Evidence map›Paper›PMID 40437278›Full record

Trial reportLasers in medical science2025

Dose-dependent tolerability and safety of transcranial photobiomodulation: a randomized controlled trial.

David R A Coelho, Willians Fernando Vieira, Aura Maria Hurtado Puerto, Maia B Gersten, Katherine Anne Collins, Anna Peterson, Kari Siu, Ümit Tural, Dan Vlad Iosifescu, Paolo Cassano

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Lasers in medical science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. [A simulation study of photothermal effects in transcranial photobiomodulation].Sheng wu yi xue gong cheng xue za zhi = Journal of biomedical engineering = Shengwu yixue gongchengxue zazhi · 2026
    Article
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

10 authors.

David R A CoelhoDivision of Neuropsychiatry and Neuromodulation, Massachusetts General Hospital, Boston, USA. daraujocoelho@mgh.harvard.edu.
Willians Fernando VieiraDivision of Neuropsychiatry and Neuromodulation, Massachusetts General Hospital, Boston, USA.
Aura Maria Hurtado PuertoDivision of Neuropsychiatry and Neuromodulation, Massachusetts General Hospital, Boston, USA.
Maia B GerstenDivision of Neuropsychiatry and Neuromodulation, Massachusetts General Hospital, Boston, USA.
Katherine Anne CollinsNathan Kline Institute for Psychiatric Research, Orangeburg, USA.
Anna PetersonDepartment of Psychiatry, New York University Grossman School of Medicine, New York City, USA.
Kari SiuNathan Kline Institute for Psychiatric Research, Orangeburg, USA.
Ümit TuralNathan Kline Institute for Psychiatric Research, Orangeburg, USA.
Dan Vlad IosifescuNathan Kline Institute for Psychiatric Research, Orangeburg, USA.
Paolo CassanoDivision of Neuropsychiatry and Neuromodulation, Massachusetts General Hospital, Boston, USA.

Funding

US National Institute of Mental Health R61/R33 MH122647
6 · The paper itself

Abstract

Transcranial photobiomodulation (t-PBM) with near-infrared (NIR) light has emerged as a promising therapy for major depressive disorder (MDD). However, the dose-dependent tolerability of t-PBM has not been adequately explored. This secondary analysis of a sham-controlled clinical trial evaluated the safety and tolerability of t-PBM across varying doses in 31 subjects with MDD. Participants were randomly assigned to receive four sessions of NIR (808 nm) t-PBM (sham, low, medium, and high doses) approximately one week apart. The outcome was the emergence of side effects, assessed by the Systematic Assessment for Treatment-Emergent Effects-Specific Inquiry (SAFTEE-SI) scale. The frequency of side effects, compared to baseline or the prior week, was analyzed using Cochran's Q test. Additionally, body weight and systolic and diastolic blood pressures (SBP and DBP, respectively) were recorded and assessed with repeated measures ANOVA. The results showed no statistically significant changes in rates of any adverse events compared to baseline or prior week. The most notable rate increases were in "delayed or absent orgasm" for the medium dose compared to baseline among 10% of participants (Cochran's Q = 6.231; p = 0.101), and in "ringing in ears or trouble hearing" for the high dose compared to the prior week among 13% of participants (Cochran's Q = 6.231; p = 0.101). There were no significant changes in weight or SBP and DBP (F

Indexed as

Low-Level Light TherapyMajor Depressive DisorderAdultDose-Response Relationship, RadiationFemaleHumansMaleMiddle AgedTreatment OutcomeYoung AdultDose-dependentSafetyTolerabilityTranscranial photobiomodulation

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.