- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05857124
A Pilot Study Evaluating the Efficacy of the Vielight Neuro RX Gamma in the Treatment of Post COVID-19 Cognitive Impairment
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
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California
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Fullerton, California, United States, 92835
- Ascada Research
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Contact:
- Kevin Oei, Dr.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active treatment devices
Vielight Neuro RX Gamma active device
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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.
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Sham Comparator: Sham devices
Vielight Neuro RX Gamma sham device
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The change in the combined results of 7 Creyos items: Spatial Planning, Monkey Ladder, Rotations, Feature Match, Paired Associates, Token Search, Polygons.
Time Frame: from baseline to Day 56
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from baseline to Day 56
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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)
Time Frame: 0, 14, 28, 56 and 84 days
|
0, 14, 28, 56 and 84 days
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EQ-5D-5L Quality of Life
Time Frame: 0, 14, 28, 56 and 84 Days
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0, 14, 28, 56 and 84 Days
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Fatigue Assessment Scale (FAS)
Time Frame: 0, 56 and 84 Days
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0, 56 and 84 Days
|
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The perceived deficits questionnaire - 20 item version (PDQ-20)
Time Frame: 0, 56 and 84 days
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0, 56 and 84 days
|
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Compliance and Technical Complications
Time Frame: 0 to Day 56
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0 to Day 56
|
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Modified Symptom Burden Questionnaire
Time Frame: 0 and 56 Days
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(Breathing Pain Fatigue Memory, Thinking and Communication Sleep Ears, Nose and Throat Stomach and Digestion Other Symptoms)
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0 and 56 Days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exploratory Endpoints
Time Frame: 0 to Day 56
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Statistical analysis of the Creyos changes between treatment groups may warrant further exploration of the primary endpoint model
|
0 to Day 56
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Neurocognitive Disorders
- Cognition Disorders
- COVID-19
- Cognitive Dysfunction
Other Study ID Numbers
- VL-2023-PostCOVID-Pilot
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Post COVID-19 Cognitive Impairment
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University of PennsylvaniaNational Institutes of Health (NIH); Medical College of WisconsinEnrolling by invitationCognitive Impairment | Dyspnea | Long COVID | Long Covid19 | Post-Acute COVID-19 | Post-Acute COVID-19 Infection | Post-Acute COVID-19 Syndrome | OrthostasisUnited States
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Clinical Trials on Vielight Neuro RX Gamma active device
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