Gamma Sensory Flicker for Parkinson's Disease

(Flicker w FOG Trial)

Overseen By Barbara Sommerfeld, MSN, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Must be taking: Levodopa

Disqualifiers: Atypical parkinsonism, Dementia, Major depression, others

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

Compensation: Varies

Number of Visits: 4

Duration: 7 months

28 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether daily exposure to gamma light can help people with Parkinson's disease who experience freezing of gait, a symptom where their feet feel stuck to the floor while moving. The researchers aim to determine if the GammaSense Stimulation System is safe and can reduce the severity of these episodes. Participants will receive either real light exposure or a sham (placebo) setup to compare effects. Those with Parkinson's disease, who experience freezing of gait, and are currently treated with levodopa might be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new treatment options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires participants to manage 12 hours without dopaminergic medication. This suggests you may need to adjust your medication schedule during the study.

What prior data suggests that the GammaSense Stimulation System is safe for Parkinson's disease patients with freezing of gait?

Research has shown that 40 Hz sensory stimulation is generally safe for people. Studies have used this type of stimulation with patients who have Alzheimer's and Parkinson's. Most participants tolerated the treatment well, experiencing few issues.

For Parkinson's patients, researchers focus on using gamma light to assess its impact on the severity of freezing of gait (FOG). So far, the treatment has been mostly free of serious side effects. Some participants might feel sleepy or tired, but these effects are usually mild.

The GammaSense Stimulation System uses light at a specific frequency (40 Hz) to support brain function. It has been studied for years, and early findings suggest it may enhance brain health without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Gamma Sensory Flicker treatment for Parkinson's Disease because it offers a novel approach that differs from standard options like medications (e.g., Levodopa) or deep brain stimulation. Unlike these treatments, which primarily focus on managing symptoms, the GammaSense Stimulation System uses visual flicker to potentially influence brain activity at a fundamental level. This technique aims to modulate neural oscillations, offering a non-invasive and potentially more natural way to tackle the disease's progression. By exploring this innovative method, researchers hope to uncover new pathways for improving patient outcomes.

What evidence suggests that the GammaSense Stimulation System is effective for freezing of gait in Parkinson's disease?

Research has shown that a type of light therapy called gamma sensory flicker can help reduce a protein linked to memory and thinking problems in Parkinson's disease. In this trial, participants in the Flicker Exposure (Treatment Group) will use the GammaSense Stimulation System, which studies have shown reduces medication needs and side effects. Additionally, using 40 Hz gamma light has demonstrated positive effects on brain function and behavior in animal studies. Another study suggested that increasing gamma rhythms might improve brain health in diseases like Alzheimer's. These findings support the potential of gamma light therapy to assist with walking difficulties in Parkinson's patients. ^{1 3 4 5 6}

Who Is on the Research Team?

Stewart Factor, DO

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for Parkinson's disease patients who experience freezing of gait (FOG), a condition where they feel their feet are 'glued' to the floor. Participants should have cognitive function good enough to follow study procedures and provide consent.

Inclusion Criteria

My Parkinson's responds to levodopa treatment.

I can go 12 hours without my Parkinson's medication.

PD Diagnosis by UK Brain Bank Criteria

Exclusion Criteria

Dementia precluding completing study protocol including those meeting criteria for dementia with Lewy bodies

Profound sensory loss as determined by the investigator

I have been diagnosed with major depression.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive gamma light exposure for 1 hour daily to assess safety and tolerability

7 months

Monthly check-ins every 2 weeks (virtual or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into a one-year extension of the study with additional visits at month 12 and month 18

12 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• GammaSense Stimulation System

Trial Overview The study tests special eyewear and earphones that emit gamma flicker stimuli, used for one hour daily. It aims to see if this non-drug approach can reduce FOG by affecting amyloid levels in spinal fluid, which are high in such patients.

How Is the Trial Designed?

Group I: Flicker Exposure (Treatment Group) Experimental Treatment 1 Intervention

Participants will be instructed to take home the stimulation equipment. Participants and their study partners (if applicable) will be trained on how to use the device before leaving the facility. Each device case also includes an instruction document. Participants and/or study partners (if applicable) will keep a manual log of daily operation, including the time of day used, whether the participant felt drowsy or, was able to complete the entire session, or if the participant was unable to complete the therapy that day. Finally, study staff will contact participants monthly every 2 weeks to ensure compliance, assess adverse events, and log concomitant medications.

Group II: Control Group Placebo Group 1 Intervention

Participants will receive sham stimulation. Participants and/or study partners (if applicable) will keep a manual log of daily operation, including the time of day used, whether the participant felt drowsy or, was able to complete the entire session, or if the participant was unable to complete the therapy that day. Finally, study staff will contact participants monthly every 2 weeks to ensure compliance, assess adverse events, and log concomitant medications.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Parkinson's Foundation

Collaborator

Trials

13

Recruited

1,030,000+

Published Research Related to This Trial

Chronic exposure to 40 Hz auditory and visual stimulation significantly reduced α-synuclein deposition in neurons of the motor cortex in Parkinson's disease mice, suggesting a potential method to modify disease pathology.

The 40 Hz stimulation improved neuromuscular strength, spatial working memory, and reduced depressive-like behaviors in Parkinson's disease mice, indicating its therapeutic potential for addressing both motor and non-motor symptoms of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive auditory and visual stimulation attenuates α-Synuclein deposition and improves motor and non-motor symptoms in PD mice. Liu, Y., Liu, H., Lu, Y., et al.[2023]

In a study comparing visual responses in normal volunteers and patients with mild to moderate Parkinson's disease, it was found that patients had longer latencies in their visual evoked potentials (VEPs) to achromatic and red-green stimuli, indicating potential processing delays in visual information.

The research suggests that gamma activity in response to visual stimuli originates in the cortex and may be modulated by dopamine, highlighting differences in visual processing between healthy individuals and those with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Gamma' band oscillatory response to chromatic stimuli in volunteers and patients with idiopathic Parkinson's disease. Sannita, WG., Carozzo, S., Orsini, P., et al.[2021]

Deep brain stimulation (DBS), particularly targeting the subthalamic nucleus, is highly effective for treating advanced Parkinson's disease, improving both motor and nonmotor symptoms significantly more than medication alone, with benefits lasting up to 10 years.

Quality of life (QoL) improvements are substantial with DBS, and recent studies suggest that even patients with early-stage symptoms experience significant benefits, indicating that neurostimulation may be advantageous even before advanced disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcome of deep brain stimulation for Parkinson's disease. Deuschl, G., Paschen, S., Witt, K.[2022]

The study demonstrated that 40 Hz light flicker significantly enhances brain activity in healthy individuals, particularly in the visual cortex, as measured by EEG, suggesting its potential for therapeutic use in brain diseases.

Changes in microstate metrics associated with 40 Hz light flicker indicate its ability to influence brain function, which could be relevant for conditions like Alzheimer's disease and stroke, paving the way for future clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

40 Hz Light Flicker Alters Human Brain Electroencephalography Microstates and Complexity Implicated in Brain Diseases. Zhang, Y., Zhang, Z., Luo, L., et al.[2021]

In a study of 35 cognitively normal older adults, flickering light stimulation (FLS) at 700 cd/m2 and frequencies of 32 Hz or 34 Hz produced stronger gamma rhythm entrainment compared to lower luminance and higher frequencies, indicating optimal parameters for brain stimulation.

The study found that the gamma rhythm entrainment was effective regardless of whether white or red light was used, and adverse effects were similar across different FLS parameters, suggesting safety in using these stimulation settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal flickering light stimulation for entraining gamma rhythms in older adults. Park, Y., Lee, K., Park, J., et al.[2022]

In a study involving 16 patients with Parkinson's disease, daily bright light therapy (BLT) did not show significant improvements in overall anxiety, depression, or fatigue compared to placebo.

However, patients with higher baseline daytime sleepiness scores experienced a significant reduction in sleepiness after BLT, suggesting that this therapy may be beneficial for specific subgroups of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bright light therapy with a head-mounted device for anxiety, depression, sleepiness and fatigue in patients with Parkinson's disease. Raymackers, JM., Andrade, M., Baey, E., et al.[2020]

A 6-month study involving 22 patients with mild to moderate Alzheimer's disease showed that daily 40 Hz gamma sensory stimulation therapy was well tolerated and helped maintain functional abilities, unlike the sham group which experienced a decline.

Patients receiving the active treatment had improved sleep quality, as indicated by reduced nighttime activity, suggesting that gamma sensory stimulation may have beneficial effects on both sleep and cognitive function in Alzheimer's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensory-Evoked 40-Hz Gamma Oscillation Improves Sleep and Daily Living Activities in Alzheimer's Disease Patients. Cimenser, A., Hempel, E., Travers, T., et al.[2021]

A new phase-adaptive, real-time algorithm for optogenetic stimulation was developed, allowing for precise stimulation of brain rhythms in dopamine-depleted mice, with a latency of just 13 milliseconds.

Both 4 Hz and 20 Hz stimulation improved movement speed in the mice, with the 4 Hz stimulation showing unique phase-dependent effects, highlighting the importance of phase in brain stimulation for potential treatments of conditions like Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase-adaptive brain stimulation of striatal D1 medium spiny neurons in dopamine-depleted mice. Kim, Y., Jung, D., Oya, M., et al.[2023]

A retrospective study involving 129 Parkinson's disease patients indicated that light therapy, when combined with controlled dopamine replacement therapy, can lead to significant improvements in motor and non-motor symptoms, especially in patients who adhered to the treatment regimen.

Patients who consistently followed the light therapy showed better outcomes and a reduced need for medication, resulting in fewer side effects compared to those who were less compliant or discontinued treatment, suggesting that light therapy may help slow the progression of Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A historical justification for and retrospective analysis of the systematic application of light therapy in Parkinson's disease. Willis, GL., Moore, C., Armstrong, SM.[2022]

Optogenetic techniques allow for precise activation or silencing of specific neurons, which is crucial for studying brain disorders like Alzheimer's, Parkinson's, and depression in animal models.

Photobiomodulation (PBM) is a safe light therapy that enhances brain activity without causing damage, and it has shown promise in improving brain function in humans with these disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Light Modulation of Brain and Development of Relevant Equipment. Li, X., Liu, C., Wang, R.[2021]

Citations

1. withpower.com withpower.com/trial/phase-parkinson-disease-2-2024-70f08

Gamma Sensory Flicker for Parkinson's Disease Patients who consistently followed the light therapy showed better outcomes and a reduced need for medication, resulting in fewer side effects compared to those ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0014488623000808

Non-invasive auditory and visual stimulation attenuates α- ... Collectively, we demonstrated that chronic multisensory gamma stimulation (40 Hz and 80 Hz) significantly attenuates α-Syn deposition in neurons of the ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11952037/

40 Hz multisensory stimulation therapy for cognitive impairment This study explores the impact of a 40 Hz multisensory stimulation treatment on brain function, behavior, and disease progression in animal models

4. news.mit.edu news.mit.edu/2025/evidence-40hz-gamma-stimulation-promotes-brain-health-expanding-0314

Evidence that 40Hz gamma stimulation promotes brain ... A decade of studies provide a growing evidence base that increasing the power of the brain's gamma rhythms could help fight Alzheimer's, and perhaps other ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10149720/

Gamma sensory entrainment for cognitive improvement in ... As such, decreased gamma oscillation has been associated with cognitive declines in neurological diseases, such as memory dysfunction in ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06295458/gamma-sensory-flicker-for-parkinsons-disease-patients-with-freezing-of-gait

Gamma Sensory Flicker for Parkinson's Disease Patients ... This study aims to answer the question: to assess the safety, and tolerability of gamma light in Parkinson's disease (PD) patients with freezing of gait (FOG).