What side effects are associated with this type of intervention?

Common treatments for ADHD include stimulant medications (e.g., methylphenidate and amphetamines) and non-stimulant medications (e.g., atomoxetine and guanfacine). Stimulant medications can cause side effects such as insomnia, decreased appetite, weight loss, increased heart rate, and potential for abuse. Non-stimulant medications may cause side effects like fatigue, dry mouth, dizziness, and mood swings. For treatments similar to Transcranial Photobiomodulation (tPBM), which involves light stimulation, side effects are generally minimal but can include mild headaches, dizziness, and skin irritation at the site of light application. More research is needed to fully understand the long-term effects of tPBM.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of ADHD, primarily focusing on stimulant medications like methylphenidate and amphetamines, as well as non-stimulant options like atomoxetine and guanfacine. While these medications target neurotransmitter activity to alleviate symptoms, neuromodulation techniques such as Transcranial Magnetic Stimulation (TMS) have also been explored, though not yet widely approved for ADHD. TMS, which uses magnetic fields to stimulate brain activity, shares a similar mechanism to Transcranial Photobiomodulation (tPBM), which uses light for neural modulation. However, specific FDA approvals for tPBM in ADHD treatment are not yet established.

What other types of research exist?

Promising, novel alternatives to Transcranial Photobiomodulation (tPBM) for ADHD patients include: 1) Transcutaneous supraorbital nerve stimulation, which has shown efficacy in reducing pain intensity in migraine patients and could potentially modulate neural circuits in ADHD. 2) Remote electrical neuromodulation, which uses nonpainful electrical skin stimulation and has shown positive results in reducing acute migraine pain, suggesting potential benefits for ADHD symptoms. Both methods are non-invasive and have demonstrated safety and efficacy in clinical trials for other conditions.

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Device

Light Therapy for ADHD

N/A

Waitlist Available

Led By T. Atilla Ceranoglu, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants are willing and able to cooperate with all tests, examinations and demonstrate ability to appropriately administer the study treatment required by the protocol

Male or female participants between 9 and 17 years of age (inclusive)

Must not have

The subject has a significant skin condition at the procedure sites (i.e., hemangioma, scleroderma, psoriasis, rash, open wound or tattoo)

Impaired intellectual capacity (clinically determined)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 8

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not detailed here but may include discomfort at the treatment site or light sensitivity due to tPBM. Participants should not currently use any light-sensitive medications as these could increase risk of side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am between 9 and 17 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a skin condition like a rash or tattoo where the procedure will be done.

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I have been diagnosed with impaired intellectual capacity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy-Attention Deficit Hyperactivity Disorder (Attention Deficit Hyperactivity Disorder Symptom Checklist)

Efficacy-Autism Spectrum Disorder (Social Responsiveness Scale-2)

Secondary study objectives

Number of Participants that Report Adverse Events (Clinician-Rated Treatment Emergent Adverse Events Log)

Safety (The Transcranial Photobiomodulation Self-Report Questionnaire)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Transcranial PhotobiomodulationExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcranial Photobiomodulation

2021

N/A

~40

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for ADHD include medications, cognitive-behavioral therapy (CBT), and neuromodulation techniques like transcranial photobiomodulation (tPBM). Medications such as stimulants increase neurotransmitter levels to enhance attention and control impulsivity. CBT focuses on teaching skills to manage symptoms and improve emotional regulation. Neuromodulation techniques, including tPBM, use light to stimulate brain activity and modulate neural circuits, potentially improving ADHD symptoms. Understanding these mechanisms helps tailor treatments to individual needs, enhancing effectiveness and quality of life for ADHD patients.

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