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Device

Transcranial Photobiomodulation for Attention Deficit Hyperactivity Disorder (ADHD)

N/A

Recruiting

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 8

Awards & highlights

Study Summary

This trial is testing whether a light therapy called transcranial photobiomodulation (tPBM) is safe and effective in improving autistic traits in kids with ADHD.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Secondary outcome measures

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

Safety (The Transcranial Photobiomodulation Self-Report Questionnaire)

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,929 Previous Clinical Trials

13,198,245 Total Patients Enrolled

59 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)

8,479 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

T. Atilla Ceranoglu, MDPrincipal InvestigatorMassachusetts General Hospital

1 Previous Clinical Trials

54 Total Patients Enrolled

Media Library

Transcranial Photobiomodulation (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04569058 — N/A

Attention Deficit Hyperactivity Disorder (ADHD) Research Study Groups: Transcranial Photobiomodulation

Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial 2023: Transcranial Photobiomodulation Highlights & Side Effects. Trial Name: NCT04569058 — N/A

Transcranial Photobiomodulation (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04569058 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I be enrolled in this medical experiment?

"Patients between the ages of nine and seventeen with an autism or early infantile diagnosis could potentially qualify for this trial. A total of sixty participants are being sought out."

Answered by AI

Are juvenile individuals being granted access to this research?

"According to this trial's entry requirements, the eligible age range is 9-17. Clinicialtrials.gov hosts 277 studies for individuals underage and 71 trials that accommodate those aged 65 and up."

Answered by AI

What is the uppermost cap of participants taking part in this experiment?

"Affirmative, the information hosted on clinicaltrials.gov reveals that this medical experiment is actively recruiting volunteers and has been since January 14th 2021. As of November 30th 2022, 60 people are required to partake in the study at a single site."

Answered by AI

Is this research currently open for recruitment?

"According to the information hosted on clinicaltrials.gov, this research endeavour is still actively recruiting suitable participants. The trial was first published in January 2021 and underwent its last update in November 2022."

Answered by AI