[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647277":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":38,"centralContacts":43,"locations":53,"responsibleParty":70,"collaborators":72,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":37,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":37,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":104,"whyStopped":37,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Hospital de Clinicas de Porto Alegre","OTHER",[8,14,18,22,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Continuous Wave (CW) tPBM","EXPERIMENTAL","Active near-infrared (NIR) transcranial photobiomodulation delivered in Continuous Wave (CW) mode using the NIR device, providing a constant baseline irradiance to achieve the target total energy dose (J).",[13],"Combination Product: Transcranial Photobiomodulation",{"label":15,"type":10,"description":16,"interventionNames":17},"10 Hz Pulsed tPBM","Active NIR light delivered in pulsed mode at a frequency of 10 Hz. It matched across frequencies to ensure that the average irradiance (mW\u002Fcm2) and total energy dose (J) remain identical to the CW baseline within the same exposure time.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"40 Hz Pulsed tPBM","Active NIR light delivered in pulsed mode at a frequency of 40 Hz. It matched across frequencies to ensure that the average irradiance (mW\u002Fcm2) and total energy dose (J) remain identical to the CW baseline within the same exposure time.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"100 Hz Pulsed tPBM","Active NIR light delivered in pulsed mode at a frequency of 100 Hz. It matched across frequencies to ensure that the average irradiance (mW\u002Fcm2) and total energy dose (J) remain identical to the CW baseline within the same exposure time.",[13],{"label":27,"type":28,"description":29,"interventionNames":30},"Sham Comparator (Sham tPBM)","SHAM_COMPARATOR","Inactive transcranial photobiomodulation (tPBM) delivered near-infrared device. To ensure successful participant blinding, the device will be programmed to deliver a minimal, non-therapeutic power output of visible red light (660 nm), which serves as a visual guide mimic but delivers negligible energy to the cortical tissue (0 J of active near-infrared light). Total exposure time, acoustic signals, and equipment interface will be identical to the active arms.",[13],[32],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"COMBINATION_PRODUCT","Transcranial Photobiomodulation","Transcranial photobiomodulation (tPBM) is a non-invasive, non-thermal neuromodulatory modality that utilizes low-power coherent (laser) or non-coherent (light-emitting diodes, LEDs) light sources within the red (lambda = 600-700 nm) and near-infrared (NIR; lambda = 700-1100 nm) spectral windows to modulate cortical function. Structurally tailored to penetrate superficial anatomical barriers-including the scalp, skull, and meninges-tPBM delivers photons directly to the cerebral cortex.",[15,23,19,9,27],null,[39],{"name":40,"affiliation":41,"role":42},"Marco A Caldieraro, Doctor","Federal University of Health Science of Porto Alegre","PRINCIPAL_INVESTIGATOR",[44,49],{"name":45,"role":46,"phone":47,"phoneExt":37,"email":48},"Marco A Caldieraro, MD PhD","CONTACT","+555199109-5177","mcaldieraro@hcpa.edu.br",{"name":50,"role":46,"phone":51,"phoneExt":37,"email":52},"Victor CS Araújo, MD Msc","+5551997360799","vcaraujo@hcpa.edu.br",[54],{"facility":55,"status":37,"city":56,"state":57,"zip":37,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Hospital de Clínicas de Porto Alegre","Porto Alegre","Rio Grande do Sul","Brazil","BR",{"type":61,"coordinates":62},"Point",[63,64],-51.23019,-30.03283,{"lat":64,"lon":63},[67,69],{"name":45,"role":46,"phone":68,"phoneExt":37,"email":48},"+5551991095177",{"name":50,"role":46,"phone":51,"phoneExt":37,"email":52},{"type":71,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR",[73,75],{"name":74,"class":6},"Federal University of Rio Grande do Sul",{"name":76,"class":77},"Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.","OTHER_GOV","100647277","phase-1-frequency-dependent-effects-of-transcranial-photobiomodulation-on-cortical-excitability-100647277",false,"NCT07707284","Frequency-Dependent Effects of Transcranial Photobiomodulation on Cortical Excitability","Frequency-Dependent Effects of Transcranial Photobiomodulation on Cortical Excitability and Fine Motor Performance: A Randomized, Double-Blind, Sham-Controlled, Crossover Trial","Inclusion Criteria:\n\n* Voluntary Participation: Participants who are clear of their cognitive faculties, capable of understanding all experimental procedures, and who provide written informed consent prior to enrollment.\n* Neurologically and Psychiatrically Healthy Status: Individuals with no current or prior history of neurological, neurodevelopmental, or psychiatric conditions;\n* Age Range: Young adult volunteers aged between 18 and 35 years.\n\nExclusion Criteria:\n\n* Use of any continuous psychotropic medication within the past 12 months.\n* Any current psychiatric diagnosis based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).\n* Diagnosis of any neurological disorder capable of altering cortical excitability (e.g., seizures\u002Fepilepsy, cerebrovascular accidents\u002Fstroke, brain tumors).\n* Any clinical, psychological, or social condition that, in the investigator's opinion, places the participant at an increased risk, compromises participant safety, or precludes full compliance and successful completion of the study protocol.\n* Presence of any intracranial devices or implants, including cochlear implants and aneurysm clips.\n* Severe or uncompensated systemic medical illness that could interfere with study participation or confound physiological outcomes.\n* Participation in any other interventional neuromodulation study within the preceding 6 months.",true,"ALL","18 Years","35 Years",{"count":90,"type":91},20,"ESTIMATED","INTERVENTIONAL",[94],"PHASE1","This study aims to investigate the frequency-dependent effects of near-infrared (NIR) transcranial photobiomodulation (tPBM) on human cortical excitability and fine motor performance. A cohort of 20 healthy adult volunteers (aged 18-35 years) will participate in a randomized, double-blind, sham-controlled, single-center study utilizing a within-subject, five-arm crossover design. Each participant will undergo five distinct experimental conditions separated by a strict washout period: active Continuous Wave (CW) tPBM, active pulsed tPBM at three neural oscillation frequencies (10 Hz, 40 Hz, and 100 Hz), and an inactive Sham comparator. All interventions will be delivered using a clinical-grade near-infrared device.\n\nTo isolate the specific effects of pulse frequency from overall energy delivery, the total energy dose (cumulative Joules) and total exposure time will be held perfectly constant across all active arms. The pulsed conditions will keeps the average irradiance and cumulative fluence identical to the continuous wave mode. Cortical excitability will be assessed via single- and paired-pulse Transcranial Magnetic Stimulation (TMS) protocols over the primary motor cortex (M1). Fine motor performance will be quantified using a smartphone-based Finger Tapping Test (FTT). Safety and systemic parameters will be tracked using the Systematic Assessment for Treatment Emergent Events - Systematic Inquiry (SAFTEE-SI) and vital signs. The central hypothesis is that distinct modulation frequencies will differentially influence corticospinal excitability and motor execution, independent of the total energy delivered.",[97,34,98],"Healthy Volunteers (HV)","Cortical Excitability",[100,101,102,103],"Transcranial photobiomodulation","Cortical excitability","Healthy volunteers","Finger Tapping Test","NOT_YET_RECRUITING","2026-07-27",{"date":107,"type":108},"2026-07-28","ACTUAL",{"date":110,"type":91},"2027-05",{"date":112,"type":91},"2028-07",{"name":5,"class":6},1]