Gamma Sensory Flicker for Parkinson's Disease Patients With Freezing of Gait — Flicker w FOG  

Parkinson Disease Clinical Trial

Official title: Gamma Sensory Flicker for Parkinson's Disease Patients With Freezing of Gait

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

This will be a sham-controlled study with one group receiving the gamma stimulus and the other receiving sham stimulation. Blood draws will be used to verify levodopa levels in the blood during both the ON and OFF Parkinson's disease medication states. Lumbar punctures will be performed at baseline and 6 months to collect cerebrospinal fluid (CSF) samples which will be analyzed for change in amyloid levels before and after treatment. An electroencephalogram (EEG) will be utilized at the beginning of the study to evaluate the brain's response to the stimulus. Cognitive testing will be administered to capture any cognitive changes. Questionnaires used will provide any changes to the participant's self-evaluation. The duration of the blinded portion is approximately 7 months. The extension portion will consist of two in-clinic visits at month 12 and month 18. Participants will be enrolled from the Emory University movement disorder clinic. ;

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Nervous System Diseases
• Parkinson Disease

• NCT number: NCT06295458
• Study type: Interventional
• Source: Emory University
• Contact: Barbara Sommerfeld, MSN, RN
• Phone: 404-712-6997
• Email: bsommer@emory.edu
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Completion date: June 2025