Effects of Transcranial Photobiomodulation in ADHD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Active transcranial photobiomodulation, Sham transcranial photobiomodulation.
- Who it may be relevant to
- Registry conditions: Attention Deficit Hyperactivity Disorder. Basic parameters: 18 years — 44 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Transcranial Photobiomodulation on Cognition and Brain Metabolism in Adults With ADHD
Overview
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.
Interventions
- Device Active transcranial photobiomodulation
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. - Device Sham transcranial photobiomodulation
Identical procedure as active group, but without 1064-nm light emitted by the device.
Primary outcome measures
- Performance on the Continuous Performance Task [Time frame: 1. Pre-Treatment: Baseline (Visit 1). 2. Post-treatment: Two weeks later (Visit 3).]
- Prefrontal oxygenation (functional near-infrared spectroscopy) [Time frame: 1. Pre-Treatment: Baseline (Visit 1). 2. Post-treatment: Two weeks later (Visit 3).]
- 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).]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Currently pregnancy
- Any sham or active photobiomodulation treatment within the past five weeks.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- The University of Texas at Austin — Austin
Identifiers
NCT: NCT07203092 · STUDY00007909