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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05802680
Other study ID # 2019080005
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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