Effects of Transcranial Photobiomodulation in ADHD
Part of paid clinical trials in Austin, Texas.
- Sponsor
- University of Texas at Austin
- Study ID
- NCT07203092
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 44 Years
- Healthy Volunteers
- Not accepted
Interventions
- Active transcranial photobiomodulation — DEVICEActive 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 — DEVICEIdentical procedure as active group, but without 1064-nm light emitted by the device.
Study Details
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.
Key Dates
- Start date
- Sep 1, 2025
- Status verified
- May 2026
- Primary completion
- Nov 30, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 140 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Active transcranial photobiomodulationParticipants in this arm will receive active transcranial photobiomodulation to the forehead, targeting prefrontal cortex.
- Sham Comparator: Sham transcranial photobiomodulationParticipants in this arm will undergo this same procedure as the active group, but with no 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). ]
Central Contacts
- Francisco Gonzalez-Lima, Ph.D.512-537-5257
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The University of Texas at Austin | Austin | Texas | 78701 |
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