CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 23 enrolled
Drug / intervention
Vielight Neuro Gamma +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03405662
NCT03405662N/ACompleted

Examining the Impact of Photobiomodulation on Cognition, Behavior, and Biomarkers of Alzheimer's Disease

University of California, San Francisco·interventional·Posted Jan 23, 2018·Updated Jul 1, 2022

In Brief

A clinical study evaluating Vielight Neuro Gamma and Sham Vielight Neuro Gamma for Alzheimer Disease. Completed, enrolled 23 participants across 2 sites.

Detailed Summary

Photobiomodulation (PBM) describes the use of near-infrared light (which is not visible to the eye) to heal and protect tissue that has either been injured, is degenerating, or else is at risk of dying. Research suggests that the light delivered during PBM enhances the body's biochemical ability to store and use energy and increase blood flow, which triggers the body's natural healing processes. The primary goal of this study is to determine if PBM administered transcranially (through the scalp and skull) and intranasally (inside the nose) with a commercially available device is safe and tolerable for patients with mild-to-moderate Alzheimer's disease (AD). Secondary goals are to examine whether tPBM has an effect on cognitive function and behavioral symptoms in patients with AD and whether tPBM has an effect on fluid biomarkers of AD. A biomarker is a specific physical trait used to measure the progress of a disease or condition.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJan 23, 2018
Enrollment StartAug 16, 2018
Primary CompletionJan 1, 2021
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 8.4 years ago

Interventions

Vielight Neuro Gammadevice

The Vielight Neuro Gamma is headset that delivers transcranial (through the scalp and skull) and intranasal (through the nose) near infrared (NIR) light. The device is engineered for increased efficacy and easy domestic use for comprehensive brain photobiomodulation (PBM). The NIR lights are pulsed at a 40 Hz rate, which correlates with electroencephalogram (EEG) gamma brain wave entrainment.

Sham Vielight Neuro Gammaother

The Sham Vielight Neuro Gamma headset is identical to the active Vielight Neuro Gamma headset and intranasal light emitting diode (LED) except it has a power output of 0.