Gamma Sensory Flicker for Parkinson's Disease Patients With Freezing of Gait (NCT06295458) | Clinical Trial Compass
CompletedNot 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 range
50 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used 'gamma sensory flicker' — a type of light and sound stimulation — to try to help with freezing of gait in Parkinson's; can you explain how that approach is thought to work, and whether there's any evidence from this completed study that it actually helped?
2Since the trial is already completed and was mainly measuring safety and whether patients could stick with the procedures, does that mean we still don't have strong proof it's effective, and should I be cautious about reading too much into early results?
3The trial focused specifically on freezing of gait — which is something I struggle with — so would my particular pattern of symptoms make me a reasonable candidate to discuss this kind of treatment with you, or are there standard options we should try first?
4Because this was listed as Phase NA, which often means it's a feasibility or device study rather than a traditional drug trial, what does that mean for how much we can trust the safety and benefit data that came out of it?
5Now that this trial is completed, do you know if the results have been published anywhere, or if there are follow-up studies planned that I could potentially be considered for?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with Adverse events
Timeframe: up to 6 months
2
Number of participants compliant with the study procedures