Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06295458
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-01-22
Brief Title:
Gamma Sensory Flicker for Parkinsons Disease Patients With Freezing of Gait
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Gamma Sensory Flicker for Parkinsons Disease Patients With Freezing of Gait
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Flicker w FOG
Brief Summary:
This study aims to answer the question to assess the safety and tolerability of gamma light in Parkinsons disease PD patients with freezing of gait FOG
Parkinsons 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 Parkinsons 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
Parkinsons 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 Parkinsons 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
Detailed Description:
This will be a sham-controlled study with one group receiving the sensory stimulation and the other receiving sham stimulation
Exposure will be provided by wearing a pair of glasses and headphones Both of these will be connected to a device that will provide light and sound during the daily 1-hour session
Gamma light appeared in a previous study to have potential as a non-invasive non-medication approach to reduce amyloid from the brain This study will investigate if the link between amyloid and FOG can be changed and improve FOG
Gamma is a short wavelength of light andor sound between 25-140Hz Previous research suggested that 40Hz can potentially activate cells in the brain to remove amyloid Amyloid is a protein that forms in the spaces between nerve cells in the brain in diseases such as Alzheimers and Parkinsons disease
This study also has two optional parts One option is to undergo two lumbar punctures at the baseline and Month 6 visits The other option is to participate in a one-year extension of the study Blood draws will be used to verify levodopa levels in the blood during both the ON and OFF Parkinsons disease medication states
Optional lumbar punctures will be performed at baseline and 6 months to collect cerebrospinal fluid CSF samples which will be analyzed for change in amyloid levels before and after treatment An electroencephalogram EEG will be utilized at the beginning of the study to evaluate the brains response to the stimulus Cognitive testing will be administered to capture any cognitive changes Questionnaires used will provide any changes to the participants self-evaluation
The duration of the blinded portion is approximately 7 months The optional extension portion will have two in-clinic visits at month 12 and month 18 Participants will be enrolled from the Emory University movement disorder clinic
Exposure will be provided by wearing a pair of glasses and headphones Both of these will be connected to a device that will provide light and sound during the daily 1-hour session
Gamma light appeared in a previous study to have potential as a non-invasive non-medication approach to reduce amyloid from the brain This study will investigate if the link between amyloid and FOG can be changed and improve FOG
Gamma is a short wavelength of light andor sound between 25-140Hz Previous research suggested that 40Hz can potentially activate cells in the brain to remove amyloid Amyloid is a protein that forms in the spaces between nerve cells in the brain in diseases such as Alzheimers and Parkinsons disease
This study also has two optional parts One option is to undergo two lumbar punctures at the baseline and Month 6 visits The other option is to participate in a one-year extension of the study Blood draws will be used to verify levodopa levels in the blood during both the ON and OFF Parkinsons disease medication states
Optional lumbar punctures will be performed at baseline and 6 months to collect cerebrospinal fluid CSF samples which will be analyzed for change in amyloid levels before and after treatment An electroencephalogram EEG will be utilized at the beginning of the study to evaluate the brains response to the stimulus Cognitive testing will be administered to capture any cognitive changes Questionnaires used will provide any changes to the participants self-evaluation
The duration of the blinded portion is approximately 7 months The optional extension portion will have two in-clinic visits at month 12 and month 18 Participants will be enrolled from the Emory University movement disorder clinic
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None