Effects of Transcranial Photobiomodulation in ADHD

NCT ID: NCT07203092

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2027-12-31

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.

Detailed 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.

Conditions

Attention Deficit Hyperactivity Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active transcranial photobiomodulation

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

Group Type: ACTIVE_COMPARATOR

Active transcranial photobiomodulation

Intervention Type: DEVICE

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.

Group Type: SHAM_COMPARATOR

Sham transcranial photobiomodulation

Intervention Type: DEVICE

Identical procedure as active group, but without 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.

Intervention Type: DEVICE

Sham transcranial photobiomodulation

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Francisco Gonzalez-Lima, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The University of Texas at Austin

Austin, Texas, United States

Countries

United States

Central Contacts

Francisco Gonzalez-Lima, Ph.D.

Role: CONTACT

UTBrainProject@gmail.com

512-537-5257

Facility Contacts

Francisco Gonzalez-Lima, Ph.D.

Role: primary

gonzalezlima@utexas.edu

512-537-5257

Other Identifiers

STUDY00007909

Identifier Type: -

Identifier Source: org_study_id