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Photobiomodulation

Vielight Neuro RX Gamma for Long COVID-related Cognitive Impairment

Phase 1
Waitlist Available
Research Sponsored by Vielight Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female age 18-65
Diagnosed with Post COVID cognitive impairment who meets WHO-defined post-COVID-19 condition
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 14, 28, 56 and 84 days
Awards & highlights

Study Summary

This trial is looking at whether a device called the Vielight RX Gamma can help people who have long-term effects from their COVID-19 infection, known as post COVID-19 conditions or long COVID. It is a double blind randomized controlled trial to see if the device can reduce symptoms like brain fog.

Who is the study for?
This trial is for English-speaking adults aged 18-65 who have cognitive issues after COVID-19, confirmed by WHO criteria and an MMSE score of less than 27. It's not for pregnant individuals or those with psychiatric/neurological disorders that could explain their symptoms.Check my eligibility
What is being tested?
The study tests the Vielight Neuro RX Gamma device, which uses light to potentially improve brain function in post-COVID patients. Participants will use either the real device or a sham (fake) one at home and track their symptoms over 120 days.See study design
What are the potential side effects?
Since this intervention involves non-invasive light therapy, side effects are expected to be minimal. However, specific side effect information may not be provided as it depends on individual reactions to photobiomodulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I have been diagnosed with cognitive issues after COVID-19, as per WHO guidelines.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 14, 28, 56 and 84 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 14, 28, 56 and 84 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The change in the combined results of 7 Creyos items: Spatial Planning, Monkey Ladder, Rotations, Feature Match, Paired Associates, Token Search, Polygons.
Secondary outcome measures
Compliance and Technical Complications
Creyos scores of the 5 remaining tests (i.e. Grammatical Reasoning, Spatial Span, Digit Span, Odd One Out, Double Trouble)
EQ-5D-5L Quality of Life
+3 more
Other outcome measures
Exploratory Endpoints

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active treatment devicesExperimental Treatment1 Intervention
Vielight Neuro RX Gamma active device
Group II: Sham devicesPlacebo Group1 Intervention
Vielight Neuro RX Gamma sham device

Find a Location

Who is running the clinical trial?

Vielight Inc.Lead Sponsor
4 Previous Clinical Trials
603 Total Patients Enrolled

Media Library

Vielight Neuro RX Gamma (Photobiomodulation) Clinical Trial Eligibility Overview. Trial Name: NCT05857124 — Phase 1
Cognitive Impairment Research Study Groups: Active treatment devices, Sham devices
Cognitive Impairment Clinical Trial 2023: Vielight Neuro RX Gamma Highlights & Side Effects. Trial Name: NCT05857124 — Phase 1
Vielight Neuro RX Gamma (Photobiomodulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05857124 — Phase 1
~18 spots leftby May 2025
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