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

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  • Mikkel Pejstrup Agger
  • Maibritt Horning
  • Marcus Schultz Carstensen
  • Else Rubæk Danielsen
  • Anders Olhues Baandrup
  • Mai Nguyen
  • Høgh, Peter
  • Miskowiak, Kamilla
  • Paul Michael Petersen
  • Kristoffer Hougaard Madsen
  • Troels Wesenberg Kjær

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.

OriginalsprogEngelsk
Artikelnummer1250626
TidsskriftFrontiers in Aging Neuroscience
Vol/bind15
Antal sider9
ISSN1663-4365
DOI
StatusUdgivet - 2023

Bibliografisk note

Funding Information:
We would like to thank the KID Foundation, the European Union’s Horizon 2020 research and innovation program and Region Sjællands Sundhedsvidenskabelige Forskningsfond for their support.

Funding Information:
This project was funded by the “European Union’s Horizon 2020 research and innovation programme under the Marie Skłodowska-Curie grant agreement No 956325,” by “Region Sjællands Sundhedsvidenskabelige Forskningsfond (RSSF) 2020/2021 grant number: 22A657 and by the KID Foundation Grant Number: 07654.

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

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