1. Introduction
Version followed: transcranial photobiomodulation (t-PBM) as described in published research reviews and trial consent documents from the Mount Sinai, NYU, Nathan Kline Institute and Massachusetts General Hospital groups (Askalsky and Iosifescu 2019; Cassano and Iosifescu safety analysis 2022; NIH-funded trial consent forms), the Ji et al. 2024 meta-analysis, and US regulatory material checked October 2026. The guide is written for a psychotherapist working alongside a research team, a physician or a client who has bought a consumer device. It is not a psychotherapy and it is not a treatment the psychotherapist delivers.
Status label: contested, research-stage method for mental health and cognitive conditions. As of October 2026, no source opened shows any regulatory clearance of a light device for depression, anxiety, dementia or other psychiatric or cognitive conditions. [source: NCT04366258 and NCT04784416 consent forms; Alzforum therapeutics page 2024; BBRF 2022]
What it is: photobiomodulation (also called low-level light or laser therapy, and marketed as "red light therapy") is the application of red or near-infrared light from a laser or LED device. In the transcranial form, light is aimed through the scalp and skull with the aim of acting on the brain. [source: Askalsky and Iosifescu 2019]
Proposed mechanism, as its researchers state it (hypothesis, not established): light reaching the cortex is absorbed by a mitochondrial enzyme, cytochrome c oxidase, possibly increasing cellular energy production. Other proposed effects (on blood flow, nitric oxide signalling, oxidative stress, inflammation and cell survival) come partly from animal studies. The same authors note that how much light gets through hair, scalp and skull is a key unanswered question. A 2026 Nature feature (reprinted in Scientific American) also describes getting enough light through the skull as an unsolved problem. [source: Askalsky and Iosifescu 2019; Peeples 2026]
For the psychotherapist, change does not come from the device. Your contribution is to keep the client's evidence-based care in place, support informed decisions, and watch for adverse effects and deterioration. [synthesis]
2. Framework
This is not a phased therapy, so the framework describes (a) where the method stands in regulation and evidence and (b) the phases of the psychotherapist's involvement.
2a. Regulatory status (date checked: October 2026)
- United States, devices for the brain or mental health: NIH-funded trial consent forms state that the near-infrared device used is FDA-cleared for muscle aches and joint pain, "not, however, FDA approved to treat depression" (NCT04366258), and not cleared for mild cognitive impairment (NCT04784416); both call the procedures experimental. Alzforum (May 2024) lists FDA status for Alzheimer's disease, mild cognitive impairment and Parkinson's disease as "Not Regulated". The Cassano and Iosifescu team stated in 2022 that t-PBM is not FDA-approved and that large trials in depression and anxiety had not yet been done. [source: consent forms; Alzforum; BBRF 2022]
- United States, other indications: Ji et al. (2024) state that FDA has cleared photobiomodulation for peripheral pain. A 2026 MedCity News commentary lists consumer devices with 510(k) clearance for specific cosmetic and hair indications. Scientific American/Nature (March 2026) reports that FDA authorised one red-light device for dry age-related macular degeneration (a De Novo authorisation for the Valeda system, per MedCity News). None of these is a psychiatric indication. [source: Ji et al. 2024; Kamasani, MedCity News 2026; Peeples 2026]
- US consumer "wellness" route: FDA's General Wellness guidance (final, January 2026) covers low-risk products that promote a healthy lifestyle and are not intended to diagnose, cure, mitigate, prevent or treat disease. According to a law-firm summary, a product is not low-risk if it uses technology that poses a safety risk without specific controls. Whether a given light device qualifies depends on the product and its claims [uncertain]. "FDA-registered" means only that a facility and device are listed with FDA; it does not mean the device was cleared. [source: FDA guidance page; Troutman Pepper 2026; MedCity News 2026]
- Ages: no paediatric or adult psychiatric indication was found for any light device. Trials for autistic traits in children and adolescents with ADHD are registered (NCT04569058), which makes this a research question in young people, not a cleared use. [source: ClinicalTrials.gov registry listing] [uncertain]
- UK, EU, Canada, Australia: no regulator or NICE statement on transcranial photobiomodulation for mental health was found in this research [uncertain]. Australia's TGA recalled a consumer LED acne mask in 2019 over the risk of retinal damage (see section 4). [source: the limbic 2019; CosmeticsDesign-Asia 2019]
2b. Evidence status, attributed
- Ji et al. (2024, Frontiers in Psychiatry): a meta-analysis of 11 RCTs (407 participants) concluding that PBM reduces depression symptoms, with GRADE certainty rated moderate for depression and very low for sleep. The authors list as limitations small samples, unclear blinding in some trials, and heterogeneity in treatment sites, doses and wavelengths. A correction was published in 2025 and was not reviewed. [source: Ji et al. 2024]
- Askalsky and Iosifescu (2019): human studies are mostly small, open-label or pilot studies of mixed design. Optimal parameters are unknown, whether LED devices work as well as lasers is unclear, and skin colour may affect absorption. They call for large confirmatory trials. [source: Askalsky and Iosifescu 2019]
- An open-label pilot (Monteiro et al., 2026; 29 outpatients with treatment-resistant depression; no control group) reported an intention-to-treat response rate of 31.0% and remission of 6.9%, and says sham-controlled trials "are warranted to confirm efficacy". [source: Monteiro et al. 2026, abstract only]
- Dementia: small pilot results are mixed, including a UCSF follow-up that reported "no changes with treatment in cognition or biomarkers"; larger trials were ongoing or unpublished as of the May 2024 Alzforum update. [source: Alzforum 2024]
- Consumer devices: experts quoted in Nature/Scientific American (2026) say some products "fail to deliver a therapeutic dose" and call for independent testing; a rehabilitation physician quoted by Utah Public Radio (2026) calls red light "not a standalone treatment". [source: Peeples 2026; Helcoski, UPR 2026]
2c. Phases of the psychotherapist's involvement [synthesis]
- First mention: the client asks about, has bought, or is enrolled in t-PBM. Goal: find out what, why, from whom and under whose supervision. Move on once you know the device or study, the source of the claims, and whether a physician or research team is involved.
- Decision support: usually 1–2 sessions, built into ongoing therapy. Goal: an informed choice that keeps established care in place. Move on once the client has the facts, has the questions to ask the prescriber or study team, and has agreed a plan for monitoring.
- During use or a trial: ongoing. Goal: track mood, sleep, irritability, side effects and risk using the same measures you already use, and pass concerns on to the medical lead.
- After: goal: review what changed, deal with disappointment or over-attribution, and consolidate the psychological work.
3. Guiding principles
- Neutral, not endorsing. Do not recommend, sell, lend or demonstrate devices. Practical meaning: you discuss the evidence and do not prescribe. [synthesis]
- Name the label honestly. It is research-stage and contested for mental health. Practical meaning: use words like "experimental" and "not cleared for depression", which match the trial consent forms. [source: NCT04366258 consent form]
- Attribute every claim. Practical meaning: say who claims what ("a 2024 meta-analysis reported…", "the company says…"). Do not state mechanisms as fact. [synthesis]
- Established care first. Practical meaning: help the client avoid replacing evidence-based treatment with a device. Trial consent forms list medication, TMS, ECT and psychotherapy as the alternatives. [source: NCT04366258 consent form]
- Medical questions go to medical people. Practical meaning: questions about skin, eyes, stroke history, pregnancy, photosensitising medicines and medication changes go to the client's physician, eye specialist or study team. [source: consent forms; synthesis]
- No settings, no DIY coaching. Practical meaning: never advise on device settings, where to put a device or how often to use it. Point the client to the prescriber, study team or manufacturer's labelling. [synthesis]
- Eye safety as the sources state it. Practical meaning: know that trial consent forms list retinal damage from accidental laser exposure and require protective goggles throughout, and that a regulator recalled a consumer LED mask over retinal risk in susceptible people. [source: consent forms; TGA via the limbic 2019]
- Monitor, do not assume. Practical meaning: keep measuring outcomes and risk, because a hoped-for device effect can hide deterioration. One consent form lists worsening depression as a risk. [source: NCT04366258 consent form; synthesis]
- Respect autonomy. Practical meaning: an adult client may still choose to use a consumer device. Your job is safety and information, not permission. [synthesis]
- Watch for consumer-marketing harms. Practical meaning: check for "FDA-registered" presented as "FDA-cleared", disease claims made under a wellness label, high prices and pressure to buy. [source: MedCity News 2026; FDA General Wellness guidance 2026]
4. Intervention inventory
Part A describes how the method is delivered, at the level sources give and only for orientation. Part B covers the psychotherapist's own interventions. No device settings, dose, timing or placement appear here. Refer such questions to the study team, the physician or the manufacturer's labelling.
A1. How t-PBM is delivered in research settings (descriptive only)
- Purpose: to let you explain to a client what taking part in a trial involves.
- What sources describe: in NIH-funded trials, study staff deliver the treatment in an office using a headgear unit linked by cable to a laser device. The device is programmed in advance to give either active light or sham, so neither participant nor rater knows which. Participants wear protective goggles throughout. Screening includes a physical examination, ECG, blood and urine tests, a pregnancy test and a drug screen. Skin lesions where the device sits exclude treatment. A Data and Safety Monitoring Board oversees the trial, participants report side effects at visits and can phone staff between visits. In one depression trial, participants could continue existing depression treatment but could not start or change any until the study ended. [source: NCT04366258 and NCT04784416 consent forms]
- Side effects listed in consent forms: common ones are disturbed sleep, irritability and seeing vivid colours. Rare ones include skin reddening, peeling or burns (if misused), pain or warmth where the device sits, headache-type discomfort, nausea, neck pain, vivid dreams, word-finding difficulty, memory loss, abnormal taste, "out-of-body" experiences and worsening depression. There is a possible clotting risk at the site of a previous stroke, and retinal damage from accidental laser exposure, which could cause blindness. [source: consent forms]. A pooled safety analysis (80 participants, three studies) found headache, vivid colours and irritability most common and no link between number of sessions and adverse events; the authors say the sample is too small to be definitive. [source: BBRF 2022]
- Watch for: clients describing a trial as "treatment". It is research, and benefit after the study may not be available because the treatment is not approved for that condition. [source: NCT04784416 consent form]
- Example language (illustrative): "In the research studies, staff give the light treatment in a clinic while you wear goggles, and neither you nor the raters know whether the device is real or sham. The consent form lists the possible side effects; let's read it together." [synthesis]
A2. How consumer and home devices are sold (descriptive only)
- Purpose: to recognise what a client has bought.
- What sources describe: helmets, headbands, panels and masks are sold directly to consumers. Some have 510(k) clearance for a specific non-psychiatric indication. Others are sold under the General Wellness policy without premarket review, provided they make no disease claims. Prices range from about $10 to tens of thousands of dollars. Many consumer devices "have not been extensively or independently tested", and testing has found some fall short of their stated output. Researchers have described t-PBM as "easy to self-administer" and see home use as possible, while questioning whether LED devices are effective for the brain. [source: MedCity News 2026; UPR 2026; Peeples 2026; Askalsky and Iosifescu 2019]
- Documented consumer-device risks: Australia's TGA recalled the Neutrogena Visibly Clear Light Therapy Acne Mask in 2019 because repeated exposure "may cause varying degrees of retinal damage". The risk applied mainly to people with retinitis pigmentosa, ocular albinism or other congenital retinal disorders. The manufacturer added that people taking medicines that increase ocular photosensitivity may face a theoretical risk. The TGA told clinicians to inform patients, advise them to stop using it and report adverse effects. A source quoting Cleveland Clinic says improper use may damage skin or eyes, and long-term safety of repeated use is unknown. [source: the limbic 2019; CosmeticsDesign-Asia 2019; UPR 2026]. That recall concerned a facial mask, not a transcranial device; it is the regulator action on eye risk from consumer light devices found in this research. [uncertain as to transcranial products]
- Example language (illustrative): "A product being for sale, or 'FDA-registered', doesn't mean it has been cleared for depression. Shall we look at what this one actually says?" [synthesis]
- Watch for: devices bought without medical advice, eye-safety warnings ignored, or spending the client cannot afford. Working: the client checks claims and raises the device with a physician. [synthesis]
B1. Exploratory inquiry when a client raises it
- Purpose and when: whenever a client mentions red light, a light helmet, a clinic offering "brain light therapy" or a trial.
- Steps: (1) Ask what device or service it is, where they heard about it and what they hope it will do. (2) Ask whether a physician, study team or clinic is involved, and whether they have already bought it. (3) Ask what they believe its regulatory status to be. (4) Ask whether they are considering changing any current treatment. (5) Note it in the record and agree to come back to it. [synthesis]
- Example language (illustrative): "Tell me what you've read about it and what you're hoping it might change for you." "Is anyone medical involved, a doctor or a research team?"
- Watch for: hope tied to despair after failed treatments, financial pressure, a plan to drop current care. Working: the client is curious and open rather than defensive.
B2. Balanced psychoeducation on evidence and status
- Purpose and when: after B1, when the client wants your view on whether it works.
- Steps: (1) Say plainly that you do not deliver or recommend it and that your view is not medical advice. (2) Give the status: research-stage for mood and cognition. As of October 2026, no source shows clearance for any psychiatric condition, and trial consent forms call it experimental. (3) Give the evidence with attribution: one 2024 meta-analysis of small trials reported reduced depressive symptoms, with moderate certainty; researchers in the field say larger sham-controlled trials are needed and settings are not established; dementia results are mixed. (4) Name the proposed mechanism as a hypothesis. (5) Name known side effects and eye risk as sources list them. (6) Ask what they make of it. [source: sections 1–2 sources; synthesis for steps]
- Example language (illustrative): "Researchers are studying it seriously, and some small trials look encouraging. It hasn't been cleared for depression, and the researchers themselves say bigger trials are needed."
- Watch for: the client hearing only the hopeful half, or hearing your caution as dismissal. Working: the client can summarise both sides back to you in their own words.
B3. Appraising marketing claims together
- Purpose and when: the client has a product page, advert or influencer video.
- Steps: (1) Look at the claim with them, not for them. (2) Check whether it says "cleared" (and for what) or only "registered". Registration is not clearance. (3) Check whether disease words (depression, anxiety, ADHD, dementia) appear on a product sold as "wellness". (4) Check who funded the cited studies, how big they were and whether they had a sham group. (5) Note sweeping promises; a UCL researcher quoted in Nature criticised "You'll live forever"-style claims. (6) Suggest the client take the page to their physician or pharmacist. [source: MedCity News 2026; FDA General Wellness guidance 2026; Peeples 2026; steps synthesis]
- Example language (illustrative): "Let's look at exactly what this page says it's cleared for. Does it say cleared, or registered?"
- Watch for: shame at having bought something. Normalise it. Working: the client starts questioning claims themselves.
B4. Supporting informed consent for a research trial
- Purpose and when: the client is invited into or enrolled in a t-PBM study.
- Steps: (1) Encourage them to read the consent form and bring questions; do not interpret it for them as medical advice. (2) Help them list questions for the team: Is it experimental? What are the sham chances? What side effects are listed? What eye protection is used? What happens to my current treatment? Who do I call if I get worse? What is available after the study? (3) Explore what it would mean for them to get sham, or no benefit. (4) Check whether trial rules would delay a treatment change they need. One consent form says starting or changing depression treatment is not allowed until the study ends. (5) Confirm they know participation is voluntary and that refusing does not affect their care. [source: NCT04366258 consent form; steps synthesis]
- Example language (illustrative): "What would it be like if, at the end, you found out you'd been in the sham group?"
- Watch for: feeling coerced by hope or payment, or not understanding the design. Working: the client can describe the study and their right to withdraw.
B5. Routing medical questions and suggesting medical review
- Purpose and when: whenever a question concerns the body, the eyes or medicines, or the client has a risk factor named in sources.
- Steps: (1) Ask the client to discuss the device with their physician or prescriber before use, and with the study team if in a trial. (2) Specifically flag, as sources raise them: a history of stroke (consent forms list a possible clotting risk at a previous stroke site); pregnancy (excluded from trials); skin lesions where the device would sit; known retinal or eye conditions, and medicines that may increase light sensitivity of the eye (raised in the TGA mask recall); any eye pain, blurred vision, spots, flashes or colour-vision change, which needs prompt eye review. (3) With consent, write or phone the physician. (4) Do not give a view on whether the client's medicines are compatible; that is the prescriber's call. [source: consent forms; the limbic 2019; steps synthesis]
- Example language (illustrative): "Some of what you're asking is a medical question about your eyes and medicines. Your GP or eye specialist is the right person. Shall we write the questions down now?"
- Watch for: the client avoiding medical contact because they expect disapproval. Working: medical review happens before use or soon after.
B6. Collaborative care with the treating or research team
- Purpose and when: with consent, whenever a physician or study team is involved.
- Steps: (1) Get written consent to share information. (2) Tell the team you are providing psychotherapy and what measures you use. (3) Agree who to contact about side effects, deterioration or risk, and out of hours. (4) Send concise, factual updates (dates, observations, scores, client's words), with no interpretation of the device's effect. (5) If in a blinded trial, avoid asking about or guessing the arm, as this could unblind the trial. [synthesis]
- Example language (illustrative) to team: "With [client]'s consent: since [date] they report more irritability and poorer sleep; PHQ-9 up from X to Y; no suicidal intent. Passing on for your review."
- Watch for: splitting (team as hopeful, therapist as sceptic). Working: one shared plan and clear contacts.
B7. Conversations about ambivalence and current treatment
- Purpose and when: the client wants to drop medication, therapy or other treatment for the device, or is ambivalent.
- Steps: (1) Reflect both sides without arguing. (2) Explore what draws them: side effects of current treatment, cost, hope, mistrust. (3) State that decisions about medicines belong with the prescriber, and never advise starting, stopping or changing any. (4) Help them prepare for that conversation. (5) If they have already stopped a medicine, encourage prompt contact with the prescriber and watch closely. [synthesis]
- Example language (illustrative): "Part of you is hopeful about the light, and part of you is tired of the medication. Both make sense. Changing a medicine is something to plan with your prescriber, not on your own. Would it help to prepare what you want to say?"
- Watch for: abrupt stopping, secrecy. Working: the client brings the decision to the prescriber.
B8. Monitoring side effects and warning signs
- Purpose and when: throughout any use, home or trial.
- Steps: (1) Take a baseline with your usual measures (e.g. PHQ-9, GAD-7, a sleep log) before use where possible. (2) At each session ask briefly about sleep, irritability, headache, unusual visual experiences, dreams, word-finding or memory problems, skin problems and eye symptoms, which are the effects consent forms list. (3) Review mood and risk scores each session. (4) Pass new or worsening effects on to the physician or study team the same day for eye symptoms, burns, neurological symptoms or rising risk. (5) Record what was passed on and to whom. [source: consent forms for the effects; steps synthesis]
- Mood elevation (synthesis): none of the sources discusses switching into hypomania with t-PBM [uncertain]. Because disturbed sleep and irritability are listed effects, and any antidepressant-type intervention warrants vigilance in bipolar disorder, pass on signs such as reduced need for sleep, racing thoughts or disinhibition to the medical lead. [synthesis]
- Example language (illustrative): "Since you started using it, any changes in sleep, headaches, how irritable you feel, or anything odd with your eyesight?"
- Watch for: the client playing down side effects to keep using the device. Working: early reports and shared records.
B9. Crisis and safety planning
- Purpose and when: for any client with current or past suicidality, before and during device use or a trial.
- Steps: (1) Review or write a safety plan as usual (warning signs, coping, contacts, professional and emergency numbers, reducing access to means). (2) Add the study or clinic contact. One consent form tells participants to call the investigator or 911 if depression worsens or they have thoughts of harming themselves. (3) Plan for disappointment: what happens if the device does not help. (4) Agree that worsening is reported, not waited out. [source: NCT04366258 consent form; steps standard practice/synthesis]
- Example language (illustrative): "If things get worse while you're trying this, we treat it as important information, not something to push through. Let's put the study team's number on your plan."
- Watch for: hopelessness after a failed "last hope". Working: the plan is used and updated.
B10. Integrating psychotherapy before, during and after
- Purpose and when: throughout.
- Steps: (1) Before: keep therapy goals central, and frame the device as at most an add-on under medical oversight. (2) During: continue the existing model (CBT, behavioural activation etc.), keep the focus on the client's own actions, and avoid crediting changes to the device or to therapy alone. (3) After: review outcomes with data, help the client own the skills they used, and work through disappointment or over-attribution. (4) If the client keeps using a consumer device, keep monitoring (B8). [synthesis]
- Example language (illustrative): "Whatever the light did or didn't do, you also got out of bed and back to your walks. Let's look at what you did."
- Watch for: passivity ("the helmet will fix it"). Working: the client's own coping is active and recognised.
B11. Talking with parents about devices for children and adolescents
- Purpose and when: parents ask about light devices for ADHD, autism or a young person's mood.
- Steps: (1) Say that no source opened shows clearance for any psychiatric indication in young people, and that trials in this group exist, which is research, not established care. (2) Route to the child's paediatrician or psychiatrist, especially about eyes and skin. (3) Make sure evidence-based care for the young person goes ahead. (4) Explore the parents' worry and hope. [source: NCT04569058 listing [uncertain]; synthesis]
- Example language (illustrative): "It's being studied in young people, which tells us it isn't established yet. The paediatrician is the right person for the safety questions."
- Watch for: guilt or pressure from parent networks. Working: the decision is taken with the child's doctor.
B12. Responding to DIY use and home modification
- Purpose and when: the client builds, modifies or combines devices, uses higher-output products, or uses without eye protection.
- Steps: (1) Do not advise on technique or settings. (2) State documented risks: consent forms list skin burns if misused and retinal damage from accidental laser exposure (participants wear goggles throughout); a regulator recalled an LED mask over retinal damage; long-term safety of repeated use is unknown. (3) Encourage prompt review by a physician or eye specialist, and urgent review for any eye or skin symptoms; decisions about further use are for the client and that clinician. (4) Record the conversation. [source: consent forms; the limbic 2019; UPR 2026; steps synthesis]
- Example language (illustrative): "I can't advise on how to use it, but I can tell you what the research teams worry about: eye damage and skin burns. Could you get it checked with your doctor first?"
- Watch for: escalating use when no effect is felt. Working: the client seeks medical review.
5. Handling problems
The sources are research and regulatory documents and do not address psychotherapy problems. Everything below is [synthesis] unless tagged otherwise.
- Client sees you as an obstacle ("you're just against anything new"). Separate the person from the evidence: say you are glad they are looking for options, that researchers take it seriously, and that your role is to help them use it safely, not to forbid it. Restate their autonomy. [synthesis]
- Client asks you to endorse or choose a device. Decline the endorsement, explain why (you are not qualified to judge devices and it is not cleared for their condition), and offer B3 and B5 instead. [synthesis]
- Rupture after you raised caution. Name it ("I think what I said landed as dismissive"), take your share, and come back to their goals. Repair before more psychoeducation. [synthesis]
- Stuck: the client waits for the device instead of working in therapy. Track activity and mood over time and link changes to their own actions. Use behavioural experiments on what they can do while the device "has time to work". [synthesis]
- Non-adherence to the plan, e.g. no medical review, no eye protection. Explore barriers (cost, embarrassment, access). Problem-solve the concrete step, and record the risks you explained. [synthesis]
- Client has stopped medication or therapy elsewhere. Do not advise restarting or any change. Encourage prompt contact with the prescriber, get consent to inform them, and increase monitoring. [synthesis]
- Overwhelm or deterioration during use or a trial. Treat it as clinical information. Assess risk, update the safety plan, and inform the study team or physician the same day. Worsening depression is a listed risk in one consent form. [source: NCT04366258 consent form; synthesis]
- Eye or skin symptoms, or new neurological symptoms (word-finding difficulty, memory change). Advise urgent medical or eye review, stop the session agenda for this, and inform the team. These are listed effects in trial consent forms; retinal damage is listed as a laser risk. [source: consent forms; synthesis]
- Possible mood elevation. Ask about sleep need, energy and impulsivity, and contact the prescriber. No source opened addresses this risk for t-PBM [uncertain; synthesis].
- Disappointment or financial regret after an expensive purchase. Normalise and explore without blame. Address shame and "last hope" thinking, and screen for hopelessness. If marketing was misleading, the client may want to raise it with the seller or consumer-protection body. [synthesis]
- Over-attribution ("the light cured me") followed by stopping care. Acknowledge improvement, review the client's own changes, and plan relapse prevention as for any ending. [synthesis]
- Blinded-trial curiosity ("did I get the real one?"). Explore the meaning, but do not speculate on allocation. Refer questions about unblinding to the study team. [synthesis]
- Colleague or clinic selling devices to therapy clients. Treat it as an ethical concern (conflict of interest, claims beyond regulatory status). Discuss in supervision and follow your professional body's code. [synthesis]
Sources
Sources:
- Ji Q, Yan S, Ding J, et al. Photobiomodulation improves depression symptoms: a systematic review and meta-analysis of randomized controlled trials. Frontiers in Psychiatry, 2024
- Askalsky P, Iosifescu DV. Transcranial photobiomodulation for the management of depression: current perspectives. Neuropsychiatric Disease and Treatment, vol. 15, 2019
- Brain & Behavior Research Foundation. Team assesses safety of t-PBM… (on Cassano, Iosifescu et al., Photonics 2022), posted 23 August 2022
- Monteiro DC, et al. PHOTObiomodulation for REsistant Depression Study: an open-label pilot trial. Photobiomodulation, Photomedicine, and Laser Surgery 44(7), 2026 (abstract only)
- ClinicalTrials.gov NCT04366258. Transcranial Near Infrared Radiation and Cerebral Blood Flow in Depression: informed consent form
- ClinicalTrials.gov NCT04784416. Transcranial Photobiomodulation for Alzheimer's Disease (TRAP-AD): informed consent form
- Alzforum Therapeutics: Photobiomodulation (updated 9 May 2024)
- US FDA. General Wellness: Policy for Low Risk Devices (final guidance, January 2026)
- Troutman Pepper Locke. FDA's 2026 guidance on general wellness devices (18 March 2026)
- Kamasani A. Red light therapy's regulatory implications. MedCity News, 2026
- Peeples L. Does red-light therapy work? Here's what the science says. Scientific American (from Nature), 25 March 2026
- Helcoski R. Red light therapy: promising treatment or consumer hype? Utah Public Radio, 11 August 2026
- Woodhead M. Safety recall for acne phototherapy mask. the limbic, 26 July 2019
- Mask recall: Aussie TGA recalls Neutrogena's acne mask amid eye damage fears. CosmeticsDesign-Asia, 2019
Further reading (not drawn on): ClinicalTrials.gov NCT04569058 (photobiomodulation for autistic traits in children and adolescents with ADHD) [uncertain]. The 2025 correction to Ji et al. (DOI 10.3389/fpsyt.2025.1671091) was not reviewed. No UK, EU, Canadian or Australian regulator or guideline statement on transcranial photobiomodulation for mental health was found [uncertain].