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NCT05802680 · ClinicalTrials.gov registry record · NA
Neurocognitive Effects of Non-Invasive Near-Infrared Light Stimulation
A NA study of Attention Deficit Hyperactivity Disorder and Wellness, sponsored by University of Texas at Austin.
- Recruiting
- Registry status
- NA
- Development phase
- 500
- Enrollment target
- 1
- Study location
NCT05802680 is a NA study of Attention Deficit Hyperactivity Disorder and Wellness that is actively recruiting participants, run by University of Texas at Austin. The registered enrollment target is 500 participants, above the 201-participant average among 88 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (149% higher). The trial reports 1 study location across 1 state.
The verdict
NCT05802680, a NA study of Attention Deficit Hyperactivity Disorder and Wellness, is actively recruiting participants, sponsored by University of Texas at Austin.
- RECRUITING
- Registry status
- NA
- Development phase
- 500 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- DEVICE Transcranial photobiomodulation
- DEVICE Sham transcranial photobiomodulation
Study Locations (1)
Texas
- The University of Texas at Austin - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2022-02-09 |
| Est. Completion | 2027-02-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05802680
The ClinicalTrials.gov registry entry for NCT05802680 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 201-participant average among 88 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (149% higher). The listed sponsor is University of Texas at Austin, which has 257 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Attention Deficit Hyperactivity Disorder appearing as the primary indexed condition, and to 2 interventions - of which Transcranial photobiomodulation is the first listed.
NCT05802680 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT05802680 about?
NCT05802680 is a clinical study titled "Neurocognitive Effects of Non-Invasive Near-Infrared Light Stimulation". 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...
What is the current status of trial NCT05802680?
This trial is currently recruiting. It is a NA study. The enrollment target is 500 participants. The study started on 2022-02-09. Estimated completion is 2027-02-01.
What conditions does trial NCT05802680 study?
This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder, Wellness, Attention Difficulties, Cognitive Deficit, Attention-deficit.
What interventions are being tested in trial NCT05802680?
The interventions under investigation include: Transcranial photobiomodulation (DEVICE), Sham transcranial photobiomodulation (DEVICE).
Who is sponsoring clinical trial NCT05802680?
This trial is sponsored by University of Texas at Austin, which has 257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05802680 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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