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NCT Number: NCT05802680

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas at Austin

Austin, Texas, 78712, United States

Location status: Recruiting

Location contact

Francisco Gonzalez-Lima, PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age or older

Exclusion criteria

  • None

Treatment and study plan

transcranial photobiomodulation

Device

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

sham transcranial Photobiomodulation

Device

Sham treatment

Primary outcomes

  1. Continuous Performance Task

    Time frame: Up to two months

    Measure of inattention, impulsivity, sustained attention, vigilance

Secondary outcomes

  1. Functional near-infrared spectroscopy

    Time frame: Up to two months

    Resting state and activational state using a memory task

Study contacts

Contact information is provided by the study sponsor or research team.

Francisco Gonzalez-Lima, PhD

CONTACT

[email protected]

(512) 475-8497

Sponsors and collaborators

Lead sponsor

Francisco Gonzalez-Lima, PhD

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Apr 6, 2023
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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