Attention Deficit Hyperactivity DisorderNCT07203092
Effects of Transcranial Photobiomodulation in ADHD
A study testing Active transcranial photobiomodulation in people with Attention Deficit Hyperactivity Disorder, run by Francisco Gonzalez-Lima, PhD at 1 site in United States.
Trial summary
The investigators have previously shown that non-invasive methods of brain stimulation such as the administration of transcranial infrared light to the prefrontal cortex (PFC) can result in improvements to cognition and emotion as well as brain oxygenation. This method is called transcranial photobiomodulation (tPBM). Read more about this study
- Who is it for?
- Ages 18 to 44 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Active transcranial photobiomodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2025to Dec 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 to 44 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- English-speaking
- Adults of any sex
- Age range: 18-44 years
- Any ethnic/racial background
- Medical history of ADHD
- Participants may either be on a stable ADHD medication regimen (with no changes within two weeks prior to the study) or not taking medication.
Who cannot join
- Currently pregnancy
- Any sham or active photobiomodulation treatment within the past five weeks.
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, 78701
Francisco Gonzalez-Lima, Ph.D., 512-537-5257, gonzalezlima@utexas.edu
About this study
Official title: Effects of Transcranial Photobiomodulation on Cognition and Brain Metabolism in Adults With ADHD
The investigators have previously shown that non-invasive methods of brain stimulation such as the administration of transcranial infrared light to the prefrontal cortex (PFC) can result in improvements to cognition and emotion as well as brain oxygenation. This method is called transcranial photobiomodulation (tPBM).
The investigators hypothesize that tPBM can improve cognition and brain oxygenation in adults with attention deficit hyperactivity disorder (ADHD). The investigators will investigate the effects of repeated tPBM sessions on cognitive functioning in adults with ADHD. Specifically, the investigators hypothesize that participants that receive tPBM will show improvements in response control, sustained attention, and working memory, as well as improvements in prefrontal hemodynamics and a reduction in ADHD symptoms.
Read the detailed description
This will be a double-blind, sham-controlled study to evaluate the neurobehavioral and PFC neurometabolic effects of repeated tPBM sessions in adults with ADHD. Adults with a history of medically-diagnosed ADHD will be recruited. Participants will be randomized to two arms: (1) active tPBM or (2) sham tPBM. All participants will complete three in-person sessions and one remote follow-up visit conducted online. Participant will receive three weekly sessions of tPBM targeting the PFC using a 1064 nm laser. Cognitive performance will be assessed using the continuous performance task and 2-back task at baseline and after the final tPBM session. The investigators predict that participants receiving active tPBM will show improvements in sustained attention, impulse control, and working memory. Functional near-infrared spectroscopy recordings, collected at baseline and post-treatment, will be used to evaluate changes in PFC hemodynamic response and network interactions (functional connectivity). The investigators predict that active tPBM will enhance the PFC hemodynamic response and strengthen network interactions across prefrontal subregions. Lastly, ADHD symptomatology will be assessed using the Adult ADHD Self-Report Scale at baseline, post-treatment, and at a four-week follow-up after tPBM. The investigators predict that participants receiving active tPBM will report progressive reductions in ADHD symptoms across time points.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Active transcranial photobiomodulation, Sham transcranial photobiomodulation
- Keywords
- ADHD, transcranial photobiomodulation, cognition, prefrontal cortex, brain metabolism
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active transcranial photobiomodulationDevice
Active transcranial photobiomodulation to the forehead targeting prefrontal cortex involves administration of 1064-nm light delivered via laser with a 4 centimeter beam diameter and 250 mW/cm2 power density for 8 minutes per treatment.
Sham transcranial photobiomodulationDevice
Identical procedure as active group, but without 1064-nm light emitted by the device.
| Study group | Role | What they receive |
|---|---|---|
| Active transcranial photobiomodulation | Active comparator | Participants in this arm will receive active transcranial photobiomodulation to the forehead, targeting prefrontal cortex. Receives: Device: Active transcranial photobiomodulation |
| Sham transcranial photobiomodulation | Sham comparator | Participants in this arm will undergo this same procedure as the active group, but with no 1064-nm light emitted by the device. Receives: Device: Sham transcranial photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance on the Continuous Performance Task
The Continuous Performance Task is a widely-used cognitive measure to evaluate sustained attention, vigilance, and response control. Participants respond to letters presented on a computer screen and inhibit their responses to the letter X. There is no score on a scale. An increase in Correct Rejections on CPT = better inhibition = better outcome of treatment.
Measured: 1. Pre-Treatment: Baseline (Visit 1). 2. Post-treatment: Two weeks later (Visit 3).
Prefrontal oxygenation (functional near-infrared spectroscopy)
Participants will wear a head-mounted functional near-infrared spectroscopy device that records changes in the concentrations of oxygenated hemoglobin potentially resulting from the treatment.
Measured: 1. Pre-Treatment: Baseline (Visit 1). 2. Post-treatment: Two weeks later (Visit 3).
Scores on the Adult ADHD Self-Report Scale (ASRS) questionnaire
The ASRS is an 18-question self-assessment tool created by the World Health Organization (WHO) which evaluates symptom severity of ADHD. Minimum score=18; maximum score=90; high score = more ADHD symptoms; lower score after treatment = better outcome.
Measured: 1. Pre-Treatment: Baseline (Visit 1). 2. Post-treatment: Two weeks later (Visit 3). 3. Follow-up: Four weeks later (Online).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start1 Sep 2025
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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, Investigator
- Enrolment
- 140 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203092
- Sponsor's protocol ID
- STUDY00007909
- Status last verified
- May 2026
- First submitted
- 15 Sep 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- 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 (cognitive task data, spectroscopy data).
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
- Effects of Transcranial Photobiomodulation on Cognition and Brain Metabolism in Adults With ADHD
- ClinicalTrials.gov ID
- NCT07203092
- Acronym / sponsor ID
- STUDY00007909
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, transcranial photobiomodulation, cognition, prefrontal cortex, brain metabolism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Francisco Gonzalez-Lima, PhDUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Oct 2025 (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.
The investigators have previously shown that non-invasive methods of brain stimulation such as the administration of transcranial infrared light to the prefrontal cortex (PFC) can result in improvements to cognition and emotion as well as brain oxygenation. This method is called transcranial photobiomodulation (tPBM).
The investigators hypothesize that tPBM can improve cognition and brain oxygenation in adults with attention deficit hyperactivity disorder (ADHD). The investigators will investigate the effects of repeated tPBM sessions on cognitive functioning in adults with ADHD. Specifically, the investigators hypothesize that participants that receive tPBM will show improvements in response control, sustained attention, and working memory, as well as improvements in prefrontal hemodynamics and a reduction in ADHD symptoms.
Detailed description
This will be a double-blind, sham-controlled study to evaluate the neurobehavioral and PFC neurometabolic effects of repeated tPBM sessions in adults with ADHD. Adults with a history of medically-diagnosed ADHD will be recruited. Participants will be randomized to two arms: (1) active tPBM or (2) sham tPBM. All participants will complete three in-person sessions and one remote follow-up visit conducted online. Participant will receive three weekly sessions of tPBM targeting the PFC using a 1064 nm laser. Cognitive performance will be assessed using the continuous performance task and 2-back task at baseline and after the final tPBM session. The investigators predict that participants receiving active tPBM will show improvements in sustained attention, impulse control, and working memory. Functional near-infrared spectroscopy recordings, collected at baseline and post-treatment, will be used to evaluate changes in PFC hemodynamic response and network interactions (functional connectivity). The investigators predict that active tPBM will enhance the PFC hemodynamic response and strengthen network interactions across prefrontal subregions. Lastly, ADHD symptomatology will be assessed using the Adult ADHD Self-Report Scale at baseline, post-treatment, and at a four-week follow-up after tPBM. The investigators predict that participants receiving active tPBM will report progressive reductions in ADHD symptoms across time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active transcranial photobiomodulation | Active comparator | Device: Active transcranial photobiomodulationParticipants in this arm will receive active transcranial photobiomodulation to the forehead, targeting prefrontal cortex. |
| Sham transcranial photobiomodulation | Sham comparator | Device: Sham transcranial photobiomodulationParticipants in this arm will undergo this same procedure as the active group, but with no 1064-nm light emitted by the device. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- English-speaking
- Adults of any sex
- Age range: 18-44 years
- Any ethnic/racial background
- Medical history of ADHD
Key exclusion criteria (2 listed)
- Currently pregnancy
- Any sham or active photobiomodulation treatment within the past five weeks.
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 |
|---|---|---|
| Active transcranial photobiomodulationActive transcranial photobiomodulation to the forehead targeting prefrontal cortex involves administration of 1064-nm light delivered via laser with a 4 centimeter beam diameter and 250 mW/cm2 power density for 8 minutes per treatment. | Device | Active transcranial photobiomodulation |
| Sham transcranial photobiomodulationIdentical procedure as active group, but without 1064-nm light emitted by the device. | Device | Sham transcranial photobiomodulation |
Primary outcome
Performance on the Continuous Performance Task
Time frame: 1. Pre-Treatment: Baseline (Visit 1). 2. Post-treatment: Two weeks later (Visit 3).
The Continuous Performance Task is a widely-used cognitive measure to evaluate sustained attention, vigilance, and response control. Participants respond to letters presented on a computer screen and inhibit their responses to the letter X. There is no score on a scale. An increase in Correct Rejections on CPT = better inhibition = better outcome of treatment.
Prefrontal oxygenation (functional near-infrared spectroscopy)
Time frame: 1. Pre-Treatment: Baseline (Visit 1). 2. Post-treatment: Two weeks later (Visit 3).
Participants will wear a head-mounted functional near-infrared spectroscopy device that records changes in the concentrations of oxygenated hemoglobin potentially resulting from the treatment.
Scores on the Adult ADHD Self-Report Scale (ASRS) questionnaire
Time frame: 1. Pre-Treatment: Baseline (Visit 1). 2. Post-treatment: Two weeks later (Visit 3). 3. Follow-up: Four weeks later (Online).
The ASRS is an 18-question self-assessment tool created by the World Health Organization (WHO) which evaluates symptom severity of ADHD. Minimum score=18; maximum score=90; high score = more ADHD symptoms; lower score after treatment = better outcome.
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.
- 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 (cognitive task data, 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active transcranial photobiomodulation in people with Attention Deficit Hyperactivity Disorder, 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 6 inclusion and 2 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, Ph.D. (512-537-5257, UTBrainProject@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance on the Continuous Performance Task (time frame: 1. Pre-Treatment: Baseline (Visit 1). 2. Post-treatment: Two weeks later (Visit 3).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.