NCT03328195

Vielight Neuro RX Gamma - Feasibility Pilot

A Pilot Study Evaluating the Feasibility, Safety, and Efficacy of the Vielight Neuro RX Gamma Device for the Treatment of Moderate-to-severe Alzheimer's Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Vielight Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This study tests the effects of the Neuro RX Gamma synchronous and asynchronous devices on the cognitive and behavioral functioning of subjects with moderate-to-severe Alzheimer's Disease. The Neuro RX Gamma is non-invasive and delivers near-infrared energy to the brain in daily treatment sessions at home. An optional substudy will involve the use of the Electroencephalogram (EEG) to assess the effect of the treatment devices on the electrical activity of the brain compared to sham.

Detailed description

The Neuro RX Gamma system is a headset which emits pulsed near-infrared energy synchronously or asynchronously through diodes placed on the scalp and inside a nostril. A potential participant will undergo screening procedures to confirm eligibility to participate in the study, followed by randomization procedure to one of the study groups - treatment synchronized, treatment asynchronized or sham (placebo). A dedicated caregiver will apply the device to the subject for 20 minute daily sessions at home, 6 days a week for a total of 12 weeks. The subject and caregiver will be required to return to the clinic for follow-up assessments after 3, 6 and 12 weeks of treatment. Participants will have the choice of opting into a substudy involving the collection of rest EEG recordings during the baseline and weeks 3, 6 and 12 visits. 60 patients will be enrolled in 2 clinical sites in Ontario, Canada.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DEVICE	Neuro RX Gamma synchronous	Twenty minute treatment, six days per week for 12 weeks
DEVICE	Sham	Twenty minutes, six days per week for 12 weeks with sham device
DEVICE	Neuro RX Gamma asynchronous	Twenty minutes, six days per week for 12 weeks with sham device

Timeline

• Start date: 2017-12-04
• Primary completion: 2021-11-12
• Completion: 2022-02-28
• First posted: 2017-11-01
• Last updated: 2023-01-25

Locations

1 site across 1 country: Canada