NCT06618807

Infrared Light for Memory Loss in Mild Cognitive Impairment (MCI)

A Pilot Study Evaluating the Feasibility, Safety, and Efficacy of the Neuro RX Gamma (Version 2) for the Treatment of Mild Cognitive Impairment (MCI)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

Mild cognitive impairment (MCI) is a transitional risk state that occurs between the normal aging process and Alzheimer's dementia (AD). On average 32% of patients with MCI will progress to dementia, 62% will stay stable, and about 6% will return to normal cognition at subsequent visits. Current treatment for MCI includes cholinesterase inhibitors (donepezil, galantamine and rivastigmine), and NMDA receptor antagonists (memantine) which delay or slow the worsening of symptoms and treat cognitive symptoms (memory loss, confusion, and problems with thinking and reasoning). Despite currently ongoing drug studies and modest clinical benefits of currently approved drug treatments, there continues to remain a need for treatments for long term symptomatic improvement of MCI with fewer and less severe side effects. Photobiomodulation (PBM) therapy also called low-level laser (or light) therapy (LLLT) is a safe, non-invasive, non-thermal (no significant heat is generated) method of therapy which uses either visible red or near-infrared (NIR) light to stimulate, heal and repair damaged or dying tissue cells. This study proposes to use the Neuro RX Gamma device (version 2) to deliver NIR light energy to particular brain regions which are dysfunctional in MCI participants.

Detailed description

This study will recruit approximately 60 participants with MCI for the study, and the total expected duration of the participant's participation in the study is 12 weeks. The active and sham Neuro RX gamma device (v2) consists of a headset with a built-in controller and nasal applicator. The nasal applicator contains a single LED and will be placed into the nostril and clipped into place. The headset is a wearable applicator that may be adjusted. It consists of 5 LEDs. A red star symbol identifies the front of the headset and helps the user orientate the headset on the head. LEDs are semiconductor electronic components that emit light.

Conditions

• Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease

Interventions

Type	Name	Description
DEVICE	Active tPBM device	The Neuro RX Gamma (version 2) delivers a synchronized pulse frequency of 40 Hz from all LED clusters. The gamma pulse frequency of 40 Hz has been demonstrated to attenuate amyloid beta proteins production in the hippocampus and modulate microglial activity resulting in increased scavenging of amyloid beta which may lead to improving cognition in MCI. Finally, the Vielight Neuro RX Gamma (version 2) has been designed to target the delivery of NIR energy to particular brain regions; specifically the default mode network (DMN). The active intervention device proceeds to deliver light to each LED at 40 Hz with a 50% duty cycle for 20 minutes and stops automatically. During the 20 minute treatment the power indicator LED on the controller flashes green at 40 Hz. The operator is notified that the treatment is finished when the power indicator LED on the controller stops flashing and the device beeps 2 times.
DEVICE	Sham device	The sham device delivers infrared light for only a few seconds before stopping. The controller will still show a green light to maintain the study\'s blinding. If the headset is removed, the device will emit a beep and cease functioning.

Timeline

• Start date: 2025-01-10
• Primary completion: 2027-08-01
• Completion: 2028-03-01
• First posted: 2024-10-01
• Last updated: 2025-12-05

Locations

1 site across 1 country: Canada