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

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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?

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
View:

• PD Diagnosis by UK Brain Bank Criteria

• Hoehn \& Yahr stage I-IV in the off-state

• FOG noted in medical history

• FOG confirmed visually by the examiner in the office

• PD that is levodopa-treated and responsive

• Able to manage 12 hours of OFF dopaminergic medication state

• Age 50-80 years

• Able to sign a consent document and willing to participate in all aspects of the study

Locations
United States
Georgia
Emory Movement Disorders Center
RECRUITING
Atlanta
Contact Information
Primary
Barbara Sommerfeld, MSN, RN
bsommer@emory.edu
404-712-6997
Time Frame
Start Date: 2024-07-08
Estimated Completion Date: 2025-12
Participants
Target number of participants: 28
Treatments
Experimental: Flicker Exposure (Treatment Group)
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.
Sham_comparator: Control Group
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.
Related Therapeutic Areas
Sponsors
Collaborators: Parkinson's Foundation
Leads: Emory University

This content was sourced from clinicaltrials.gov