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

NCT06295458 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: STUDY000069452025P010746
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Freezing of Gait (FOG); Amyloid; Gamma Flicker; Parkinson's disease

Outcome Measures

Primary Outcomes (2)

• Number of participants with Adverse events

  Participants will document the occurrence of any adverse events that occur during the flicker exposure to evaluate the safety and tolerability.

  up to 6 months

• Number of participants compliant with the study procedures

  Compliance will be measured by the number of participants who adhere to the study procedures (at-home usage, monitored by the device, and manual log of daily operation by the participants and their study partners).

  up to 6 months

Secondary Outcomes (3)

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

  Baseline and up to 6 months

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

  Baseline and up to 6 months

• Change in subjective changes in FOG.

  Baseline and 6 months

Other Outcomes (2)

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

  Baseline and 6 months

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

  Baseline and 6 months

Study Arms (2)

Flicker Exposure (Treatment Group)

EXPERIMENTAL

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.

Device: David Delight Plus Device

Control Group

SHAM COMPARATOR

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.

Other: Sham Therapy

Interventions

Sham Therapy OTHER

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.

Also known as: Control Group

Control Group

David Delight Plus Device 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.

Also known as: Flicker Device, Intervention Group

Flicker Exposure (Treatment Group)

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• A diagnosis of atypical Parkinsonism, including vascular Parkinsonism
• Prior treatment with medications that cause Parkinsonism
• Stage V PD -unable to walk independently when OFF
• Absence of levodopa response
• Neurological or orthopedic disorders interfering with gait
• Dementia precluding completing the study protocol, including those meeting criteria for dementia with Lewy bodies
• Major depression based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria
• Any medical problems that would preclude participation, including individuals with a history of migraines, tinnitus, or seizures, because sensory stimuli can potentially exacerbate these conditions.
• Profound sensory loss as determined by the investigator.

Sponsors & Collaborators

• Emory University: lead
• Parkinson's Foundation: collaborator

Study Sites (1)

Emory Movement Disorders Center

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Gait Disorders, Neurologic; Parkinson Disease; Alzheimer Disease

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dementia; Tauopathies; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Stewart Factor, DO

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: March 6, 2024
• Study Start: July 8, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: The Investigators will supply the data as supplementary material with the manuscripts upon publication, anticipated no later than 12 months after the study end date.
• Access Criteria: The Research Team will release the data under a license that allows arbitrary reuse with attribution, such as the MIT license.

Locations

US (1)