Neurocognitive Effects of Non-Invasive Near-Infrared Light Stimulation

Inattentiveness and impulsivity in healthy adults and individuals with attention deficit hyperactivity disorder (ADHD) diminish these individuals' quality of life. Cortical hypometabolism has been hypothesized to contribute to inattentiveness in ADHD. Transcranial photobiomodulation (tPBM) is a safe and non-invasive modality for activation of the prefrontal cortex. tPBM in healthy adults has been shown to augment brain oxygenation, cognition, and mood. The cognition-enhancing effect of tPBM on sustained attention in adults with ADHD remains unstudied. The investigators will evaluate whether tPBM administration to adults with and without ADHD can improve their attention. Each participant will be screened for eighteen criteria based on the Diagnostic and Statistical Manual (DSM-IV, text revised), using the validated instrument Adult ADHD Self-Report Scale (ASRS-v1.1). Blinded participants will be randomized into (I) Active-tPBM or (II) Sham-tPBM groups. After undergoing an 8-minute administration of Sham or 1064 nm tPBM to the lateral and medial right prefrontal cortex, each participant will complete a 14-minute, computer-based Conner's continuous performance task-3 (CPT-3). The investigators will examine whether adults with and without ADHD who receive Active-tPBM improve in measures of inattention, impulsivity, sustained attention, or vigilance compared to the Sham-tPBM group. Cognitive assessments of attention like the CPT-3 may evaluate the efficacy of tPBM to increase cortical metabolism in healthy adults and individuals with conditions like ADHD. The investigators anticipate their investigation will be a starting point for more sophisticated studies that focus on the implications of tPBM on cognition.

Study Overview

• Status: Recruiting
• Conditions: Attention Deficit Hyperactivity Disorder; Cognitive Deficit; Wellness; Attention Difficulties; Attention Deficit
• Intervention / Treatment: Device: Sham transcranial photobiomodulation; Device: Transcranial photobiomodulation

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francisco Gonzalez-Lima, PhD; Phone Number: (512) 475-8497; Email: UTADHDExperiment@gmail.com

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78712
      • Recruiting
      • The University of Texas at Austin
      • Contact: Francisco Gonzalez-Lima, PhD; Email: UTADHDExperiment@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18 years of age or older

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham-tPBM, non-ADHD; 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).	Device: Sham transcranial photobiomodulation; Sham treatment
Sham Comparator: Sham-tPBM, ADHD; 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).	Device: Sham transcranial photobiomodulation; Sham treatment
Experimental: tPBM, non-ADHD; 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).	Device: Transcranial photobiomodulation; Administration of Sham or 1064 (+/- 50) nanometers tPBM
Experimental: tPBM, ADHD; 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).	Device: Transcranial photobiomodulation; Administration of Sham or 1064 (+/- 50) nanometers tPBM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuous Performance Task	Measure of inattention, impulsivity, sustained attention, vigilance	Up to two months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional near-infrared spectroscopy	Resting state and activational state using a memory task	Up to two months

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Investigators: Study Director: Douglas W Barrett, Ph.D., University of Texas at Austin

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: April 3, 2023
• First Posted (Actual): April 6, 2023

Study Record Updates

• Last Update Posted (Actual): July 16, 2025
• Last Update Submitted That Met QC Criteria: July 10, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Cognitive Dysfunction; Attention Deficit Disorder with Hyperactivity; Cognition Disorders
• Other Study ID Numbers: 2019080005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

What data will be shared? Individual participant data that underlie the results reported in this study, after deidentification (text, tables, figures, and appendices).

A data dictionary, including a description of the variables and types of data, collected for each individual, will be provided. This data will include anonymized individual participant demographic information and all outcome variables (continuous performance task, spectroscopy data).

• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication.

IPD Sharing 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, gonzalezlima@utexas.edu).

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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No