Neurocognitive Effects of Non-Invasive Near-Infrared Light Stimulation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcranial photobiomodulation, Sham transcranial photobiomodulation.
- Who it may be relevant to
- Registry conditions: Attention Deficit Hyperactivity Disorder, Attention Difficulties, Attention Deficit, Cognitive Deficit. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Inattentiveness and impulsivity in healthy adults and individuals with attention deficit hyperactivity disorder (ADHD) diminish these individuals' quality of life. Cortical hypometabolism has been hypothesized to contribute to inattentiveness in ADHD. Transcranial photobiomodulation (tPBM) is a safe and non-invasive modality for activation of the prefrontal cortex. tPBM in healthy adults has been shown to augment brain oxygenation, cognition, and mood. The cognition-enhancing effect of tPBM on sustained attention in adults with ADHD remains unstudied. The investigators will evaluate whether tPBM administration to adults with and without ADHD can improve their attention. Each participant will be screened for eighteen criteria based on the Diagnostic and Statistical Manual (DSM-IV, text revised), using the validated instrument Adult ADHD Self-Report Scale (ASRS-v1.1). Blinded participants will be randomized into (I) Active-tPBM or (II) Sham-tPBM groups. After undergoing an 8-minute administration of Sham or 1064 nm tPBM to the lateral and medial right prefrontal cortex, each participant will complete a 14-minute, computer-based Conner's continuous performance task-3 (CPT-3). The investigators will examine whether adults with and without ADHD who receive Active-tPBM improve in measures of inattention, impulsivity, sustained attention, or vigilance compared to the Sham-tPBM group. Cognitive assessments of attention like the CPT-3 may evaluate the efficacy of tPBM to increase cortical metabolism in healthy adults and individuals with conditions like ADHD. The investigators anticipate their investigation will be a starting point for more sophisticated studies that focus on the implications of tPBM on cognition.
Interventions
- Device Transcranial photobiomodulation
Administration of Sham or 1064 (+/- 50) nanometers tPBM - Device Sham transcranial photobiomodulation
Sham treatment
Primary outcome measures
- Continuous Performance Task [Time frame: Up to two months]
Secondary outcome measures (1)
- Functional near-infrared spectroscopy [Time frame: Up to two months]
Eligibility criteria
Inclusion criteria
- 18 years of age or older
Exclusion criteria
- None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- The University of Texas at Austin — Austin
Publications
- Salehpour F, Barrett DW, Mirji A, Farzamnia A, Burugu V, Shah N, Gonzalez-Lima F. Transcranial photobiomodulation improves prefrontal oxygenation and impulse control in adults with ADHD: a randomized controlled trial. BMC Psychiatry. 2026 Jul 14. doi: 10.1186/s12888-026-08391-5. Online ahead of print. PMID 42449279
Identifiers
NCT: NCT05802680 · 2019080005