Near-Infrared Light Stimulation for ADHD

Overseen By Francisco Gonzalez-Lima, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas at Austin

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether transcranial photobiomodulation (tPBM), a special type of light therapy, can improve attention and reduce impulsivity in adults. It focuses on individuals with and without ADHD (Attention Deficit Hyperactivity Disorder) to determine if the therapy enhances brain activity and attention. Participants are randomly assigned to receive either the actual light therapy or a sham version to compare results. This trial may suit adults who struggle with focus or impulse control, regardless of a formal ADHD diagnosis. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research in light therapy for attention and impulsivity.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that transcranial photobiomodulation is safe for improving attention in adults with and without ADHD?

Research has shown that transcranial photobiomodulation (tPBM) is generally safe and well-tolerated. In earlier studies, participants experienced no negative effects on brain structure or function, and their thinking abilities remained unaffected. This suggests that tPBM does not harm the brain.

Moreover, another study found that participants handled tPBM treatments well, with no reports of negative reactions. This further supports the safety of tPBM, making it a promising option for those considering clinical trials with this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcranial photobiomodulation (tPBM) for ADHD because it offers a non-invasive alternative to the usual medications like stimulants or behavioral therapy. Unlike traditional treatments, which often involve altering brain chemistry, tPBM uses near-infrared light to stimulate brain activity directly. This approach could potentially lead to fewer side effects and provide a new option for those who don't respond well to existing therapies. Additionally, the method of using light to influence brain function is relatively novel, making it a unique avenue for ADHD treatment.

What evidence suggests that transcranial photobiomodulation is effective for improving attention in adults with ADHD?

Research has shown that using light therapy on the brain, known as transcranial photobiomodulation (tPBM), can enhance thinking skills like attention and focus. Studies with adults have found that tPBM boosts brain oxygen levels and improves mood. This technique stimulates the brain's front part, crucial for attention. While more research is needed to understand its effects on ADHD specifically, tPBM has shown promise in improving attention in similar conditions. Early results suggest that tPBM could be a safe and non-invasive way to manage ADHD symptoms. Participants in this trial will receive either tPBM or a sham treatment to evaluate its effectiveness for ADHD. ^{3 5 6 7 8}

Who Is on the Research Team?

Douglas W Barrett, Ph.D.

Principal Investigator

University of Texas at Austin

Are You a Good Fit for This Trial?

This trial is for adults over the age of 18 who may have attention issues, such as ADHD or cognitive impairment. It's designed to see if a non-invasive light therapy can help improve their attention and cognition.

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an 8-minute administration of Sham or 1064 nm tPBM followed by a 14-minute computer-based Conner's continuous performance task-3 (CPT-3)

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 months

What Are the Treatments Tested in This Trial?

Interventions

• Sham transcranial photobiomodulation
• Transcranial photobiomodulation

Trial Overview The study tests Transcranial photobiomodulation (tPBM), a type of light therapy aimed at activating the prefrontal cortex to potentially enhance brain function. Participants will be randomly assigned to receive either active tPBM or a sham (placebo) treatment.

How Is the Trial Designed?

Group I: tPBM, non-ADHD Experimental Treatment 1 Intervention

Participants with no medical diagnosis of ADHD will be exposed to the same conditions as sham participants, with the exception that the infrared light will be turned on (treated condition).

Group II: tPBM, ADHD Experimental Treatment 1 Intervention

Participants with a medical diagnosis of ADHD will be exposed to the same conditions as sham participants, with the exception that the infrared light will be turned on (treated condition).

Group III: Sham-tPBM, non-ADHD Placebo Group 1 Intervention

Participants with no medical diagnosis of ADHD will be exposed to the same conditions as treated participants, with the exception that the infrared light will be turned off (sham condition).

Group IV: Sham-tPBM, ADHD Placebo Group 1 Intervention

Participants with a medical diagnosis of ADHD will be exposed to the same conditions as treated participants, with the exception that the infrared light will be turned off (sham condition).

Transcranial photobiomodulation is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Transcranial photobiomodulation for:

• None (investigational)

Approved in Canada as Transcranial photobiomodulation for:

• None (investigational)

Approved in European Union as Transcranial photobiomodulation for:

• None (investigational)

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Published Research Related to This Trial

Photobiomodulation (PBM) uses red or near-infrared light to potentially heal and protect brain tissue affected by various disorders, including traumatic injuries, degenerative diseases, and psychiatric conditions.

Recent advancements, such as affordable LED light-emitting helmets, have made it easier to apply PBM to the brain, showing promise for cognitive enhancement and treatment of brain disorders based on pre-clinical and clinical studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shining light on the head: Photobiomodulation for brain disorders. Hamblin, MR.[2020]

In a study involving 20 individuals, those receiving near-infrared transcranial photobiomodulation (NIR t-PBM) showed a significant improvement in sexual function compared to those receiving sham therapy, indicating its potential efficacy for treating sexual dysfunction.

The improvements in sexual function were not linked to the antidepressant effects of t-PBM, suggesting that NIR t-PBM may have a distinct therapeutic action specifically for sexual dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of transcranial photobiomodulation with near-infrared light on sexual dysfunction. Cassano, P., Dording, C., Thomas, G., et al.[2020]

Transcranial laser stimulation (TLS) using near-infrared low-level laser (NIR-LLL) significantly reduced the excitability of the motor cortex in 14 healthy subjects, as measured by motor evoked potentials (MEPs) after 5 minutes of stimulation.

This reduction in motor cortex excitability was observed in 71.5% of participants and suggests that TLS may have potential therapeutic applications for conditions like stroke by modulating cortical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial application of near-infrared low-level laser can modulate cortical excitability. Konstantinović, LM., Jelić, MB., Jeremić, A., et al.[2015]

Transcranial magnetic stimulation (TMS) was found to be safe for young individuals with ADHD, as there were no serious adverse events or significant changes in auditory thresholds or neuropsychological assessments during the study involving 9 participants over 2 weeks.

While there was an overall improvement in ADHD symptoms as measured by the Clinical Global Impression-Improvement scale, the study did not find a significant difference in efficacy between the active TMS and sham treatment phases, suggesting that further research is needed to confirm its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation (TMS) in the treatment of attention-deficit/hyperactivity disorder in adolescents and young adults: a pilot study. Weaver, L., Rostain, AL., Mace, W., et al.[2022]

Transcranial magnetic stimulation (TMS) shows promise as a treatment for adolescent ADHD, with objective improvements noted in a pilot study that was randomized and sham-controlled, indicating potential efficacy for patients who do not respond to standard medications.

The review found no major adverse events associated with TMS, suggesting it is safe for use in this population; however, more extensive clinical trials are needed to confirm these findings due to the limited number of studies and participants analyzed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Magnetic Stimulation in Treatment of Adolescent Attention Deficit/Hyperactivity Disorder: A Narrative Review of Literature. Memon, AM.[2021]

Transcranial magnetic stimulation (TMS) is being explored as a promising treatment for psychiatric disorders in children and adolescents, particularly for conditions like depression, ADHD, and autism.

Despite its potential, there is a general lack of knowledge about TMS among child and adolescent psychiatrists, highlighting the need for further education and research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applications of transcranial magnetic stimulation (TMS) in child and adolescent psychiatry. Croarkin, PE., Wall, CA., Lee, J.[2011]

In a study involving 18 subjects with major depression, repetitive transcranial magnetic stimulation (rTMS) for up to 4 weeks was found to be generally safe, with no significant mean deficits in neuropsychologic function or auditory thresholds.

However, two patients experienced mild high-frequency hearing loss, indicating that while rTMS is safe for most, individual responses may vary and warrant further investigation into long-term safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a 2- to 4-week course of repetitive transcranial magnetic stimulation (rTMS) on neuropsychologic functioning, electroencephalogram, and auditory threshold in depressed patients. Loo, C., Sachdev, P., Elsayed, H., et al.[2019]

Single-pulse transcranial magnetic stimulation (sTMS) has been shown to be a low-risk technique with minimal adverse events, making it a promising option for diagnosing and treating neurological and psychiatric conditions, including migraines.

Extensive clinical experience over two decades indicates that sTMS does not cause harm to brain tissue or neurophysiological function, supporting its safety as a nonpharmacologic treatment for acute migraine headaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation for migraine: a safety review. Dodick, DW., Schembri, CT., Helmuth, M., et al.[2010]

In a study involving 49 participants with major depressive disorder (MDD), transcranial photobiomodulation (t-PBM) using low irradiance and low energy did not show significant efficacy compared to sham treatment, indicating that the current dosing may be insufficient for therapeutic effects.

The results suggest that a minimal dose threshold is necessary for t-PBM to be effective in treating MDD, similar to other neuromodulation techniques, highlighting the need for further research to determine optimal dosing parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Very Low-Level Transcranial Photobiomodulation for Major Depressive Disorder: The ELATED-3 Multicenter, Randomized, Sham-Controlled Trial. Iosifescu, DV., Norton, RJ., Tural, U., et al.[2022]

Transcranial photobiomodulation (tPBM) has shown positive effects on cognitive function in healthy adults and those with cognitive disorders, with 82.9% of the 35 studies reviewed reporting improvements, especially in patients with mild cognitive impairment and dementia.

Despite promising results, particularly in traumatic brain injury patients, the evidence is mixed, and further research is needed as only half of the studies were randomized control trials, indicating a need for more rigorous testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can transcranial photobiomodulation improve cognitive function? A systematic review of human studies. Lee, TL., Ding, Z., Chan, AS.[2023]

Transcranial photobiomodulation (tPBM) is a safe and non-invasive treatment that effectively enhances higher electrophysiological oscillations in the brain, based on a review of 10 studies involving healthy individuals aged 18-80.

While tPBM shows promise in improving brain activity, the evidence regarding its effects on lower oscillatory frequencies remains inconclusive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of transcranial photobiomodulation on electrophysiological activity of brain in healthy individuals: A scoping review. Shetty, SJ., Shetty, S., Shettigar, D., et al.[2023]

Photobiomodulation (PBM) using red and near-infrared light shows promise as a low-risk treatment for major depressive disorder (MDD), with studies indicating significant antidepressant effects comparable to traditional medications.

The proposed mechanism of action involves enhancing mitochondrial metabolism in brain cells, suggesting that PBM could improve brain function, although more research is needed to determine optimal treatment parameters and confirm its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial and systemic photobiomodulation for major depressive disorder: A systematic review of efficacy, tolerability and biological mechanisms. Caldieraro, MA., Cassano, P.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40244858/

Repetitive Transcranial Photobiomodulation Improves ... Transcranial photobiomodulation (tPBM) is a promising brain stimulation technique that may enhance cognitive function among adults with ADHD. Objectives: We ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04569058

NCT04569058 | Transcranial Photobiomodulation Therapy ... An open label trial to assess the safety and efficacy of transcranial photobiomodulation (tPBM) in improving autistic traits in ADHD youth. Detailed Description.

3. liebertpub.com liebertpub.com/doi/full/10.1089/photob.2025.0008?doi=10.1089/photob.2025.0008

A 4-Week Follow-Up Study | Photobiomodulation ... A conceptual model of child psychopathology: Implications for understanding attention deficit hyperactivity disorder and treatment efficacy.

4. medrxiv.org medrxiv.org/content/10.1101/2025.09.18.25335086v1.full-text

Transcranial Light Stimulation Improves Selective Attention ... Low frequency repetitive transcranial magnetic stimulation in children with attention deficit/hyperactivity disorder. Preliminary results.

5. scirp.org scirp.org/journal/paperinformation?paperid=119187

Efficacy of Photobiomodulation for Attention Deficit ... The case studies presented here, suggest that LLLT can provide alleviation of these symptoms, with some improvement reported after just a single treatment.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9139753/

Transcranial Photobiomodulation for the Treatment of ... Importantly, the results of this retrospective study suggested that tPBM is safe, since all participants tolerated the stimulations well, even ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X24001955

Transcranial low-level laser stimulation in the near-infrared ... Our data indicate that 1064 nm laser tPBM does not induce adverse effects on brain structure or function, nor does it impair cognitive abilities. tPBM is safe ...

8. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-024-01351-8

Devices used for photobiomodulation of the brain—a ... Studies that use these parameters showed safety, negligible heat, and no physical damage [20, 29]. One study reported that the neuromodulation ...