Active — Not RecruitingNot Applicable

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

United States24 participantsStarted 2024-07-08

Plain-language 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?

Who can participate

Age range50 Years – 80 Years

SexALL

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Inclusion Criteria: * 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 Exclusion Criteria: * 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.

What they're measuring

Number of participants with Adverse events

Timeframe: up to 6 months

Number of participants compliant with the study procedures

Timeframe: up to 6 months

Trial details

NCT IDNCT06295458

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06