Gamma Sensory Flicker for Parkinson's Disease
(Flicker w FOG Trial)
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?
What data supports the effectiveness of the Gamma Sensory Flicker treatment for Parkinson's Disease?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive gamma light exposure for 1 hour daily to assess safety and tolerability
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into a one-year extension of the study with additional visits at month 12 and month 18
What Are the Treatments Tested in This Trial?
Interventions
- GammaSense Stimulation System
Find a Clinic Near You
Who Is Running the Clinical Trial?
Emory University
Lead Sponsor
Parkinson's Foundation
Collaborator