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Neurocognitive Effects of Non-Invasive Near-Infrared Light Stimulation

Primary Purpose

Attention Deficit Hyperactivity Disorder, Attention Difficulties, Attention Deficit

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial photobiomodulation
Sham transcranial photobiomodulation
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The University of Texas at AustinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Sham Comparator

Sham Comparator

Experimental

Experimental

Arm Label

Sham-tPBM, non-ADHD

Sham-tPBM, ADHD

tPBM, non-ADHD

tPBM, ADHD

Arm Description

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).

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).

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).

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).

Outcomes

Primary Outcome Measures

Continuous Performance Task
Measure of inattention, impulsivity, sustained attention, vigilance

Secondary Outcome Measures

Functional near-infrared spectroscopy
Resting state and activational state using a memory task

Full Information

First Posted
March 20, 2023
Last Updated
July 6, 2023
Sponsor
University of Texas at Austin
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1. Study Identification

Unique Protocol Identification Number
NCT05802680
Brief Title
Neurocognitive Effects of Non-Invasive Near-Infrared Light Stimulation
Official Title
Neurocognitive Effects of Non-Invasive Near-Infrared Light Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 9, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder, Attention Difficulties, Attention Deficit, Cognitive Deficit, Wellness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sham-tPBM, non-ADHD
Arm Type
Sham Comparator
Arm Description
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).
Arm Title
Sham-tPBM, ADHD
Arm Type
Sham Comparator
Arm Description
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).
Arm Title
tPBM, non-ADHD
Arm Type
Experimental
Arm Description
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).
Arm Title
tPBM, ADHD
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Transcranial photobiomodulation
Intervention Description
Administration of Sham or 1064 (+/- 50) nanometers tPBM
Intervention Type
Device
Intervention Name(s)
Sham transcranial photobiomodulation
Intervention Description
Sham treatment
Primary Outcome Measure Information:
Title
Continuous Performance Task
Description
Measure of inattention, impulsivity, sustained attention, vigilance
Time Frame
Up to two months
Secondary Outcome Measure Information:
Title
Functional near-infrared spectroscopy
Description
Resting state and activational state using a memory task
Time Frame
Up to two months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 years of age or older Exclusion Criteria: None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francisco Gonzalez-Lima, PhD
Phone
(512) 475-8497
Email
UTADHDExperiment@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas W Barrett, Ph.D.
Organizational Affiliation
University of Texas at Austin
Official's Role
Study Director
Facility Information:
Facility Name
The University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco Gonzalez-Lima, PhD
Email
UTADHDExperiment@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Neurocognitive Effects of Non-Invasive Near-Infrared Light Stimulation

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