Effects of Transcranial Photobiomodulation in ADHD

NCT07203092 | Recruiting FDA Device

• 1 other identifier: STUDY00007909
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators have previously shown that non-invasive methods of brain stimulation such as the administration of transcranial infrared light to the prefrontal cortex (PFC) can result in improvements to cognition and emotion as well as brain oxygenation. This method is called transcranial photobiomodulation (tPBM). The investigators hypothesize that tPBM can improve cognition and brain oxygenation in adults with attention deficit hyperactivity disorder (ADHD). The investigators will investigate the effects of repeated tPBM sessions on cognitive functioning in adults with ADHD. Specifically, the investigators hypothesize that participants that receive tPBM will show improvements in response control, sustained attention, and working memory, as well as improvements in prefrontal hemodynamics and a reduction in ADHD symptoms.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD; transcranial photobiomodulation; cognition; prefrontal cortex; brain metabolism

Outcome Measures

Primary Outcomes (3)

• Performance on the Continuous Performance Task

  The Continuous Performance Task is a widely-used cognitive measure to evaluate sustained attention, vigilance, and response control. Participants respond to letters presented on a computer screen and inhibit their responses to the letter X. There is no score on a scale. An increase in Correct Rejections on CPT = better inhibition = better outcome of treatment.

  1. Pre-Treatment: Baseline (Visit 1). 2. Post-treatment: Two weeks later (Visit 3).

• Prefrontal oxygenation (functional near-infrared spectroscopy)

  Participants will wear a head-mounted functional near-infrared spectroscopy device that records changes in the concentrations of oxygenated hemoglobin potentially resulting from the treatment.

  1. Pre-Treatment: Baseline (Visit 1). 2. Post-treatment: Two weeks later (Visit 3).

• Scores on the Adult ADHD Self-Report Scale (ASRS) questionnaire

  The ASRS is an 18-question self-assessment tool created by the World Health Organization (WHO) which evaluates symptom severity of ADHD. Minimum score=18; maximum score=90; high score = more ADHD symptoms; lower score after treatment = better outcome.

  1. Pre-Treatment: Baseline (Visit 1). 2. Post-treatment: Two weeks later (Visit 3). 3. Follow-up: Four weeks later (Online).

Study Arms (2)

Active transcranial photobiomodulation

ACTIVE COMPARATOR

Participants in this arm will receive active transcranial photobiomodulation to the forehead, targeting prefrontal cortex.

Device: Active transcranial photobiomodulation

Sham transcranial photobiomodulation

SHAM COMPARATOR

Participants in this arm will undergo this same procedure as the active group, but with no 1064-nm light emitted by the device.

Device: Sham transcranial photobiomodulation

Interventions

Active transcranial photobiomodulation DEVICE

Active transcranial photobiomodulation to the forehead targeting prefrontal cortex involves administration of 1064-nm light delivered via laser with a 4 centimeter beam diameter and 250 mW/cm2 power density for 8 minutes per treatment.

Active transcranial photobiomodulation

Sham transcranial photobiomodulation DEVICE

Identical procedure as active group, but without 1064-nm light emitted by the device.

Sham transcranial photobiomodulation

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• English-speaking
• Adults of any sex
• Age range: 18-44 years
• Any ethnic/racial background
• Medical history of ADHD
• Participants may either be on a stable ADHD medication regimen (with no changes within two weeks prior to the study) or not taking medication.

You may not qualify if:

• Currently pregnancy
• Any sham or active photobiomodulation treatment within the past five weeks.

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

The University of Texas at Austin

Austin, Texas, 78701, United States

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Francisco Gonzalez-Lima, Ph.D.

CONTACT

512-537-5257; UTBrainProject@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: October 2, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: The raw data will be made available by the researchers upon reasonable request by any qualified doctoral researcher (PhD, MD). They will be granted access by contacting the corresponding author/principal investigator (F. Gonzalez-Lima, utbrainproject@gmail.com). It will be made available to qualified researchers whose proposed use of the data has been approved by an independent review committee (Institutional Review Board) identified for the purpose of individual participant data meta-analysis. Proposals may be submitted up to 36 months following article publication. After 36 months, the data will be available in our University's shared network drive, but without investigator support other than deposited metadata.

Locations

US (1)