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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0, 14, 28, 56 and 84 days

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

0 / 2Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to participate in this clinical experiment?

"To be eligible for this research, an individual must demonstrate signs of cognitive impairment and fall within the age range of 18-65 years old. The study is still recruiting - currently aiming to secure 36 qualified participants."

Answered by AI

Are there any vacancies for this research endeavor?

"As outlined on clinicaltrials.gov, this investigation is no longer seeking participants as of May 10th 2023; however there are still 1389 other trials that require additional patients at the current time. This trial was first posted to the site on May 1st 2023."

Answered by AI

Does the age criterion for this medical trial extend beyond thirty years of age?

"This research seeks participants of legal age and below 65 years of maturity."

Answered by AI

To what degree do Active treatment devices pose a hazard to individuals?

"As this is a Phase 1 trial and there are limited clinical data around safety and efficacy, the team at Power assigned an assessment score of 1 to active treatment devices."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Pilot Study Evaluating the Efficacy of the Vielight Neuro RX Gamma in the Treatment of Post COVID-19 Cognitive Impairment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05857124.