Near Infrared Stimulation for Parkinson's Disease

Recruiting at 1 trial location

Overseen By Adam J Woods, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must not be taking: Antipsychotics, Sedatives, Steroids, others

Disqualifiers: Major strokes, Schizophrenia, Active cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 17

Duration: 12 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether near infrared (NIR) light can enhance brain health, mood, and cognitive function in older adults. Participants will receive either real or sham (fake) NIR stimulation both in the lab and at home over a 12-week period. The trial seeks individuals without dementia who can use a computer, are on stable medications, and can commit to the trial schedule. As an unphased trial, this study offers a unique opportunity to contribute to innovative research in brain health.

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.

What prior data suggests that near infrared stimulation is safe for older adults?

Research has shown that near infrared (NIR) therapy is generally safe. Studies on similar treatments, such as transcranial photobiomodulation (PBM), have reported very few side effects, which are usually minor. Most people tolerate NIR therapy well. In animal studies, NIR treatment demonstrated benefits, such as improved movement in models of Parkinson's disease. While the research is promising, individual experiences may vary. Always consult healthcare professionals when considering participation in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about near infrared (NIR) stimulation for Parkinson's disease because it offers a novel approach by using light to potentially improve brain function. Unlike standard treatments that primarily focus on managing symptoms with medications like levodopa or dopamine agonists, NIR stimulation targets the brain directly, using light to enhance cellular health and function. This method is non-invasive and can be administered through simple at-home devices, which could provide a more accessible and convenient option for patients. The unique mechanism of using light to stimulate and potentially protect brain cells makes this treatment an exciting area of study.

What evidence suggests that near infrared stimulation might be an effective treatment for Parkinson's disease?

Research has shown that near infrared (NIR) light might benefit people with Parkinson's disease. In animal studies, NIR treatment improved movement and balance. It also appeared to protect brain cells, which could benefit those with Parkinson's. Other research has found that light therapy can enhance mood and reduce depression in people with Parkinson's. In this trial, participants will be assigned to different groups, with some receiving active NIR treatment and others receiving a sham treatment. Overall, these findings suggest that NIR might improve both movement and mood in people with Parkinson's. ^{1 2 4 5 6}

Who Is on the Research Team?

Dawn Bowers, Ph.D.

Principal Investigator

University of Florida

Adam Woods, Ph.D.

Principal Investigator

University of Florida

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.

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

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

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

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?

Group I: NIR -Older Adult Active Control 2 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 Adult Placebo Group 2 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.

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

Chronic near-infrared light treatment (photobiomodulation) for 28 days significantly reduced dopaminergic neuronal loss and improved motor function in a rat model of Parkinson's disease, suggesting its potential as a protective therapy.

The positive effects of this treatment were sustained for at least 6 weeks after stopping the therapy, indicating a lasting benefit that could be important for managing neurodegenerative disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation Suppresses Alpha-Synuclein-Induced Toxicity in an AAV-Based Rat Genetic Model of Parkinson's Disease. Oueslati, A., Lovisa, B., Perrin, J., et al.[2018]

Infrared neural stimulation (INS) offers a promising alternative to traditional electrical stimulation by providing high spatial resolution for targeting neurons without the need for exogenous fluorophores.

Current research on INS shows potential applications across various types of nerves and in neuroprosthetics, highlighting its versatility and effectiveness in stimulating motor and sensory nerves as well as central nervous system tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neural stimulation with optical radiation. Richter, CP., Matic, AI., Wells, JD., et al.[2021]

Infrared neural stimulation (INS) offers a more precise and targeted approach to deep brain stimulation (DBS) compared to traditional electrical methods, reducing unwanted side effects by limiting the spread of activation to specific neural circuits.

INS has been shown to produce graded responses in thalamocortical circuits, allowing for real-time control and optimization of stimulation patterns, which could enhance the efficacy of treatments for neurological and psychiatric disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spatially specific, closed-loop infrared thalamocortical deep brain stimulation. Coventry, BS., Lawlor, GL., Bagnati, CB., et al.[2023]

Infrared neural stimulation (INS) offers a new way to stimulate nerves without the drawbacks of traditional electrical methods, such as needing direct contact and having poor spatial precision.

By combining low-intensity infrared light with a subthreshold electrical stimulus, the safety margin for nerve stimulation is improved, increasing the threshold ratio from 2:1 to nearly 6:1, which could enhance the effectiveness and safety of this stimulation technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined optical and electrical stimulation of neural tissue in vivo. Duke, AR., Cayce, JM., Malphrus, JD., et al.[2021]

Near infrared (NIr) light therapy (600-1070 nm) shows promise as a safe and effective treatment to halt neuronal death in neurodegenerative diseases like Alzheimer's and Parkinson's.

Previous studies have successfully used NIr therapy to protect tissues from various stressors, suggesting its potential as a neuroprotective or disease-modifying intervention for patients suffering from these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Turning On Lights to Stop Neurodegeneration: The Potential of Near Infrared Light Therapy in Alzheimer's and Parkinson's Disease. Johnstone, DM., Moro, C., Stone, J., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 (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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harnessing the cell's own ability to repair and prevent neurodegenerative disease. Whelan, H., Desmet, K., Buchmann, E., et al.[2021]

In a study involving 15 macaque monkeys with Parkinson's disease, a higher dose of near-infrared light (125J) was found to be safe, showing no toxic effects on midbrain cells, and resulted in an increased number of nigral tyrosine hydroxylase immunoreactive cells compared to the MPTP group.

However, this higher dose did not lead to significant improvements in clinical scores or other key measures of neuroprotection, suggesting that lower doses (25J and 35J) may be more effective for treatment strategies in future clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a higher dose of near-infrared light on clinical signs and neuroprotection in a monkey model of Parkinson's disease. Moro, C., El Massri, N., Darlot, F., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Near-infrared light (NIr) treatment significantly reduced clinical and behavioral impairments in a monkey model of Parkinson's disease, with treated monkeys showing much less severe symptoms compared to those that did not receive NIr.

NIr was found to be non-toxic to brain tissue and provided neuroprotection to dopaminergic cells, suggesting its potential as an effective therapeutic agent for Parkinson's disease in future clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Near-infrared light is neuroprotective in a monkey model of Parkinson disease. Darlot, F., Moro, C., El Massri, N., et al.[2022]

Infrared neural stimulation (INS) offers a safer and more precise alternative to traditional electrical stimulation for modulating brain function, reducing risks like tissue trauma and improving spatial specificity.

INS has been successfully used in both peripheral and central nervous systems to investigate brain connectivity and influence behavior in awake nonhuman primates, highlighting its potential for targeted brain stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infrared neural stimulation: a new stimulation tool for central nervous system applications. Chernov, M., Roe, AW.[2022]

Infrared neural stimulation (INS) effectively stimulates nerves with increased spatial selectivity compared to traditional electrical methods, which could enhance treatments for deep brain and vagus nerve stimulation.

In experiments with rat sciatic nerves, stimulation was most effective at a wavelength of 700 nm, indicating that both the wavelength and power level are crucial for optimizing INS, which could help in designing better stimulation systems for human applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-wave Infrared Neural Stimulation Drives Graded Sciatic Nerve Activation Across A Continuum of Wavelengths. Coventry, BS., Sick, JT., Talavage, TM., et al.[2021]

Asleep deep brain stimulation (DBS) for Parkinson's disease showed a mean motor improvement of 52.3% on the Unified Parkinson's Disease Rating Scale, which is comparable to the 47.0% improvement seen in the awake group, suggesting that asleep DBS is an effective alternative.

The study found no serious complications related to the surgery, with only a subcutaneous hematoma reported, indicating that asleep DBS may be a safe option for patients undergoing this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase 2 Randomized Trial of Asleep versus Awake Subthalamic Nucleus Deep Brain Stimulation for Parkinson's Disease. Engelhardt, J., Caire, F., Damon-Perrière, N., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10819946/

Parkinson's Disease and Photobiomodulation: Potential for ... Pre-clinical experiments have indicated that PBM has the potential to improve the clinical signs of Parkinson's disease and to provide neuroprotection.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4707222/

The Potential of Near Infrared Light Therapy in Alzheimer's ... A number of previous studies have reported clear improvements in motor behavior in animal models of Parkinson's disease following NIr treatment. In MPTP-treated ...

3. apdaparkinson.org apdaparkinson.org/article/light-therapy-for-parkinsons-disease/

light-therapy-for-Parkinson's-disease Results: Bright light led to significant improvement of tremor, United Parkinson Disease Rating Scale (UPDRS) I, II, and IV, and depression as ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2405844024088315

NIR-II light therapy improves cognitive performance in ... Our data indicates that NIR-II illumination improves learning and cognitive impairment as well as coordination and balance abilities in PD rats.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04261569

Clinical Trial for Near Infrared Endoventricular Illumination ... In this pilot study the investigators will evaluate the feasibility and tolerance of surgery and brain illumination thanks to the Ev-NIRT medical device.

6. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-024-01351-8

Devices used for photobiomodulation of the brain—a ... Functional near-infrared spectroscopy (NIRS) studies have shown that PBM can effectively increase cerebral oxygenation, which has a great impact ...