Recruiting

Near-Infrared Light

Sponsor:

Francisco Gonzalez-Lima, PhD

Code:

NCT05802680

Conditions

Attention Deficit Hyperactivity Disorder

Attention Difficulties

Attention Deficit

Cognitive Deficit

Wellness

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Transcranial photobiomodulation

Sham transcranial photobiomodulation

Study Details

Brief summary:

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.

Conditions

Attention Deficit Hyperactivity Disorder

Attention Difficulties

Attention Deficit

Cognitive Deficit

Wellness

Study ID

NCT05802680

Start date

Feb 9, 2022

Status verified date

Jul, 2025

Completion date

Feb 1, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 18 years of age or older

Exclusion Criteria:

  • None

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

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).

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).

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).

Interventions

Transcranial photobiomodulation

Administration of Sham or 1064 (+/- 50) nanometers tPBM

Sham transcranial photobiomodulation

Sham treatment

Primary outcome measure

  • Continuous Performance Task [ Time Frame: Up to two months ]

Central Contacts and Locations

Central contacts

Francisco Gonzalez-Lima, PhD

(512) 475-8497UTADHDExperiment@gmail.com

Locations

The University of Texas at Austin

Recruiting

Austin, Texas, United States, 78712

Contacts

Francisco Gonzalez-Lima, PhD

UTADHDExperiment@gmail.com

More Information

Sponsor

Francisco Gonzalez-Lima, PhD

Last update posted

Jun 22, 2026

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Francisco Gonzalez-Lima, PhD on 2026-06-22.