28 Participants Needed

Gamma Sensory Flicker for Parkinson's Disease

(Flicker w FOG Trial)

BS
Overseen ByBarbara Sommerfeld, MSN, RN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Emory University
Must be taking: Levodopa
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?

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).Parkinson's disease (PD) patients often experience a complex gait disorder known as Freezing of Gait (FOG). FOG is characterized by brief arrests of stepping when initiating gait, turning, and walking straight and patients describe it as their feet being "glued" to the floor. FOG in Parkinson's disease (PD) is a considerable public health burden worldwide. It is a poorly understood gait symptom that has potentially grave consequences as FOG is intermittent and unpredictable, a leading cause of falls with injury, and results in loss of independence. FOG is generally found to be associated with cognitive decline, particularly executive dysfunction which, in turn, has been associated with higher spinal fluid amyloid (Aβ42) levels in PD.There is data linking amyloid to FOG. A previous study showed that the gamma light helped reduce some amyloid. The research team is studying if gamma light exposure for 1 hour daily is well tolerated. Also, does it have any effect on freezing of gait severity?

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.

Is 40 Hz sensory stimulation safe for humans?

Research shows that 40 Hz sensory stimulation, used in studies for Alzheimer's and Parkinson's diseases, is generally safe for humans. In Alzheimer's patients, it was well tolerated over six months, and in Parkinson's disease models, it showed potential benefits without significant adverse effects.12345

How is the Gamma Sensory Flicker treatment different from other treatments for Parkinson's disease?

Gamma Sensory Flicker is unique because it uses non-invasive light and sound at a specific frequency (40 Hz) to potentially reduce harmful protein buildup in the brain and improve symptoms in Parkinson's disease, unlike traditional treatments that often focus on medication to manage symptoms.12567

What data supports the effectiveness of the Gamma Sensory Flicker treatment for Parkinson's Disease?

Research shows that 40 Hz sensory stimulation, similar to Gamma Sensory Flicker, has been effective in reducing symptoms in Parkinson's disease mice and improving sleep and daily activities in Alzheimer's patients. This suggests potential benefits for Parkinson's patients as well.258910

Who Is on the Research Team?

SF

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
See 5 more

Exclusion Criteria

Dementia precluding completing study protocol including those meeting criteria for dementia with Lewy bodies
I have been diagnosed with major depression.
I do not have migraines, tinnitus, or seizures that could worsen with sensory stimuli.
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 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?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Flicker Exposure (Treatment Group)Experimental Treatment1 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 GroupPlacebo Group1 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.

Find a Clinic Near You

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

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

Citations

Clinical outcome of deep brain stimulation for Parkinson's disease. [2022]
A historical justification for and retrospective analysis of the systematic application of light therapy in Parkinson's disease. [2022]
Non-invasive auditory and visual stimulation attenuates α-Synuclein deposition and improves motor and non-motor symptoms in PD mice. [2023]
Sensory-Evoked 40-Hz Gamma Oscillation Improves Sleep and Daily Living Activities in Alzheimer's Disease Patients. [2021]
Light Modulation of Brain and Development of Relevant Equipment. [2021]
40 Hz Light Flicker Alters Human Brain Electroencephalography Microstates and Complexity Implicated in Brain Diseases. [2021]
Optimal flickering light stimulation for entraining gamma rhythms in older adults. [2022]
Bright light therapy with a head-mounted device for anxiety, depression, sleepiness and fatigue in patients with Parkinson's disease. [2020]
'Gamma' band oscillatory response to chromatic stimuli in volunteers and patients with idiopathic Parkinson's disease. [2021]
Phase-adaptive brain stimulation of striatal D1 medium spiny neurons in dopamine-depleted mice. [2023]
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