TY - JOUR

T1 - Study on the effect of 40 Hz non-invasive light therapy system. A protocol for a randomized, double-blinded, placebo-controlled clinical trial

AU - Agger, Mikkel Pejstrup

AU - Horning, Maibritt

AU - Carstensen, Marcus Schultz

AU - Danielsen, Else Rubæk

AU - Baandrup, Anders Olhues

AU - Nguyen, Mai

AU - Høgh, Peter

AU - Miskowiak, Kamilla

AU - Petersen, Paul Michael

AU - Madsen, Kristoffer Hougaard

AU - Kjær, Troels Wesenberg

N1 - Publisher Copyright: Copyright © 2023 Agger, Horning, Carstensen, Danielsen, Baandrup, Nguyen, Høgh, Miskowiak, Petersen, Madsen and Kjær.

PY - 2023

Y1 - 2023

N2 - Introduction: With no cure or effective treatment, the prevalence of patients with Alzheimer’s disease (AD) is expected to intensify, thereby increasing the social and financial burden on society. Light-based 40 Hz brain stimulation is considered a novel treatment strategy for patients with AD that may alleviate some of this burden. The clinical trial ALZLIGHT will utilize a novel Light Therapy System (LTS). The LTS uses Invisible Spectral Flicker for non-invasive induction of 40 Hz neural activity. This protocol describes a trial evaluating the efficacy and safety of a light-based 40 Hz brain stimulation in patients with mild-to-moderate AD. Methods: 62 patients with mild-to-moderate AD will participate in a randomized, double-blinded, placebo-controlled, parallel-group, and single-center trial. The participants will partake in an enrollment period of 1 month, an intervention period of 6 months, and a 1.5-month post-interventional follow-up period. Prior to the baseline measurement (week 0), the patients will be randomized to either active or placebo intervention from baseline (week 0) to post-intervention follow-up (week 26). Discussion: This protocol describes a randomized, double-blinded, placebo-controlled clinical trial that may increase the understanding of the effect of gamma oscillations in the human brain and how it could be utilized as a novel and important tool for the treatment of AD. The effect is measured through a large, multidisciplinary assessment battery. Clinical trial registration:www.ClinicalTrials.gov, (NCT05260177). Registered on March 2, 2022.

AB - Introduction: With no cure or effective treatment, the prevalence of patients with Alzheimer’s disease (AD) is expected to intensify, thereby increasing the social and financial burden on society. Light-based 40 Hz brain stimulation is considered a novel treatment strategy for patients with AD that may alleviate some of this burden. The clinical trial ALZLIGHT will utilize a novel Light Therapy System (LTS). The LTS uses Invisible Spectral Flicker for non-invasive induction of 40 Hz neural activity. This protocol describes a trial evaluating the efficacy and safety of a light-based 40 Hz brain stimulation in patients with mild-to-moderate AD. Methods: 62 patients with mild-to-moderate AD will participate in a randomized, double-blinded, placebo-controlled, parallel-group, and single-center trial. The participants will partake in an enrollment period of 1 month, an intervention period of 6 months, and a 1.5-month post-interventional follow-up period. Prior to the baseline measurement (week 0), the patients will be randomized to either active or placebo intervention from baseline (week 0) to post-intervention follow-up (week 26). Discussion: This protocol describes a randomized, double-blinded, placebo-controlled clinical trial that may increase the understanding of the effect of gamma oscillations in the human brain and how it could be utilized as a novel and important tool for the treatment of AD. The effect is measured through a large, multidisciplinary assessment battery. Clinical trial registration:www.ClinicalTrials.gov, (NCT05260177). Registered on March 2, 2022.

KW - 40 Hz

KW - Alzheimer’s disease

KW - gamma entrainment

KW - Invisible Spectral Flicker

KW - light-based neurostimulation

U2 - 10.3389/fnagi.2023.1250626

DO - 10.3389/fnagi.2023.1250626

M3 - Journal article

C2 - 37901795

AN - SCOPUS:85174966502

VL - 15

JO - Frontiers in Aging Neuroscience

JF - Frontiers in Aging Neuroscience

SN - 1663-4365

M1 - 1250626

ER -