A Pilot Study Evaluating the Efficacy of the Vielight Neuro RX Gamma in the Treatment of Post COVID-19 Cognitive Impairment

Study Overview
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Brief Summary
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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 brain/nasal 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.

Official Title
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A Pilot Study Evaluating the Efficacy of the Vielight Neuro RX Gamma in the Treatment of Post COVID-19 Cognitive Impairment

Conditions
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Post COVID-19 Cognitive Impairment

Intervention / Treatment
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* Device: Vielight Neuro RX Gamma active device
* Device: Vielight Neuro RX Gamma sham device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female age 18-65. Diagnosed with Post COVID cognitive impairment who meets WHO-defined post-COVID-19 condition Mini Mental State Examination (MMSE) score of <27 Capable of filling out an online patient diary in English. Exclusion Criteria: Current symptoms are explained by a psychiatric or neurological disorder Having or history of any major neurological or psychiatric illness Pregnant Physical, cognitive, or language impairments sufficient to adversely affect data derived from cognitive assessments or History of mild traumatic brain injury (TBI)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active treatment devices<br>Vielight Neuro RX Gamma active device | Device: Vielight Neuro RX Gamma active device<br>* The Vielight Neuro RX Gamma active device is a home-use photobiomodulation (PBM) device designed to deliver near-infrared (810 nm) light (or photons) to the brain/scalp and nasal tissues.<br>|
| Sham Comparator: Sham devices<br>Vielight Neuro RX Gamma sham device | Device: Vielight Neuro RX Gamma sham device<br>* The Vielight Neuro RX Gamma sham device is a home-use device similar to the Vielight Neuro RX Gamma active device, but acting as a sham.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in the combined results of 7 Creyos items: Spatial Planning, Monkey Ladder, Rotations, Feature Match, Paired Associates, Token Search, Polygons. |  | from baseline to Day 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creyos scores of the 5 remaining tests (i.e. Grammatical Reasoning, Spatial Span, Digit Span, Odd One Out, Double Trouble) |  | 0, 14, 28, 56 and 84 days | 
| EQ-5D-5L Quality of Life |  | 0, 14, 28, 56 and 84 Days | 
| Fatigue Assessment Scale (FAS) |  | 0, 56 and 84 Days | 
| The perceived deficits questionnaire - 20 item version (PDQ-20) |  | 0, 56 and 84 days | 
| Compliance and Technical Complications |  | 0 to Day 56 | 
| Modified Symptom Burden Questionnaire | (Breathing Pain Fatigue Memory, Thinking and Communication Sleep Ears, Nose and Throat Stomach and Digestion Other Symptoms) | 0 and 56 Days |