[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07203092":3,"trial-entities:NCT07203092":95,"trial-summary:NCT07203092":98},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":43,"secondary_outcomes":55,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":15,"eligibility_criteria":59,"std_ages":71,"locations":73,"central_contacts":89,"overall_officials":92,"references":93,"see_also_links":94},"NCT07203092","STUDY00007909","Effects of Transcranial Photobiomodulation in ADHD","Effects of Transcranial Photobiomodulation on Cognition and Brain Metabolism in Adults With ADHD","RECRUITING","2027-12","2026-05","2026-06-22","2025-09-01","Francisco Gonzalez-Lima, PhD","OTHER",false,"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).\n\nThe 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.","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.",[19],"Attention Deficit Hyperactivity Disorder",[21,22,23,24,25],"ADHD","transcranial photobiomodulation","cognition","prefrontal cortex","brain metabolism","INTERVENTIONAL","TREATMENT",[29],"NA",{"count":31,"type":32},140,"ESTIMATED",[34,39],{"type":35,"name":36,"description":37,"armGroupLabels":38},"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\u002Fcm2 power density for 8 minutes per treatment.",[36],{"type":35,"name":40,"description":41,"armGroupLabels":42},"Sham transcranial photobiomodulation","Identical procedure as active group, but without 1064-nm light emitted by the device.",[40],[44,48,51],{"measure":45,"description":46,"timeFrame":47},"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.","1. Pre-Treatment: Baseline (Visit 1). 2. Post-treatment: Two weeks later (Visit 3).",{"measure":49,"description":50,"timeFrame":47},"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.",{"measure":52,"description":53,"timeFrame":54},"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.","1. Pre-Treatment: Baseline (Visit 1). 2. Post-treatment: Two weeks later (Visit 3). 3. Follow-up: Four weeks later (Online).",[],"ALL","18 Years","44 Years",{"inclusion":60,"exclusion":67,"raw_text":70},[61,62,63,64,65,66],"English-speaking","Adults of any sex","Age range: 18-44 years","Any ethnic\u002Fracial 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.",[68,69],"Currently pregnancy","Any sham or active photobiomodulation treatment within the past five weeks.","Inclusion Criteria:\n\n* English-speaking\n* Adults of any sex\n* Age range: 18-44 years\n* Any ethnic\u002Fracial background\n* Medical history of ADHD\n* Participants may either be on a stable ADHD medication regimen (with no changes within two weeks prior to the study) or not taking medication.\n\nExclusion Criteria:\n\n* Currently pregnancy\n* Any sham or active photobiomodulation treatment within the past five weeks.",[72],"ADULT",[74],{"facility":75,"status":8,"city":76,"state":77,"zip":78,"country":79,"contacts":80,"geoPoint":86},"The University of Texas at Austin","Austin","Texas","78701","United States",[81],{"name":82,"role":83,"phone":84,"email":85},"Francisco Gonzalez-Lima, Ph.D.","CONTACT","512-537-5257","gonzalezlima@utexas.edu",{"lat":87,"lon":88},30.26715,-97.74306,[90],{"name":82,"role":83,"phone":84,"email":91},"UTBrainProject@gmail.com",[],[],[],{"nct_id":4,"conditions":96,"biomarkers":97},[19],[],{"nct_id":4,"found":99,"summary":100,"prompt_version":110},true,{"design":101,"status":102,"heading":103,"summary":104,"follow_up":105,"word_count":106,"commitments":107,"compensation":108,"drugs_mentioned":109},"This is a double-blind, sham-controlled study, meaning neither you nor the researchers will know if you are receiving the active treatment or a placebo (sham device). It plans to enroll 140 participants.","completed","Transcranial Photobiomodulation for ADHD","This study is looking at how transcranial photobiomodulation (tPBM) might help adults with Attention Deficit Hyperactivity Disorder (ADHD). tPBM uses a special light (1064-nm light) directed at the forehead to improve brain function. Researchers want to see if this treatment can improve thinking skills and brain oxygenation in people with ADHD. You might be able to join if you are an adult between 18 and 44 years old, have a medical history of ADHD, and speak English. The study will be considered successful if participants receiving the active tPBM show better attention, impulse control, and working memory, along with improved brain oxygenation. The current status of this study is unclear.","You will have one online follow-up visit four weeks after your last treatment session to assess ADHD symptoms.",110,"You would attend three in-person sessions where you receive weekly tPBM treatments. You will also complete cognitive tests and a questionnaire at the beginning, after the treatments, and one online follow-up visit four weeks later.","Not stated in the trial record.",[],"v2"]