NCT05802680 Neurocognitive Effects of Non-Invasive Near-Infrared Light Stimulation
| NCT ID | NCT05802680 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Francisco Gonzalez-Lima, PhD |
| Condition | Attention Deficit Hyperactivity Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2022-02-09 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 500 participants in total. It began in 2022-02-09 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 18 years of age or older Exclusion Criteria: * None
Contact & Investigator
Douglas W Barrett, Ph.D.
STUDY DIRECTOR
University of Texas at Austin
Frequently Asked Questions
Who can join the NCT05802680 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Attention Deficit Hyperactivity Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05802680 currently recruiting?
Yes, NCT05802680 is actively recruiting participants. Contact the research team at UTADHDExperiment@gmail.com for enrollment information.
Where is the NCT05802680 trial being conducted?
This trial is being conducted at Austin, United States.
Who is sponsoring the NCT05802680 clinical trial?
NCT05802680 is sponsored by Francisco Gonzalez-Lima, PhD. The principal investigator is Douglas W Barrett, Ph.D. at University of Texas at Austin. The trial plans to enroll 500 participants.