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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Study on the effect of 40 Hz non-invasive light therapy system. A protocol for a randomized, double-blinded, placebo-controlled clinical trial. / Agger, Mikkel Pejstrup; Horning, Maibritt; Carstensen, Marcus Schultz; Danielsen, Else Rubæk; Baandrup, Anders Olhues; Nguyen, Mai; Høgh, Peter; Miskowiak, Kamilla; Petersen, Paul Michael; Madsen, Kristoffer Hougaard; Kjær, Troels Wesenberg.
I: Frontiers in Aging Neuroscience, Bind 15, 1250626, 2023.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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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 -
ID: 388331133