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STUDY PROTOCOL article

Front. Neurol.
Sec. Neurotechnology
Volume 15 - 2024 | doi: 10.3389/fneur.2024.1371284
This article is part of the Research Topic Photobiomodulation Therapy for Brain Disorders View all articles

A randomized sham-controlled trial of transcranial and intranasal photobiomodulation in Japanese patients with mild cognitive impairment and mild dementia due to Alzhimer's disease: a protocol

Provisionally accepted
Yuma Yokoi Yuma Yokoi *Takuma Inagawa Takuma Inagawa Yuji Yamada Yuji Yamada Makoto Matsui Makoto Matsui Asumi Tomizawa Asumi Tomizawa Takamasa NODA Takamasa NODA
  • National Center of Neurology and Psychiatry (Japan), Kodaira, Japan

The final, formatted version of the article will be published soon.

    Introduction Photobiomodulation (PBM) is a novel strategy for cognitive enhancement by improving brain metabolism and blood flow. It is potentially beneficial for patients with Alzheimer's disease (AD). We present a study protocol for a randomised controlled trial designed to evaluate the efficacy and safety of PBM.This is a single-centre, parallel-group, randomised, sham-controlled study. We enrol patients with mild cognitive impairment or dementia due to AD and assigned them to receive either active or sham stimulation at home for 12 weeks, with three sessions per week (20 minutes each). The stimulation involves invisible near-infrared light delivered by five applicators (one in a nostril, one on the frontal scalp, and three on the occipital scalp). The primary outcome will be the mean change in the Alzheimer Disease Assessment Scale-cognition from baseline to Week 12. We will also measure cognitive function, activity of daily living, behavioural and psychological symptoms, and caregiver burden. We will collect data at clinics at baseline and Week 12 and remotely at home. We estimate a sample size of 30 (20 active and 10 sham) based on an expected mean difference of -6.9 and an SD of 4.8. We use linear models for the statistical analysis.Trial registration details Japan Registry of Clinical Trials jRCTs032230339.

    Keywords: photobiomodulation, Mild Cognitive Impairment, Alzheimer's disease, decentralized trial, Cognitive Function

    Received: 16 Jan 2024; Accepted: 29 May 2024.

    Copyright: © 2024 Yokoi, Inagawa, Yamada, Matsui, Tomizawa and NODA. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Yuma Yokoi, National Center of Neurology and Psychiatry (Japan), Kodaira, Japan

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.