Gamma Sensory Flicker for Parkinson's Disease (Flicker w FOG Trial)

N/A

Recruiting

Led By Stewart Factor, DO

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Summary

"This trial aims to study the safety and effectiveness of special eyewear and earphones that emit visual and auditory stimuli in the gamma range on patients with Parkinson's disease. The goal is to reduce a walking

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from wearing the device or sensory overload due to the gamma flicker stimulus. However, specific side effects will be monitored as part of the safety assessment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants compliant with the study procedures

Number of participants with Adverse events

Secondary study objectives

Change in subjective changes in FOG.

Change in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) scale in participants with PD

Change in the freezing of gait severity in participants with PD.

Other study objectives

Change in the effects of driving gamma on cerebrospinal fluid (CSF) amyloid levels in patients with PD-FOG

Change in the effects of driving gamma on cerebrospinal fluid (CSF) inflammatory markers levels in patients with PD-FOG

Trial Design

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.

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