Neurocognitive Effects of Non-Invasive Near-Infrared Light Stimulation

NCT ID: NCT05802680

Last Updated: 2025-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-09

Study Completion Date

2027-02-01

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.

Detailed Description

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Conditions

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Attention Deficit Hyperactivity Disorder Attention Difficulties Attention Deficit Cognitive Deficit Wellness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Sham-tPBM, non-ADHD

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).

Group Type SHAM_COMPARATOR

Sham transcranial photobiomodulation

Intervention Type DEVICE

Sham treatment

Sham-tPBM, ADHD

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).

Group Type SHAM_COMPARATOR

Sham transcranial photobiomodulation

Intervention Type DEVICE

Sham treatment

tPBM, non-ADHD

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).

Group Type EXPERIMENTAL

Transcranial photobiomodulation

Intervention Type DEVICE

Administration of Sham or 1064 (+/- 50) nanometers tPBM

tPBM, ADHD

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).

Group Type EXPERIMENTAL

Transcranial photobiomodulation

Intervention Type DEVICE

Administration of Sham or 1064 (+/- 50) nanometers tPBM

Interventions

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Transcranial photobiomodulation

Administration of Sham or 1064 (+/- 50) nanometers tPBM

Intervention Type DEVICE

Sham transcranial photobiomodulation

Sham treatment

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Texas at Austin

OTHER

Sponsor Role lead

Responsible Party

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Francisco Gonzalez-Lima, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Douglas W Barrett, Ph.D.

Role: STUDY_DIRECTOR

University of Texas at Austin

Locations

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The University of Texas at Austin

Austin, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Francisco Gonzalez-Lima, PhD

Role: CONTACT

(512) 475-8497

Facility Contacts

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Francisco Gonzalez-Lima, PhD

Role: primary

Other Identifiers

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2019080005

Identifier Type: -

Identifier Source: org_study_id

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