Neurocognitive Effects of Non-Invasive Near-Infrared Light Stimulation

NCT05802680 | Recruiting FDA Device

• 1 other identifier: 2019080005
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Continuous Performance Task

  Measure of inattention, impulsivity, sustained attention, vigilance

  Up to two months

Secondary Outcomes (1)

• Functional near-infrared spectroscopy

  Up to two months

Study Arms (4)

Sham-tPBM, non-ADHD

SHAM COMPARATOR

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-tPBM, ADHD

SHAM COMPARATOR

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

tPBM, non-ADHD

EXPERIMENTAL

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

tPBM, ADHD

EXPERIMENTAL

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

Interventions

Transcranial photobiomodulation DEVICE

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

tPBM, ADHD; tPBM, non-ADHD

Sham transcranial photobiomodulation DEVICE

Sham treatment

Sham-tPBM, ADHD; Sham-tPBM, non-ADHD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older

You may not qualify if:

• None

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

The University of Texas at Austin

Austin, Texas, 78712, United States

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Cognition Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Douglas W Barrett, Ph.D.

  University of Texas at Austin

  STUDY DIRECTOR

Central Study Contacts

Francisco Gonzalez-Lima, PhD

CONTACT

(512) 475-8497; UTADHDExperiment@gmail.com

Study Design

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

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 6, 2023
• Study Start: February 9, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 16, 2025

Record last verified: 2025-07

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, 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.

Locations

US (1)