Toronto, Canada, July 26, 2023 (GLOBE NEWSWIRE) -- Vielight Inc. announced it has commenced a new clinical trial in the United States to study how brain stimulation photobiomodulation (PBM) technology could mitigate long-term cognitive impairment symptoms experienced by patients following a COVID-19 infection. This follows the Health Canada approval for the Vielight RX Plus to treat acute COVID-19 on May 1, 2023. Further information on this approval can be found here.
The study intervention involves a combination of light emitting diodes (LEDs) placed inside the nasal cavity and on the head delivering near infrared (NIR) light to the brain. Vielight has developed a compact home-use device named the “Vielight Neuro RX Gamma” for this purpose. The intervention is based on the science of photobiomodulation (PBM) which uses certain light energy to modify cellular functions.
The hypothesis that the Vielight Neuro RX Gamma device could be effective for the recovery of patients who are suffering from Post COVID-19 cognitive impairment will be tested in a randomized double blind clinical trial.
The Vielight research team is now looking to recruit subjects who are:
- Between the ages of 18 and 65 years old
- Residents of the United States
- Experiencing cognitive impairment due to a past COVID-19 infection.
The trial will be conducted remotely with participants using the study device and completing assessments on a computer in their homes. Investigators from Ascada Research, located in Fullerton, California, will provide secure video consultations to communicate with the trial participants.
Research Supporting the Trial
“We have designed the Vielight Neuro RX Gamma device with specific parameters that we believe would be safe and effective for treating post-COVID cognitive impairment.” said Dr. Lew Lim, founder and CEO of Vielight. “It is affordable, comfortable and suitable for home-use, but now needs to undergo this clinical trial for validation.”
Trial Format and Recruitment
The randomized double-blind trial seeks to enroll 36 participants who had COVID-19 infection and are suffering impaired cognition. In this study 18 participants will be randomized to be treated with the active Vielight Neuro RX Gamma device and the other 18 participants with the sham device. The devices will automatically shut off at the end of the 20-minute treatment session. Recruitment for participants is currently open; it will close when the target number of 36 qualified participants is reached. Data will be captured electronically from online questionnaires. Support and oversight are carried out by medically qualified investigators, with all best-practice safety measures in place. All communications are relayed remotely.
More information is accessible here at ClinicalTrials.gov
Media Contact
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About Vielight Inc.
Vielight Inc. is a market leader in the field of photobiomodulation (PBM) light therapy research and product innovation. For over a decade, our team of researchers together with our partners from leading universities, healthcare organizations and government agencies have been dedicated to advancing our knowledge of photobiomodulation. The company is currently conducting several clinical trials to investigate the use of its Vielight PBM devices for Alzheimer’s disease, traumatic brain injury, enhanced brain functions and sports performance. Our patented Vielight PBM devices are available for sale through medical practitioners, doctors and direct to the public. More information can be found at https://www.vielight