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 — 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 — DEVICE
    Identical 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 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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas at AustinAustinTexas78701
Francisco Gonzalez-Lima, Ph.D.
512-537-5257

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