What side effects are associated with this type of intervention?

Common treatments for Attention Deficit Disorder (ADD) include medications like methylphenidate and non-invasive neuromodulation techniques such as Transcranial Magnetic Stimulation (TMS) and Transcranial Photobiomodulation (tPBM). Known side effects of these treatments can vary. For medications like methylphenidate, side effects often include insomnia, decreased appetite, weight loss, and increased heart rate. Neuromodulation techniques like TMS and tPBM are generally well-tolerated but can cause mild side effects such as headaches, scalp discomfort, and lightheadedness. Serious side effects are rare but can include seizures in susceptible individuals. Overall, these treatments are considered safe with proper medical supervision.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Attention Deficit Disorder (ADD), including stimulants like methylphenidate and non-stimulants such as atomoxetine. These medications primarily target neurotransmitter systems to improve attention and reduce hyperactivity and impulsivity. While Transcranial Photobiomodulation (tPBM) is being studied for its potential to enhance prefrontal cortex activity and improve attention, it has not yet received FDA approval for ADD treatment. Current FDA-approved treatments focus on pharmacological approaches rather than neuromodulation techniques like tPBM.

What other types of research exist?

Promising, novel alternatives to Transcranial Photobiomodulation for Attention Deficit Disorder patients include: 1) Transcranial Magnetic Stimulation (TMS), which has shown efficacy in improving cognitive functions and reducing symptoms in various neuropsychiatric conditions. 2) Transcutaneous Supraorbital Nerve Stimulation, which has been effective in reducing pain intensity in migraine patients and may have potential applications in ADD. 3) Remote Electrical Neuromodulation, which involves nonpainful electrical skin stimulation and has shown positive results in reducing acute migraine pain, suggesting potential benefits for ADD.

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Behavioural Intervention

Near-Infrared Light Stimulation for ADHD

N/A

Recruiting

Research Sponsored by University of Texas at Austin

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to two months

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since tPBM is non-invasive and has been considered safe in previous studies, significant side effects are not expected. However, individual experiences may vary.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to two months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to two months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to two months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Continuous Performance Task

Secondary study objectives

Functional near-infrared spectroscopy

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: tPBM, non-ADHDExperimental Treatment1 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, ADHDExperimental Treatment1 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-ADHDPlacebo Group1 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, ADHDPlacebo Group1 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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcranial photobiomodulation

2018

N/A

~40

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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 Attention Deficit Disorder (ADD) that involve neuromodulation, such as Transcranial Photobiomodulation (tPBM) and Transcranial Magnetic Stimulation (TMS), work by stimulating the prefrontal cortex to enhance brain function. These treatments increase cortical metabolism and oxygenation, which is vital for improving attention, impulse control, and working memory—key areas affected in ADD. By targeting the prefrontal cortex, these therapies aim to alleviate symptoms and improve cognitive deficits, offering a tailored approach to managing ADD.

Enhancing attention in neurodegenerative diseases: current therapies and future directions.

Find a Location

Who is running the clinical trial?

University of Texas at AustinLead Sponsor

370 Previous Clinical Trials

82,686 Total Patients Enrolled

Douglas W Barrett, Ph.D.Study DirectorUniversity of Texas at Austin

Media Library

Transcranial photobiomodulation (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05802680 — N/A

Attention Deficit Disorder Research Study Groups: Sham-tPBM, non-ADHD, tPBM, non-ADHD, tPBM, ADHD, Sham-tPBM, ADHD

Attention Deficit Disorder Clinical Trial 2023: Transcranial photobiomodulation Highlights & Side Effects. Trial Name: NCT05802680 — N/A

Transcranial photobiomodulation (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05802680 — N/A

Attention Deficit Disorder Patient Testimony for trial: Trial Name: NCT05802680 — N/A

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