24 Participants Needed

Near Infrared Stimulation for Parkinson's Disease

Recruiting at 1 trial location
DB
Adam J Woods, PhD profile photo
Overseen ByAdam J Woods, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications as long as they are stable and you plan to continue them during the study. However, you cannot use antipsychotics, sedatives, or medications with significant anticholinergic properties, and you should not use photo-sensitive medications like steroids or retin-A within 15 days of the study.

Is near-infrared light therapy safe for humans?

Research suggests that near-infrared light therapy is generally safe, as it has been used successfully in animal models without toxic effects, and is considered a safe therapy for conditions like Alzheimer's and Parkinson's disease.12345

How does Near Infrared Stimulation treatment for Parkinson's Disease differ from other treatments?

Near Infrared Stimulation (INS) is unique because it uses light instead of electricity to stimulate nerves, offering more precise targeting without the need for genetic modification. This method reduces the risk of side effects associated with traditional electrical stimulation by focusing the stimulation more accurately on the affected areas.678910

What data supports the effectiveness of the treatment Near Infrared Stimulation for Parkinson's Disease?

Research shows that near-infrared light treatment can improve movement and protect brain cells in animal models of Parkinson's disease. It has been effective in reducing symptoms and preventing cell damage in mice and rats, suggesting it might help people with Parkinson's too.14111213

Who Is on the Research Team?

DB

Dawn Bowers, Ph.D.

Principal Investigator

University of Florida

AW

Adam Woods, Ph.D.

Principal Investigator

University of Florida

GA

Gene Alexander, Ph.D.

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.
See 2 more

Exclusion Criteria

Current or past history of major psychiatric disturbance including schizophrenia, active psychosis, bipolar disorder, current major depressive episode, current alcohol or substance abuse within the past six months
I have not been in a cognitive study or training in the last 3 months.
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
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NIR stimulation through transcranial and intranasal methods, involving 16 lab sessions and daily at-home interventions over 12 weeks

12 weeks
16 lab visits (in-person), daily at-home sessions

Follow-up

Participants are monitored for cognitive and mood changes post-treatment

2 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Near Infrared Stimulation
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: 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 II: 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 Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

McKnight Brain Research Foundation

Collaborator

Trials
3
Recruited
80+

University of Arizona

Collaborator

Trials
545
Recruited
161,000+

Published Research Related to This Trial

Near-infrared (Near-IR) light treatment has been shown to enhance cellular function and promote cell survival in models of Parkinson's disease.
This treatment has demonstrated positive outcomes in both laboratory settings and mouse models, suggesting its potential as a therapeutic intervention for Parkinson's disease.
Harnessing the cell's own ability to repair and prevent neurodegenerative disease.Whelan, H., Desmet, K., Buchmann, E., et al.[2021]
Combining 670nm and 810nm near infrared light (NIr) treatments, either sequentially or concurrently, resulted in greater improvements in locomotor activity and neuroprotection in a mouse model of Parkinson's disease compared to using either wavelength alone.
The study suggests that specific combinations of NIr wavelengths can enhance therapeutic outcomes, indicating potential for optimized NIr therapy in human treatments for neurodegenerative diseases.
The behavioural and neuroprotective outcomes when 670nm and 810nm near infrared light are applied together in MPTP-treated mice.Reinhart, F., Massri, NE., Torres, N., et al.[2022]
Near-infrared light (NIr) treatment significantly reduces behavioral deficits and provides neuroprotection in mice exposed to a parkinsonian insult, regardless of whether it is applied before, during, or after the insult.
The beneficial effects of NIr are both fast-acting and long-lasting, with a broad therapeutic window, as it enhances the survival of dopaminergic cells and reduces damage from the toxic agent MPTP.
Near-infrared light (670 nm) reduces MPTP-induced parkinsonism within a broad therapeutic time window.Reinhart, F., El Massri, N., Johnstone, DM., et al.[2022]

Citations

Harnessing the cell's own ability to repair and prevent neurodegenerative disease. [2021]
The behavioural and neuroprotective outcomes when 670nm and 810nm near infrared light are applied together in MPTP-treated mice. [2022]
Near-infrared light (670 nm) reduces MPTP-induced parkinsonism within a broad therapeutic time window. [2022]
Photobiomodulation Suppresses Alpha-Synuclein-Induced Toxicity in an AAV-Based Rat Genetic Model of Parkinson's Disease. [2018]
Near-infrared light is neuroprotective in a monkey model of Parkinson disease. [2022]
Turning On Lights to Stop Neurodegeneration: The Potential of Near Infrared Light Therapy in Alzheimer's and Parkinson's Disease. [2022]
A Phase 2 Randomized Trial of Asleep versus Awake Subthalamic Nucleus Deep Brain Stimulation for Parkinson's Disease. [2021]
Effects of a higher dose of near-infrared light on clinical signs and neuroprotection in a monkey model of Parkinson's disease. [2022]
Neural stimulation with optical radiation. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Infrared neural stimulation: a new stimulation tool for central nervous system applications. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Spatially specific, closed-loop infrared thalamocortical deep brain stimulation. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Combined optical and electrical stimulation of neural tissue in vivo. [2021]
13.United Statespubmed.ncbi.nlm.nih.gov
Short-wave Infrared Neural Stimulation Drives Graded Sciatic Nerve Activation Across A Continuum of Wavelengths. [2021]
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