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Behavioural Intervention

Near Infrared Stimulation for Parkinson's Disease

N/A

Recruiting

Led By Dawn Bowers, 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

Must not have

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

Previous major strokes or other known significant brain abnormalities or diseases affecting cognition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to one-week post-intervention (approx week 14)

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.

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.

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 below

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My cognitive function is normal for my age, education, and sex.

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I can understand and agree to the study's terms and use a computer for tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not been in a cognitive study or training in the last 3 months.

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I have had a major stroke or have a significant brain condition affecting my thinking.

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I have been diagnosed with active cancer.

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I do not have any uncontrolled conditions like severe liver or kidney disease, or HIV.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to one-week post intervention (approx week 14) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

ARENA, learning and memory change from baseline to post-testing

Secondary study objectives

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 more

Trial 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.

0 / 6Eligibility criteria met