Attention Deficit Hyperactivity DisorderNCT05802680
Neurocognitive Effects of Non-Invasive Near-Infrared Light Stimulation
A study testing Transcranial photobiomodulation in people with Attention Deficit Hyperactivity Disorder and Attention Difficulties, run by Francisco Gonzalez-Lima, PhD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, Attention Difficulties, Attention Deficit
- What is being tested?
- Transcranial photobiomodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2022to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas at Austin
Austin, Texas, 78712
Francisco Gonzalez-Lima, PhD, UTADHDExperiment@gmail.com
About this study
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
- Attention Deficit Hyperactivity Disorder, Attention Difficulties, Attention Deficit, Cognitive Deficit, Wellness
- Being tested
- Transcranial photobiomodulation, Sham transcranial photobiomodulation
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial photobiomodulationDevice
Administration of Sham or 1064 (+/- 50) nanometers tPBM
Sham transcranial photobiomodulationDevice
Sham treatment
| Study group | Role | What they receive |
|---|---|---|
| Sham-tPBM, non-ADHD | Sham comparator | 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). Receives: Device: Sham transcranial photobiomodulation |
| Sham-tPBM, ADHD | Sham comparator | 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). Receives: Device: Sham transcranial photobiomodulation |
| tPBM, non-ADHD | Experimental | 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). Receives: Device: Transcranial photobiomodulation |
| tPBM, ADHD | Experimental | 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). Receives: Device: Transcranial photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous Performance Task
Measure of inattention, impulsivity, sustained attention, vigilance
Measured: Up to two months
Secondary outcomes (1)
Functional near-infrared spectroscopy
Resting state and activational state using a memory task
Measured: Up to two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start9 Feb 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Francisco Gonzalez-Lima, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Francisco Gonzalez-Lima, PhD, University of Texas at Austin
- Investigators
- Douglas W Barrett, Ph.D., Study director, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802680
- Sponsor's protocol ID
- 2019080005
- Status last verified
- Jul 2025
- First submitted
- 20 Mar 2023
- Last updated
- 22 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: What data will be shared? Individual participant data that underlie the results reported in this study, after deidentification (text, tables, figures, and appendices). A data dictionary, including a description of the variables and types of data, collected for each individual, will be provided. This data will include anonymized individual participant demographic information and all outcome variables (continuous performance task, spectroscopy data).
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.
PubMed 42449279
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive Effects of Non-Invasive Near-Infrared Light Stimulation
- ClinicalTrials.gov ID
- NCT05802680
- Acronym / sponsor ID
- 2019080005
- Conditions
- Attention Deficit Hyperactivity Disorder, Attention Difficulties, Attention Deficit, Cognitive Deficit, Wellness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Francisco Gonzalez-Lima, PhDUniversity, hospital or other
- Study start
- 9 Feb 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sham-tPBM, non-ADHD | Sham comparator | Device: Sham transcranial photobiomodulationParticipants 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). |
| Sham-tPBM, ADHD | Sham comparator | Device: Sham transcranial photobiomodulationParticipants 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). |
| tPBM, non-ADHD | Experimental | Device: Transcranial photobiomodulationParticipants 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). |
| tPBM, ADHD | Experimental | Device: Transcranial photobiomodulationParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years of age or older
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial photobiomodulationAdministration of Sham or 1064 (+/- 50) nanometers tPBM | Device | tPBM, ADHD, tPBM, non-ADHD |
| Sham transcranial photobiomodulationSham treatment | Device | Sham-tPBM, ADHD, Sham-tPBM, non-ADHD |
Primary outcome
Continuous Performance Task
Time frame: Up to two months
Measure of inattention, impulsivity, sustained attention, vigilance
1 secondary outcome
Functional near-infrared spectroscopy
Time frame: Up to two months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Derived from this study: PubMed 42449279Salehpour 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.
- Individual participant dataSharing planned: Yes. What data will be shared? Individual participant data that underlie the results reported in this study, after deidentification (text, tables, figures, and appendices). A data dictionary, including a description of the variables and types of data, collected for each individual, will be provided. This data will include anonymized individual participant demographic information and all outcome variables (continuous performance task, spectroscopy data).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Douglas W Barrett, Ph.D. study director
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial photobiomodulation in people with Attention Deficit Hyperactivity Disorder and Attention Difficulties, run by Francisco Gonzalez-Lima, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francisco Gonzalez-Lima, PhD ((512) 475-8497, UTADHDExperiment@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous Performance Task (time frame: Up to two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05802680, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.