Neurocognitive Effects of Non-Invasive Near-Infrared Light Stimulation

Study Overview
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Brief Summary
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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.

Official Title
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Neurocognitive Effects of Non-Invasive Near-Infrared Light Stimulation

Conditions
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Attention Deficit Hyperactivity Disorder, Attention Difficulties, Attention Deficit, Cognitive Deficit, Wellness

Intervention / Treatment
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* Device: Transcranial photobiomodulation
* Device: Sham transcranial photobiomodulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham-tPBM, non-ADHD<br>Participants with no medical diagnosis of ADHD will be exposed to the same conditions as treated participants, with the exception that the infrared light will be turned off (sham condition). | Device: Sham transcranial photobiomodulation<br>* Sham treatment<br>|
| Sham Comparator: Sham-tPBM, ADHD<br>Participants with a medical diagnosis of ADHD will be exposed to the same conditions as treated participants, with the exception that the infrared light will be turned off (sham condition). | Device: Sham transcranial photobiomodulation<br>* Sham treatment<br>|
| Experimental: tPBM, non-ADHD<br>Participants with no medical diagnosis of ADHD will be exposed to the same conditions as sham participants, with the exception that the infrared light will be turned on (treated condition). | Device: Transcranial photobiomodulation<br>* Administration of Sham or 1064 (+/- 50) nanometers tPBM<br>|
| Experimental: tPBM, ADHD<br>Participants with a medical diagnosis of ADHD will be exposed to the same conditions as sham participants, with the exception that the infrared light will be turned on (treated condition). | Device: Transcranial photobiomodulation<br>* Administration of Sham or 1064 (+/- 50) nanometers tPBM<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous Performance Task | Measure of inattention, impulsivity, sustained attention, vigilance | Up to two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional near-infrared spectroscopy | Resting state and activational state using a memory task | Up to two months |