[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650832":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":39,"centralContacts":44,"locations":54,"responsibleParty":71,"collaborators":73,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":48,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":48,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":105,"whyStopped":48,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"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],[38],"Low Level Laser Therapy",[40],{"name":41,"affiliation":42,"role":43},"Marco A Caldieraro, MD PhD","Federal University of Health Science of Porto Alegre","PRINCIPAL_INVESTIGATOR",[45,50],{"name":41,"role":46,"phone":47,"phoneExt":48,"email":49},"CONTACT","+555199109-5177",null,"mcaldieraro@hcpa.edu.br",{"name":51,"role":46,"phone":52,"phoneExt":48,"email":53},"Victor CS Araújo, MD Msc","+5551997360799","vcaraujo@hcpa.edu.br",[55],{"facility":56,"status":48,"city":57,"state":58,"zip":48,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Hospital de Clínicas de Porto Alegre","Porto Alegre","Rio Grande do Sul","Brazil","BR",{"type":62,"coordinates":63},"Point",[64,65],-51.23019,-30.03283,{"lat":65,"lon":64},[68,70],{"name":41,"role":46,"phone":69,"phoneExt":48,"email":49},"+5551991095177",{"name":51,"role":46,"phone":52,"phoneExt":48,"email":53},{"type":72,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR",[74,76],{"name":75,"class":6},"Federal University of Rio Grande do Sul",{"name":77,"class":78},"Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.","OTHER_GOV","100650832","phase-1-frequency-dependent-effects-of-transcranial-photobiomodulation-with-same-peak-irradiance-on-cortical-excitability-and-fine-motor-performance-100650832",false,"NCT07752602","Frequency-Dependent Effects of Transcranial Photobiomodulation With Same Peak Irradiance on Cortical Excitability and Fine Motor Performance","Frequency-Dependent Effects of Transcranial Photobiomodulation With Same Peak Irradiance on Cortical Excitability and Fine Motor Performance: A Randomized, Double-Blind, Sham-Controlled, Within-Subject 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":91,"type":92},20,"ESTIMATED","INTERVENTIONAL",[95],"PHASE1","This study investigates the frequency-dependent neuromodulatory effects of transcranial photobiomodulation (tPBM) over the primary motor cortex (M1) on cortical excitability and fine motor performance in healthy young adults. Using a randomized, double-blind, sham-controlled, 5-arm crossover design, 20 healthy participants will undergo five experimental conditions separated by a mandatory 7-day washout period: Continuous Wave (CW), 10 Hz pulsed tPBM, 40 Hz pulsed tPBM, 100 Hz pulsed tPBM, and a Sham control. To isolate pulse frequency while holding peak intensity constant, all active interventions will utilize an identical peak irradiance, with pulsed modes operating at a 50% duty cycle (delivering 50% of the cumulative energy dose relative to CW). Primary outcomes include corticospinal excitability measured via single- and paired-pulse Transcranial Magnetic Stimulation (TMS), alongside fine motor speed and dexterity assessed via a computerized finger-tapping task.",[98,34,99],"Healthy Volunteers (HV)","Cortical Excitability",[101,102,103,104],"Finger Tapping Test","Healthy volunteers","Cortical excitability","Transcranial photobiomodulation","NOT_YET_RECRUITING","2026-08-03",{"date":108,"type":109},"2026-08-07","ACTUAL",{"date":111,"type":92},"2027-01-01",{"date":113,"type":92},"2027-12-01",{"name":5,"class":6},1]