Effects of Transcranial Photobiomodulation in ADHD

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified April 2026 by University of Texas at Austin
Sponsor
University of Texas at Austin
Information Provided by (Responsible Party)
Francisco Gonzalez-Lima, PhD
Clinicaltrials.gov Identifier
NCT07203092
Other Study ID Numbers:
STUDY00007909
First Submitted
September 14, 2025
First Posted
October 1, 2025
Last Update Posted
May 10, 2026
Last Verified
April 2026

ClinicalTrials.gov processed this data on May 2026Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

This will be a double-blind, sham-controlled study to evaluate the neurobehavioral and PFC neurometabolic effects of repeated tPBM sessions in adults with ADHD. Adults with a history of medically-diagnosed ADHD will be recruited. Participants will be randomized to two arms: (1) active tPBM or (2) sham tPBM. All participants will complete three in-person sessions and one remote follow-up visit conducted online. Participant will receive three weekly sessions of tPBM targeting the PFC using a 1064 nm laser. Cognitive performance will be assessed using the continuous performance task and 2-back task at baseline and after the final tPBM session. The investigators predict that participants receiving active tPBM will show improvements in sustained attention, impulse control, and working memory. Functional near-infrared spectroscopy recordings, collected at baseline and post-treatment, will be used to evaluate changes in PFC hemodynamic response and network interactions (functional connectivity). The investigators predict that active tPBM will enhance the PFC hemodynamic response and strengthen network interactions across prefrontal subregions. Lastly, ADHD symptomatology will be assessed using the Adult ADHD Self-Report Scale at baseline, post-treatment, and at a four-week follow-up after tPBM. The investigators predict that participants receiving active tPBM will report progressive reductions in ADHD symptoms across time points.

Condition or DiseaseIntervention/Treatment
Attention Deficit Hyperactivity Disorder
Device: Active transcranial photobiomodulationDevice: Sham transcranial photobiomodulation

Study Design

Study TypeInterventional
Actual Enrollment140 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleEffects of Transcranial Photobiomodulation on Cognition and Brain Metabolism in Adults With ADHD
Study Start DateAugust 31, 2025
Actual Primary Completion Date1yr 5mos from now
Actual Study Completion Date1yr 6mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Active transcranial photobiomodulation
Participants in this arm will receive active transcranial photobiomodulation to the forehead, targeting prefrontal cortex.
Device: Active transcranial photobiomodulation
Active transcranial photobiomodulation to the forehead targeting prefrontal cortex involves administration of 1064-nm light delivered via laser with a 4 centimeter beam diameter and 250 mW/cm2 power density for 8 minutes per treatment.
Sham transcranial photobiomodulation
Participants in this arm will undergo this same procedure as the active group, but with no 1064-nm light emitted by the device.
Device: Sham transcranial photobiomodulation
Identical procedure as active group, but without 1064-nm light emitted by the device.

Outcome Measures

Primary Outcome Measures
  1. Performance on the Continuous Performance Task
    The Continuous Performance Task is a widely-used cognitive measure to evaluate sustained attention, vigilance, and response control. Participants respond to letters presented on a computer screen and inhibit their responses to the letter X. There is no score on a scale. An increase in Correct Rejections on CPT = better inhibition = better outcome of treatment.
  2. Prefrontal oxygenation (functional near-infrared spectroscopy)
    Participants will wear a head-mounted functional near-infrared spectroscopy device that records changes in the concentrations of oxygenated hemoglobin potentially resulting from the treatment.
  3. Scores on the Adult ADHD Self-Report Scale (ASRS) questionnaire
    The ASRS is an 18-question self-assessment tool created by the World Health Organization (WHO) which evaluates symptom severity of ADHD. Minimum score=18; maximum score=90; high score = more ADHD symptoms; lower score after treatment = better outcome.

Eligibility Criteria

Ages Eligible for Study(Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
English-speaking
Adults of any sex
Age range: 18-44 years
Any ethnic/racial background
Medical history of ADHD
Participants may either be on a stable ADHD medication regimen (with no changes within two weeks prior to the study) or not taking medication.
Exclusion Criteria
Currently pregnancy
Any sham or active photobiomodulation treatment within the past five weeks.

Contacts and Locations

Sponsors and CollaboratorsUniversity of Texas at Austin
Locations
The University of Texas at Austin | Austin Texas, United States, 78701