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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help individuals with mild Parkinson's disease manage their symptoms. It uses a device called GENUS, which delivers light, sound, and touch to increase certain brain wave activity that might alleviate symptoms like tremors or slow movement. Participants will receive either the active stimulation or a placebo version to assess the device's safety and effectiveness. Individuals diagnosed with Parkinson's, experiencing symptoms like tremors or rigidity, and maintaining a stable medication dose for at least a month might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance symptom management for Parkinson's patients.

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 prior data suggests that this method is safe for Parkinson's disease patients?

Research has shown that the GENUS device, which uses light and sound therapy at 40Hz, is safe. Studies have found that this therapy is easy to use daily and does not cause serious side effects. For instance, Alzheimer's disease trials reported no serious problems with this type of therapy. While researchers have tested GENUS for other conditions, its effects on Parkinson's disease remain under study. However, current evidence suggests it is generally well-tolerated, making it a promising area for further research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the GENUS device for Parkinson's Disease because it uses gamma wave stimulation, a novel approach that targets brain activity. Unlike standard treatments like levodopa or dopamine agonists, which primarily focus on replenishing dopamine levels, this method involves exposing patients to 40Hz sensory stimulation. This technique aims to modulate brain waves directly, which could offer new ways to manage symptoms and potentially slow disease progression. This non-invasive approach is a significant departure from traditional medication, offering hope for improved quality of life without the side effects associated with long-term drug therapies.

What evidence suggests that the GENUS device is effective for Parkinson's disease?

Research has shown that boosting certain brain waves, called gamma waves (30-80 Hz), may improve brain health and function. Studies have found that using 40 Hz multisensory stimulation, such as the GENUS device, can support brain health and might help with conditions like Alzheimer's. Recent research suggests that this therapy could also benefit movement symptoms in Parkinson's disease. In this trial, participants in the Parkinson's Active Arm will receive active sensory stimulation (40 Hz) using the GENUS device, while those in the Parkinson's Control Arm will receive sham stimulation. Some evidence indicates that gamma wave stimulation can alter brain function, potentially alleviating Parkinson's symptoms like shaking and stiffness. Although this treatment is still under investigation, early findings suggest it could help people with Parkinson's. ^{1 2 4 5 6}

Who Is on the Research Team?

Li-Huei Tsai, PhD

Principal Investigator

Massachusetts Institute of Technology

Diane Chan, MD, PhD

Principal Investigator

Massachusetts Institute of Technology

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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]

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]

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 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]

Citations

1. 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

2. 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 ...

3. molecularneurodegeneration.biomedcentral.com molecularneurodegeneration.biomedcentral.com/articles/10.1186/s13024-024-00785-x

Mystery of gamma wave stimulation in brain disorders Present studies indicate that exposure to γ light stimulation leads to functional reorganization across diverse brain regions and modulates ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7349639/

The Effects of Long-Term 40-Hz Physioacoustic Vibrations ... Recent studies have suggested that vibration therapy may have a positive influence in treating motor symptoms of Parkinson's disease (PD).

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/13872877251388664

Therapeutic potential of 40 Hz flickering light stimulation in ... Gamma oscillations (30–100 Hz), generated by the synchronized firing of neurons, play a crucial role in memory storage and retrieval.

6. neurosciencenews.com neurosciencenews.com/daily-light-sound-memory-alzheimers-29865/

Daily Light and Sound Therapy May Slow Alzheimer's ... Safe and Noninvasive: The GENUS 40Hz light-and-sound therapy was well tolerated and feasible for daily home use. Source: Picower Institute ...