Evidence map›Paper›PMID 38767238›Full record

ArticleAnnals of medicine2024

Rationale and design of a double-blinded, randomized placebo-controlled trial of 40 Hz light neurostimulation therapy for depression (FELIX).

Laura Sakalauskaitė, Luna S Hansen, Julie Margrethe Dubois, Malina Ploug Larsen, Gustavo Miguel Feijóo, Marcus S Carstensen, Kamilla Woznica Miskowiak, Mai Nguyen, Line Katrine Harder Clemmensen, Paul Michael Petersen and 1 more

Abstract readClinical Trial Protocol
In one paragraph

Article in Annals of medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Laura SakalauskaitėNew Interventions in Depression Group (NID-Group), Copenhagen Affective Disorder Research Centre (CADIC), Psychiatric Centre Copenhagen, Copenhagen University Hospital, Copenhagen, Denmark.ORCID 0009-0002-5669-6089
Luna S HansenOptoCeutics ApS, Lyngby, Denmark.ORCID 0000-0001-5158-1309
Julie Margrethe DuboisNew Interventions in Depression Group (NID-Group), Copenhagen Affective Disorder Research Centre (CADIC), Psychiatric Centre Copenhagen, Copenhagen University Hospital, Copenhagen, Denmark.
Malina Ploug LarsenNew Interventions in Depression Group (NID-Group), Copenhagen Affective Disorder Research Centre (CADIC), Psychiatric Centre Copenhagen, Copenhagen University Hospital, Copenhagen, Denmark.ORCID 0009-0005-9216-5332
Gustavo Miguel FeijóoOptoCeutics ApS, Lyngby, Denmark.ORCID 0000-0002-9956-541X
Marcus S CarstensenDepartment of Electrical and Photonics Engineering, The Technical University of Denmark.ORCID 0000-0001-9312-0906
Kamilla Woznica MiskowiakNeurocognition and Emotion in Affective Disorders (NEAD) Group, Copenhagen Affective Disorders Research Center (CADIC), Psychiatric Centre Copenhagen, Copenhagen University Hospital, Copenhagen, Denmark.ORCID 0000-0003-2572-1384
Mai NguyenOptoCeutics ApS, Lyngby, Denmark.ORCID 0000-0003-0210-7664
Line Katrine Harder ClemmensenDepartment of Applied Mathematics and Computer Science, The Technical University of Denmark, Lyngby, Denmark.ORCID 0000-0001-5527-5798
Paul Michael PetersenDepartment of Electrical and Photonics Engineering, The Technical University of Denmark.ORCID 0000-0002-4202-4655
Klaus MartinyNew Interventions in Depression Group (NID-Group), Copenhagen Affective Disorder Research Centre (CADIC), Psychiatric Centre Copenhagen, Copenhagen University Hospital, Copenhagen, Denmark.ORCID 0000-0002-7317-5958

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMajor depressive disorder (MDD) is a debilitating condition that affects more than 300 million people worldwide. Current treatments are based on a trial-and-error approach, and reliable biomarkers are needed for more informed and personalized treatment solutions. One of the potential biomarkers, gamma-frequency (30-80 Hz) brainwaves, are hypothesized to originate from the excitatory-inhibitory interaction between the pyramidal cells and interneurons. The imbalance between this interaction is described as a crucial pathological mechanism in neuropsychiatric conditions, including MDD, and the modulation of this pathological interaction has been investigated as a potential target. Previous studies attempted to induce gamma activity in the brain using rhythmic light and sound stimuli (GENUS - Gamma Entrainment Using Sensory stimuli) that resulted in neuroprotective effects in Alzheimer's disease (AD) patients and animal models. Here, we investigate the antidepressant, cognitive, and electrophysiological effects of the novel light therapy approach using 40 Hz masked flickering light for patients diagnosed with MDD. METHODS AND

designSixty patients with a current diagnosis of a major depressive episode will be enrolled in a randomized, double-blinded, placebo-controlled trial. The active treatment group will receive 40 Hz masked flickering light stimulation while the control group will receive continuous light matched in color temperature and brightness. Patients in both groups will get daily light treatment in their own homes and will attend four follow-up visits to assess the symptoms of depression, including depression severity measured by Hamilton Depression Rating Scale (HAM-D

Indexed as

Major Depressive DisorderAdolescentAdultAgedDouble-Blind MethodElectroencephalographyFemaleGamma RhythmHumansMaleMiddle AgedPhototherapyRandomized Controlled Trials as TopicTreatment OutcomeYoung Adult40 Hz stimulationcognitiongamma brainwavesLight stimulationmajor depressive disordervisual flicker

Identifiers

PMID38767238
PMCPMC11107857

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.