Ignite Creation Date:
2024-05-06 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05857124
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-12
First Post:
2023-05-10
Brief Title:
A Pilot Study Evaluating the Efficacy of the Vielight Neuro RX Gamma in the Treatment of Post COVID-19 Cognitive Impairment
Sponsor:
Vielight Inc
Organization:
Vielight Inc
Study Overview
Official Title:
A Pilot Study Evaluating the Efficacy of the Vielight Neuro RX Gamma in the Treatment of Post COVID-19 Cognitive Impairment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-05
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:
None
Brief Summary:
Some people who have been infected with the virus that causes COVID-19 can experience long-term effects from their infection known as post COVID-19 conditions PCC or long COVID1 The medical circles often describe it as post-acute sequelae of Covid-19 PASC People with post-COVID conditions can have a wide range of symptoms that can last more than four weeks or even months after infection Sometimes the symptoms can even go away or come back again The Centers for Disease and Prevention CDC listed a constellation of 19 symptoms related to post COVID-19
In research brain fog is prominent among the most reported neurological symptoms which also include numbness tingling headache dizziness blurred vision tinnitus and fatigue that last more than a year post-infection
Vielight Inc has developed a compact and portable device named the Vielight RX Gamma which is suitable for home use The intervention is based on the science of photobiomodulation PBM which utilizes certain light energy to modify cellular functions The fundamental mechanisms of PBM are based on the absorption of photons by the mitochondria to modulate cellular functions The Vielight Neuro RX Gamma delivers light of specific wavelengths 810 nm power and duration to the brainnasal cavity to achieve this The biological process involves numerous interacting mechanisms that modulate bodily functions One result of PBM is the benefits it could offer the post COVID-19 long COVID population The Vielight Neuro RX Gamma emitting NIR might reduce inflammatory markers relevant to COVID-19 and since it pulses at 40 Hz can activate the non-inflammatory M2-genotype microglia to remove markers of Alzheimer disease such as beta-amyloid and possibly tau deposits Using Vielight Neuro RX Gamma the same activation of non-inflammatory markers might occur with post COVID-19 long-COVID patient population as well as the reduction in the brain fog
This trial utilizes a completely remote and virtual design It is a double blind randomized controlled trial that is expected to involve 36 participants who are confirmed to have Post- COVID cognitive impairment Eighteen of the participants will be randomized to the active Vielight RX Gamma protocol and the other eighteen participants will be randomized to the sham Vielight RX Gamma regimen The trial will study patients over 120 days and ask them to track their symptoms in a daily survey
In research brain fog is prominent among the most reported neurological symptoms which also include numbness tingling headache dizziness blurred vision tinnitus and fatigue that last more than a year post-infection
Vielight Inc has developed a compact and portable device named the Vielight RX Gamma which is suitable for home use The intervention is based on the science of photobiomodulation PBM which utilizes certain light energy to modify cellular functions The fundamental mechanisms of PBM are based on the absorption of photons by the mitochondria to modulate cellular functions The Vielight Neuro RX Gamma delivers light of specific wavelengths 810 nm power and duration to the brainnasal cavity to achieve this The biological process involves numerous interacting mechanisms that modulate bodily functions One result of PBM is the benefits it could offer the post COVID-19 long COVID population The Vielight Neuro RX Gamma emitting NIR might reduce inflammatory markers relevant to COVID-19 and since it pulses at 40 Hz can activate the non-inflammatory M2-genotype microglia to remove markers of Alzheimer disease such as beta-amyloid and possibly tau deposits Using Vielight Neuro RX Gamma the same activation of non-inflammatory markers might occur with post COVID-19 long-COVID patient population as well as the reduction in the brain fog
This trial utilizes a completely remote and virtual design It is a double blind randomized controlled trial that is expected to involve 36 participants who are confirmed to have Post- COVID cognitive impairment Eighteen of the participants will be randomized to the active Vielight RX Gamma protocol and the other eighteen participants will be randomized to the sham Vielight RX Gamma regimen The trial will study patients over 120 days and ask them to track their symptoms in a daily survey
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None