Post COVID-19 Cognitive ImpairmentPhase 1NCT05857124
A Study Evaluating the Efficacy of the Vielight Neuro RX Gamma in the Treatment of Post COVID-19 Cognitive Impairment
A Phase 1 study testing Vielight Neuro RX Gamma active device in people with Post COVID-19 Cognitive Impairment, run by Vielight Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post COVID-19 Cognitive Impairment
- What is being tested?
- Vielight Neuro RX Gamma active device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to 16 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Post COVID-19 Cognitive Impairment
- Being tested
- Vielight Neuro RX Gamma active device, Vielight Neuro RX Gamma sham device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vielight Neuro RX Gamma active deviceDevice
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.
Vielight Neuro RX Gamma sham deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active treatment devices | Experimental | Vielight Neuro RX Gamma active device Receives: Device: Vielight Neuro RX Gamma active device |
| Sham devices | Sham comparator | Vielight Neuro RX Gamma sham device Receives: Device: Vielight Neuro RX Gamma sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the combined results of 7 Creyos items: Spatial Planning, Monkey Ladder, Rotations, Feature Match, Paired Associates, Token Search, Polygons.
Measured: from baseline to Day 56
Secondary outcomes (6)
Creyos scores of the 5 remaining tests (i.e. Grammatical Reasoning, Spatial Span, Digit Span, Odd One Out, Double Trouble)
Measured: 0, 14, 28, 56 and 84 days
EQ-5D-5L Quality of Life
Measured: 0, 14, 28, 56 and 84 Days
Fatigue Assessment Scale (FAS)
Measured: 0, 56 and 84 Days
The perceived deficits questionnaire - 20 item version (PDQ-20)
Measured: 0, 56 and 84 days
Compliance and Technical Complications
Measured: 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)
Measured: 0 and 56 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start1 Apr 2023
- Primary completion1 Sep 2024
- Study completion16 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post COVID-19 Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vielight Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857124
- Sponsor's protocol ID
- VL-2023-PostCOVID-Pilot
- Status last verified
- Jun 2025
- First submitted
- 10 May 2023
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Lim L, Hosseinkhah N, Van Buskirk M, Oei K, Berk A, Pushparaj A, Liburd J, Abbaspour Z, Rubine J, Jackson D, Zomorrodi R. Photobiomodulation for cognitive dysfunction (Brain Fog) in post-COVID-19 condition: a randomized double-blind sham-controlled pilot trial. EClinicalMedicine. 2026 Jan 13;92:103730. doi: 10.1016/j.eclinm.2025.103730. eCollection 2026 Feb.
PubMed 41768981
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating the Efficacy of the Vielight Neuro RX Gamma in the Treatment of Post COVID-19 Cognitive Impairment
- ClinicalTrials.gov ID
- NCT05857124
- Acronym / sponsor ID
- VL-2023-PostCOVID-Pilot
- Conditions
- Post COVID-19 Cognitive Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Vielight Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 16 Jan 2025 (actual)
- First posted
- 12 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active treatment devices | Experimental | Device: Vielight Neuro RX Gamma active deviceVielight Neuro RX Gamma active device |
| Sham devices | Sham comparator | Device: Vielight Neuro RX Gamma sham deviceVielight Neuro RX Gamma sham device |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vielight Neuro RX Gamma active deviceThe 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. | Device | Active treatment devices |
| Vielight Neuro RX Gamma sham deviceThe 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. | Device | Sham devices |
Primary outcome
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
6 secondary outcomes
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
EQ-5D-5L Quality of Life
Time frame: 0, 14, 28, 56 and 84 Days
Fatigue Assessment Scale (FAS)
Time frame: 0, 56 and 84 Days
The perceived deficits questionnaire - 20 item version (PDQ-20)
Time frame: 0, 56 and 84 days
Compliance and Technical Complications
Time frame: 0 to Day 56
Modified Symptom Burden Questionnaire
Time frame: 0 and 56 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Derived from this study: PubMed 41768981Lim L, Hosseinkhah N, Van Buskirk M, Oei K, Berk A, Pushparaj A, Liburd J, Abbaspour Z, Rubine J, Jackson D, Zomorrodi R. Photobiomodulation for cognitive dysfunction (Brain Fog) in post-COVID-19 condition: a randomized double-blind sham-controlled pilot trial. EClinicalMedicine. 2026 Jan 13;92:103730. doi: 10.1016/j.eclinm.2025.103730. eCollection 2026 Feb.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vielight Neuro RX Gamma active device in people with Post COVID-19 Cognitive Impairment, run by Vielight Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05857124, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.