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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new light therapy, Transcranial Photobiomodulation, to determine its safety and effectiveness for children and teens with ADHD who also exhibit signs of autism. The treatment involves shining a special type of near-infrared light on the brain. It targets young people aged 9 to 17 diagnosed with ADHD and moderate autism traits that impact daily life. Participants must have access to a computer with a camera and internet connection for the study. As an unphased trial, this study provides a unique opportunity for participants to contribute to groundbreaking research in a novel treatment area.

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 prior data suggests that transcranial photobiomodulation is safe for ADHD youth?

Research has shown that transcranial photobiomodulation (tPBM) is a promising and well-tolerated treatment. It is non-invasive, meaning it doesn't involve surgery or entering the body. This treatment uses near-infrared light to target the brain, and studies have found it effective for various brain conditions.

In earlier research, tPBM reduced long-term brain issues in mice with brain injuries, suggesting it can support brain health. Although this data comes from animal studies, it boosts confidence in the treatment's safety. Additionally, researchers are testing tPBM for other brain conditions in humans, focusing on safety and side effects.

Overall, the non-invasive nature of tPBM and its increasing use in brain therapies suggest it is generally well-tolerated. However, as with any treatment, discussing potential risks with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcranial Photobiomodulation is unique because it uses near-infrared light to target the forebrain, offering a noninvasive approach to managing ADHD. Unlike traditional treatments that often rely on medications like stimulants and non-stimulants to manage symptoms, this method directly interacts with brain function using light. Researchers are excited about this treatment because it could offer a drug-free alternative, potentially reducing side effects and providing a more natural way to improve attention and behavior in individuals with ADHD.

What evidence suggests that transcranial photobiomodulation is effective for improving autistic traits in ADHD?

Research has shown that transcranial photobiomodulation (tPBM), which participants in this trial will receive, could be a promising treatment for brain-related conditions. tPBM uses near-infrared light to enhance brain function. Studies have found that it aids in healing and protecting potentially damaged brain tissue. It is non-invasive, requiring no surgery. Although specific data for ADHD is not yet available, the technology has demonstrated positive effects in other brain disorders, suggesting potential benefits. Early findings indicate it could improve certain brain functions, making it worth exploring for conditions like ADHD. ^{1 2 6 7 8}

Who Is on the Research Team?

T. Atilla Ceranoglu, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.230999

Effects of Low-Level Light Therapy on Resting-State ... Low-level light therapy (LLLT), also known as photobiomodulation, is an emerging therapy based on the transcranial or intranasal delivery of ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2214647416300381

Shining light on the head: Photobiomodulation for brain ... Photobiomodulation (PBM) describes the use of red or near-infrared light to stimulate, heal, regenerate, and protect tissue that has either been injured, ...

3. mdpi.com mdpi.com/2073-4409/13/11/966

Photobiomodulation Therapy on Brain: Pioneering an ... Photobiomodulation (PBM) therapy on the brain employs red to near-infrared (NIR) light to treat various neurological and psychological disorders.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10840571/

Transcranial photobiomodulation for brain diseases: review of ... Transcranial photobiomodulation (tPBM) is a promising technology for treating brain diseases, due to its effectiveness, non-invasiveness, and affordability.

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

Devices used for photobiomodulation of the brain—a ... A systematic review was conducted to determine the trends in devices and parameters used for brain photobiomodulation (PBM).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4550182/

Treatments for traumatic brain injury with emphasis on ... Near infrared transcranial laser therapy applied at various modes to mice following traumatic brain injury significantly reduces long-term neurological deficits ...

7. occupationaltherapybrisbane.com.au occupationaltherapybrisbane.com.au/red-light-therapy-for-neurological-conditions-explained/

Red Light Therapy For Neurological Conditions Explained Red light therapy (RLT) is a noninvasive treatment that uses visible red light and or near infrared (not visible) light to stimulate the body.

8. link.springer.com link.springer.com/chapter/10.1007/978-3-031-36231-6_1

Introduction Photobiomodulation (PBM), previously known as low-level light/laser therapy (LLLT), refers to the non-thermal application of the non-ionizing ...