Neurocognitive Effects of Non-Invasive Near-Infrared Light Stimulation

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

Neurocognitive Effects of Non-Invasive Near-Infrared Light Stimulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05802680
• Other study ID #: 2019080005
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2022
• Est. completion date: February 1, 2025

Study information

• Verified date: July 2023
• Source: University of Texas at Austin
• Contact: Francisco Gonzalez-Lima, PhD
• Phone: (512) 475-8497
• Email: UTADHDExperiment[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: February 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Attention Deficit
• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Cognition Disorders
• Cognitive Deficit
• Cognitive Dysfunction
• Wellness

Intervention

Device:
• Transcranial photobiomodulation
Administration of Sham or 1064 (+/- 50) nanometers tPBM
• Sham transcranial photobiomodulation
Sham treatment

Locations

Country	Name	City	State
United States	The University of Texas at Austin	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continuous Performance Task	Measure of inattention, impulsivity, sustained attention, vigilance	Up to two months
Secondary	Functional near-infrared spectroscopy	Resting state and activational state using a memory task	Up to two months