or retin-A in the last 15 days.
Research Study Groups:
This trial has the following groups:- Group 1: NIR -Parkinson
- Group 2: No Dose NIR-Parkinson
- Group 3: NIR -Older Adult
- Group 4: No Dose NIR-Older Adult
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Aging Patient Testimony for trial: Trial Name: NCT03551392 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I eligible to join the research for this trial?
"This research is seeking 135 individuals with Parkinson's disease aged 65 to 89. Each potential subject must meet several prerequisites, such as having a stable dose of major medications for 2 months prior, no evidence of dementia or Mild cognitive impairment based on cognitive screening tests, 8th grade education and/or ability to read at the same level, willingness to be randomized into either Sham or Real intervention groups, sufficient time commitment (12 weeks) plus additional times for testing before and after treatment."
Answered by AI
To what extent is participation in this clinical study being seen?
"Affirmative. Clinicaltrials.gov records demonstrate that this research project, which was first posted on June 26th 2019, is still actively searching for patients to join their trial. A total of 135 participants need to be recruited from two distinct sites."
Answered by AI
Is enrollment for this investigation still available?
"The clinical trial is open to participants, as evidenced by its presence on the clinicaltrials.gov website. The initial posting of this study was made June 26th 2019 and it has since been revised September 15th 2022."
Answered by AI
Does this research endeavor include participants above the age of 35?
"This study is recruiting seniors aged 65-89."
Answered by AI
Who else is applying?
What state do they live in?
Florida
What site did they apply to?
University of Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I have been diagnosed with MCI. Looking for help with cognitive functions, i.e. executive function.
PatientReceived 1 prior treatment
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