protocolSection identificationModule nctId: NCT06295458, orgStudyIdInfo id: STUDY00006945, briefTitle: Gamma Sensory Flicker for Parkinson's Disease Patients With Freezing of Gait, acronym: Flicker w FOG, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Emory University, class: OTHER, collaborators name: Parkinson's Foundation, descriptionModule briefSummary: The purpose of the study is to examine the safety of special eyewear and earphones that emit a visual and auditory stimulus in the gamma range (gamma flicker) in patients with Parkinson's disease for 1 hour per day and to assess the effects this stimulus has on reducing a walking problem referred to as freezing of gait (FOG) as well as on a specific spinal fluid chemical marker, amyloid.Based on previous animal studies this gamma stimulus has the potential as a novel, non-invasive, non-pharmacological approach, to remove amyloid from the brain. The investigators have found in a prior study, that amyloid levels are high in the spinal fluid of Parkinson's patients with 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 in nature, 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., conditionsModule conditions: Gait Disorders, Neurologic, conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: GammaSense Stimulation System, interventions name: Control Group, outcomesModule primaryOutcomes measure: Number of participants with Adverse events, primaryOutcomes measure: Number of participants compliant with the study procedures, secondaryOutcomes measure: Change in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) scale in participants with PD, secondaryOutcomes measure: Change in the freezing of gait severity in participants with PD., secondaryOutcomes measure: Change in subjective changes in FOG., otherOutcomes measure: Change in the effects of driving gamma on cerebrospinal fluid (CSF) amyloid levels in patients with PD-FOG, otherOutcomes measure: Change in the effects of driving gamma on cerebrospinal fluid (CSF) inflammatory markers levels in patients with PD-FOG, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Emory Movement Disorders Center, city: Atlanta, state: Georgia, zip: 30329, country: United States, geoPoint lat: 33.749, lon: -84.38798, hasResults: False