Recruiting

tPBM

Sponsor:

Francisco Gonzalez-Lima, PhD

Code:

NCT07203092

Conditions

Attention Deficit Hyperactivity Disorder

Eligibility Criteria

Sex: All

Age: 18 - 44

Healthy Volunteers: Not accepted

Interventions

Active transcranial photobiomodulation

Sham transcranial photobiomodulation

Study Details

Brief summary:

The investigators have previously shown that non-invasive methods of brain stimulation such as the administration of transcranial infrared light to the prefrontal cortex (PFC) can result in improvements to cognition and emotion as well as brain oxygenation. This method is called transcranial photobiomodulation (tPBM).

The investigators hypothesize that tPBM can improve cognition and brain oxygenation in adults with attention deficit hyperactivity disorder (ADHD). The investigators will investigate the effects of repeated tPBM sessions on cognitive functioning in adults with ADHD. Specifically, the investigators hypothesize that participants that receive tPBM will show improvements in response control, sustained attention, and working memory, as well as improvements in prefrontal hemodynamics and a reduction in ADHD symptoms.

Conditions

Attention Deficit Hyperactivity Disorder

Study ID

NCT07203092

Start date

Sep 1, 2025

Status verified date

May, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 44

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active transcranial photobiomodulation

Participants in this arm will receive active transcranial photobiomodulation to the forehead, targeting prefrontal cortex.

sham comparator: 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.

Interventions

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

Identical procedure as active group, but without 1064-nm light emitted by the device.

Primary outcome measure

  • Performance on the Continuous Performance Task [ Time Frame: 1. Pre-Treatment: Baseline (Visit 1). 2. Post-treatment: Two weeks later (Visit 3). ]
  • Prefrontal oxygenation (functional near-infrared spectroscopy) [ Time Frame: 1. Pre-Treatment: Baseline (Visit 1). 2. Post-treatment: Two weeks later (Visit 3). ]
  • Scores on the Adult ADHD Self-Report Scale (ASRS) questionnaire [ Time Frame: 1. Pre-Treatment: Baseline (Visit 1). 2. Post-treatment: Two weeks later (Visit 3). 3. Follow-up: Four weeks later (Online). ]

Central Contacts and Locations

Central contacts

Francisco Gonzalez-Lima, Ph.D.

512-537-5257UTBrainProject@gmail.com

Locations

The University of Texas at Austin

Recruiting

Austin, Texas, United States, 78701

Contacts

Francisco Gonzalez-Lima, Ph.D.

512-537-5257gonzalezlima@utexas.edu

More Information

Sponsor

Francisco Gonzalez-Lima, PhD

Last update posted

Jun 22, 2026

Last verified

May, 2026

Keywords

  • ADHD
  • transcranial photobiomodulation
  • cognition
  • prefrontal cortex
  • brain metabolism

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Francisco Gonzalez-Lima, PhD on 2026-06-22.