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

Trial Summary

What is the purpose of this trial?

This trial tests whether a light-based brain treatment can help improve attention in adults with and without ADHD. The treatment aims to boost brain activity in the prefrontal cortex. Participants' attention will be measured at different points during the study.

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 data supports the idea that Near-Infrared Light Stimulation for ADHD is an effective treatment?

The available research does not provide specific data supporting the effectiveness of Near-Infrared Light Stimulation for ADHD. However, studies have explored its use for other brain-related conditions like major depressive disorder and cognitive function. These studies suggest that the treatment might have potential benefits for brain disorders, but there is no direct evidence for its effectiveness in treating ADHD compared to other alternative treatments. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Near-Infrared Light Stimulation for ADHD?

Research suggests that transcranial photobiomodulation (tPBM) using near-infrared light may help with various brain disorders, including depression and cognitive function. This treatment involves shining light on the head to stimulate and protect brain tissue, and it has shown potential benefits for conditions like depression and cognitive enhancement, which might suggest possible benefits for ADHD as well. ^{1 2 3 4 5}

What safety data exists for near-infrared light stimulation for ADHD?

The provided research does not contain specific safety data for near-infrared light stimulation or transcranial photobiomodulation (tPBM) for ADHD. The studies focus on transcranial magnetic stimulation (TMS), which is a different treatment modality. Therefore, no relevant safety data for near-infrared light stimulation for ADHD is available in the provided research. ^{6 7 8 9 10}

Is Transcranial photobiomodulation a promising treatment for ADHD?

Transcranial photobiomodulation (tPBM) is a promising treatment because it uses safe, non-invasive light therapy to stimulate brain activity. It has shown potential benefits for various brain disorders, including depression and cognitive enhancement, suggesting it could also help with ADHD. ^{1 2 3 11 12}

How is transcranial photobiomodulation (tPBM) different from other ADHD treatments?

Transcranial photobiomodulation (tPBM) is unique because it uses near-infrared light to stimulate brain tissue, which is a non-invasive and low-risk approach compared to traditional ADHD treatments like medication. Unlike drugs that alter brain chemistry, tPBM aims to enhance brain function by directly modulating neural activity through light exposure. ^{1 2 3 11 12}

Research Team

Douglas W Barrett, Ph.D.

Principal Investigator

University of Texas at Austin

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

Exclusion Criteria

Not applicable.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Very Low-Level Transcranial Photobiomodulation for Major Depressive Disorder: The ELATED-3 Multicenter, Randomized, Sham-Controlled Trial. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

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

3. Netherlands pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Effects of transcranial photobiomodulation with near-infrared light on sexual dysfunction. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Can transcranial photobiomodulation improve cognitive function? A systematic review of human studies. [2023]

6. United States 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. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. England pubmed.ncbi.nlm.nih.gov

Applications of transcranial magnetic stimulation (TMS) in child and adolescent psychiatry. [2011]

9. United States 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. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation for migraine: a safety review. [2010]

11. United States pubmed.ncbi.nlm.nih.gov

Transcranial application of near-infrared low-level laser can modulate cortical excitability. [2015]

12. Scotland pubmed.ncbi.nlm.nih.gov

Effect of transcranial photobiomodulation on electrophysiological activity of brain in healthy individuals: A scoping review. [2023]