Gamma Wave Stimulation for Parkinson's Disease

Overseen By Remi Philips, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts Institute of Technology

Must be taking: Antiparkinsonian agents

Must not be taking: Sedatives

Disqualifiers: Atypical Parkinson's, Dementia, Epilepsy, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

No, you will not have to stop taking your current medications. Participants must be on a stable dose of their Parkinson's medications for at least one month before the study and remain on that dose during the study.

What data supports the effectiveness of the Gamma Wave Stimulation treatment for Parkinson's Disease?

Research shows that 40 Hz light and sound therapy can reduce harmful protein deposits in the brain and improve movement, memory, and mood in mice with Parkinson's-like symptoms. Additionally, light therapy has been found to ease movement issues and depression in people with Parkinson's, suggesting it could be a helpful non-drug treatment. ^{1 2 3 4 5}

Is gamma wave stimulation safe for humans?

There is no specific safety data available for gamma wave stimulation under the names provided, but deep brain stimulation (DBS), a similar treatment, is generally considered safe with low risks of complications like infection and device issues, especially in experienced centers. ^{6 7 8 9 10}

How is the GENUS device treatment different from other treatments for Parkinson's disease?

The GENUS device uses 40 Hz light and sound therapy to stimulate brain activity, which is a non-invasive approach that may reduce harmful protein deposits and improve motor and mood symptoms in Parkinson's disease, unlike traditional drug treatments or invasive procedures like deep brain stimulation. ^{1 4 8 11 12}

What is the purpose of this trial?

Parkinson's disease (PD) impacts different types of neural oscillations in the brain, including beta (13-30Hz) and gamma oscillations (30-80Hz), which contributes to PD's cardinal symptoms of resting tremor, rigidity, bradykinesia (slowness of movement), and gait instability. The investigators' lab has developed a non-invasive method of increasing gamma power in the brain using Gamma Entrainment Using Sensory Stimulation (GENUS) through light, sound, and tactile stimulation devices. For this study, 40 participants with mild Parkinson's disease will be recruited, and the investigators will assess their brain waves with electroencephalogram (EEG) before, during, and after light, sound, and tactile stimulation to determine the safety, feasibility, and optimization of GENUS as a potential therapy in the PD population.

Research Team

Diane Chan, MD, PhD

Principal Investigator

Massachusetts Institute of Technology

Li-Huei Tsai, PhD

Principal Investigator

Massachusetts Institute of Technology

Eligibility Criteria

This trial is for people aged 45-90 with mild Parkinson's disease, who are at Hoehn & Yahr stage 2 to 3. Participants must be stable on their current Parkinson's medications and have a MOCA score ≥26. They should not have any other neurological conditions or recent changes in medication, and cannot be pregnant or have had seizures recently.

Inclusion Criteria

I am able to understand and sign the consent form.

Subject has a Montreal Cognitive Assessment (MOCA) score ≥26

I have been diagnosed with Parkinson's disease by a specialist.

Exclusion Criteria

Pregnant

Recent drug or alcohol abuse or dependence

Laboratory results that would pose safety risk

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either active 40Hz sensory stimulation or control stimulation for 30-60 minutes

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including cognitive and mental health evaluations

Immediately after treatment

1 visit (in-person)

Treatment Details

Interventions

• GENUS device

Trial Overview The GENUS device is being tested to see if it can improve motor and cognitive deficits in Parkinson's by using light, sound, and tactile stimulation. The study will involve EEG monitoring of brain waves before, during, and after the use of the device to assess its safety and effectiveness.

Participant Groups

Group I: Parkinson's Active Arm Experimental Treatment 1 Intervention

Exposure to active sensory stimulation (40Hz) for 30-60 minutes.

Group II: Parkinson's Control Arm Placebo Group 1 Intervention

Exposure to control stimulation (sham) for 30-60 minutes.

GENUS device is already approved in United States for the following indications:

Approved in United States as 40Hz Light and Sound Therapy for:

• Alzheimer's disease

Who Is Running the Clinical Trial?

Massachusetts Institute of Technology

Lead Sponsor

Trials

104

Recruited

12,810,000+

Findings from Research

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]

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]

This clinical trial is investigating the safety and efficacy of a novel transcranial LED helmet device called 'PDNeuro' for treating symptoms of Parkinson's disease in 40 participants over 24 weeks, using a randomized placebo-controlled design.

The study aims to assess improvements in mobility, fine motor skills, and cognition, with results expected to inform future larger trials on the effectiveness of photobiomodulation therapy in Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for randomized controlled trial to evaluate the safety and feasibility of a novel helmet to deliver transcranial light emitting diodes photobiomodulation therapy to patients with Parkinson's disease. McGee, C., Liebert, A., Herkes, G., et al.[2022]

Artificial light therapy (LT) significantly reduced symptoms of rigidity and bradykinesia in 40 patients with idiopathic parkinsonism, while also improving motor functions and decreasing depression severity after 10 sessions.

LT was safe, easy to administer, and allowed patients to better tolerate drug holidays, suggesting it could be an effective non-drug treatment option, especially for those with early-stage parkinsonism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The phototherapy of parkinsonism patients]. Artemenko, AR., Levin, IaI.[2022]

Light therapy shows promise in improving both motor and non-motor symptoms in patients with Parkinson's disease, indicating its potential as a novel treatment option.

Further research is needed to develop mechanism-based protocols for light therapy, which could enhance its effectiveness and safety in treating Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Light Therapy in Parkinson's Disease: Towards Mechanism-Based Protocols. Fifel, K., Videnovic, A.[2019]

A review of 221 unique adverse events related to deep brain stimulation (DBS) devices for Parkinson's disease revealed that the most common complications were infections (16.2%) and lead migrations (8.6%).

Over 40% of the reported adverse events required patients to return to the operating room for device explantation or revision, highlighting the need for further research to improve the safety and reliability of DBS systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing Complications of Deep Brain Stimulation Devices for the Treatment of Parkinsonian Symptoms Without Tremor: A Federal MAUDE Database Analysis. Bennett, J., MacGuire, J., Novakovic, E., et al.[2023]

In a study assessing MRI-related heating for the Activa Tremor Control System used in deep brain stimulation, significant temperature increases were observed, ranging from 2.5 to 25.3 degrees Celsius with body RF coils, indicating potential safety concerns under certain conditions.

However, when using clinically relevant positioning techniques and lower specific absorption rates (SARs) for brain imaging, the heating effects were minimal, suggesting that the neurostimulation system can be safely used during MRI under controlled conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurostimulation systems for deep brain stimulation: in vitro evaluation of magnetic resonance imaging-related heating at 1.5 tesla. Rezai, AR., Finelli, D., Nyenhuis, JA., et al.[2019]

Deep brain stimulation (DBS) is a reversible and adjustable treatment for movement disorders like essential tremor and Parkinson's disease, with a low complication risk of ≤ 5% at experienced centers.

Future advancements in DBS technology include directional brain electrodes and 'closed loop' systems that can adapt stimulation based on real-time brain activity, potentially improving treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for movement disorders. Larson, PS.[2021]

In a study of 11 Parkinson's disease patients, levodopa treatment significantly enhanced gamma frequency band reactivity in the subthalamic nucleus (STN) contralateral to movement, indicating a restoration of more physiological movement patterns.

While levodopa did not cause lateralization in power suppression at lower frequencies, it did increase the overall degree of power suppression, suggesting that dopaminergic therapy improves movement-related reactivity in the STN.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dopaminergic therapy promotes lateralized motor activity in the subthalamic area in Parkinson's disease. Androulidakis, AG., Kühn, AA., Chen, CC., et al.[2022]

Deep brain stimulation (DBS) for Parkinson's disease, particularly targeting the subthalamic nucleus (STN), provides significant motor improvement and allows for reduced medication doses, making it a preferred option for younger patients with motor complications.

While STN DBS has advantages like better motor control and lower current consumption, it requires more intensive postoperative management and carries risks such as infection and hematoma, though the overall benefit-to-risk ratio is considered favorable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment results: Parkinson's disease. Pollak, P., Fraix, V., Krack, P., et al.[2019]

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]

In a study with 20 healthy participants, 40 Hz gamma-frequency violet light (VL) stimulation was found to induce unique changes in EEG activity, particularly increasing alpha-gamma coupling, which may enhance visual processing.

Compared to white light (WL), 40 Hz-VL resulted in lower enhancements in delta and theta bands, suggesting that VL may have a different neuromodulatory effect on brain activity than WL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiological Neuromodulation of Resting-State EEG and Steady-State Visual-Evoked Potentials by 40 Hz Violet Light Optical Stimulation in Healthy Individuals. Noda, Y., Takano, M., Hayano, M., et al.[2021]

References

1. United States 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Harnessing the cell's own ability to repair and prevent neurodegenerative disease. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Protocol for randomized controlled trial to evaluate the safety and feasibility of a novel helmet to deliver transcranial light emitting diodes photobiomodulation therapy to patients with Parkinson's disease. [2022]

4. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The phototherapy of parkinsonism patients]. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Light Therapy in Parkinson's Disease: Towards Mechanism-Based Protocols. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Characterizing Complications of Deep Brain Stimulation Devices for the Treatment of Parkinsonian Symptoms Without Tremor: A Federal MAUDE Database Analysis. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Neurostimulation systems for deep brain stimulation: in vitro evaluation of magnetic resonance imaging-related heating at 1.5 tesla. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for movement disorders. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Dopaminergic therapy promotes lateralized motor activity in the subthalamic area in Parkinson's disease. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Treatment results: Parkinson's disease. [2019]

11. England pubmed.ncbi.nlm.nih.gov

'Gamma' band oscillatory response to chromatic stimuli in volunteers and patients with idiopathic Parkinson's disease. [2021]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Photobiological Neuromodulation of Resting-State EEG and Steady-State Visual-Evoked Potentials by 40 Hz Violet Light Optical Stimulation in Healthy Individuals. [2021]