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

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?

Conditions

• Gait Disorders, Neurologic
• Parkinson Disease

Interventions

DEVICE

David Delight Plus Device

Flicker exposure via a light and sound device-based stimulation-provided sensory stimulation device. The DAVID Delight Plus device consists of light-emitting goggles and sound-emitting headphones that are turned on and off with a repetition rate of 40 Hz connected to a controller operated by the participant or study partner (if the participant elects to have an optional study partner). At the baseline visit, light and sound intensity levels (auditory: 0-80 dBA, visual: 0-1400 lux) will be programmed into each participant's controller based on their unique response to tolerance and EEG entrainment testing which occurred at screening. The participant may not detect gamma-flicker frequency.

OTHER

Sham Therapy

Sham therapy will be provided in the same manner as the flicker light. The difference is that it will be a constant light and sound from the same device instead of the 40hz light treatment and sound.

Sponsors & Collaborators

• Parkinson's Foundation

  collaborator OTHER

• Emory University

  lead OTHER

Principal Investigators

• Stewart Factor, DO · Emory University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-08

Primary Completion

2026-06-30

Completion

2027-06-30

FDA Device

Yes

Countries

• United States

Study Locations