Light Therapy for ADHD

Overseen By Chloe Hutt Vater, BA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Light-activated drugs, Psychotropics

Disqualifiers: Impaired intellect, Serious conditions, Implants, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

38 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a light-based treatment called tPBM on youth with ADHD and autistic traits. The treatment aims to improve brain function by boosting energy in brain cells. Researchers hope it will help with social and cognitive issues that current ADHD medications do not address.

Will I have to stop taking my current medications?

The trial requires that if you are on a psychotropic medication, your dose must be stable for at least 4 weeks before starting the study treatment. If your medication dose is not stable, you may need to adjust it before participating.

What data supports the effectiveness of the treatment Transcranial Photobiomodulation for ADHD?

Research shows that transcranial low-level light therapy (tLLLT) has been effective in improving memory and learning in animal models of traumatic brain injury and has shown potential benefits for depression and anxiety in rats. These findings suggest that tLLLT could have positive effects on brain function, which might be relevant for ADHD treatment. ^{1 2 3 4 5}

Is light therapy safe for humans?

Research on light therapy, also known as transcranial photobiomodulation, has been conducted for various conditions like stroke, depression, and brain injury. Studies in animals and some human trials suggest it is generally safe, with no major side effects reported. ^{1 3 4 5 6}

How does light therapy for ADHD differ from other treatments?

Light therapy for ADHD, known as transcranial photobiomodulation, is unique because it uses red or near-infrared light to stimulate brain cells, potentially improving brain function without the side effects often associated with medications. This treatment is non-invasive and works by enhancing cellular energy production and activating protective genes, which is different from traditional ADHD medications that typically alter neurotransmitter levels. ^{1 3 4 5 7}

Research Team

T. Atilla Ceranoglu, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for boys and girls aged 9-17 with ADHD and moderate to severe autism traits. They must understand the study, agree to its procedures, have stable internet access for remote participation, and not be on unstable psychotropic meds or have certain skin conditions or head implants.

Inclusion Criteria

Participants must have access to a computer with camera and broadband internet connection

I am willing and able to follow all study requirements and self-administer treatment as needed.

Participants must understand the nature of the study. Participants must sign an Institutional Review Board-approved informed consent form before initiation of any study procedures

Exclusion Criteria

I have not used any light-activated drugs in the last 14 days.

You have any kind of implant in your head, like a stent or a valve.

My mental health medication dose has been stable for less than 4 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcranial photobiomodulation (tPBM) therapy daily for 8 weeks at home, with regular telemedicine check-ins to monitor safety and efficacy.

8 weeks

Regular telemedicine visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Transcranial Photobiomodulation

Trial Overview The trial tests transcranial photobiomodulation (tPBM) therapy's safety and effectiveness in reducing autistic traits among children and adolescents with ADHD. It's an open-label study where all participants receive the treatment.

Participant Groups

Group I: Transcranial Photobiomodulation Experimental Treatment 1 Intervention

Transcranial Photobiomodulation--a noninvasive intervention in which near-infrared light (850 nanometer) is applied to forebrain.

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

Approved in United States as Transcranial Photobiomodulation for:

• Not approved for any indication; under investigation for Alzheimer's Disease and Mild Cognitive Impairment

Approved in European Union as Transcranial Photobiomodulation for:

• Not approved for any indication; under investigation for Alzheimer's Disease and Mild Cognitive Impairment

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Findings from Research

Near-infrared laser therapy (NIRLT) is being studied as a potential treatment for acute ischemic stroke patients in a pivotal phase III trial (NEST-3), focusing on its neuroreparatory and neuroprotective effects.

The review discusses the theoretical background and experimental studies supporting NIRLT, indicating its promise in clinical applications for stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Near-infrared laser treatment of acute stroke: from bench to bedside]. Schellinger, PD., Köhrmann, M.[2021]

Transcranial low-level laser therapy (LLLT) shows promise as a treatment for traumatic brain injury (TBI) by promoting neuroprotection, reducing inflammation, and stimulating neurogenesis, based on both animal studies and limited clinical reports.

In studies conducted on mice, specific parameters such as a pulsed frequency of 10 Hz and laser wavelengths of 660 and 810 nm were found to be particularly effective in improving neurological performance and cognitive functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial low level laser (light) therapy for traumatic brain injury. Huang, YY., Gupta, A., Vecchio, D., et al.[2023]

Transcranial photobiomodulation (PBM) using NIR light has shown promising results in treating traumatic brain injury (TBI) in mice, leading to improved memory and learning, as well as increased neuroprogenitor cells and synaptogenesis in the brain.

The mechanism of action involves photon absorption in mitochondria, which activates signaling pathways that enhance protective gene expression, suggesting that PBM could have broader applications for various neurological conditions beyond TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation and the brain: a new paradigm. Hennessy, M., Hamblin, MR.[2020]

Low-level laser therapy (LLLT) shows promise as a treatment for traumatic brain injury (TBI) by promoting neurogenesis, reducing inflammation, and providing neuroprotection, as supported by both animal and clinical trials.

In studies conducted on mice, the most effective treatment involved pulsed laser irradiation at 10 Hz and specific wavelengths of 660 and 810 nm, while excessive treatment regimens (like 14 days of daily applications) were found to be counterproductive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Low-Level Laser (Light) Therapy for Brain Injury. Thunshelle, C., Hamblin, MR.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Near-infrared laser treatment of acute stroke: from bench to bedside]. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Transcranial low level laser (light) therapy for traumatic brain injury. [2023]

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

Therapeutic effects of 10-HzPulsed wave lasers in rat depression model: A comparison between near-infrared and red wavelengths. [2018]

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

Pulsed light irradiation improves behavioral outcome in a rat model of chronic mild stress. [2021]

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

Photobiomodulation and the brain: a new paradigm. [2020]

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

Transcranial Low-Level Laser (Light) Therapy for Brain Injury. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Photobiomodulation using low-level laser therapy (LLLT) for patients with chronic traumatic brain injury: a randomized controlled trial study protocol. [2019]