[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659212":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":52,"studyPopulation":41,"armGroups":53,"interventions":66,"overallOfficials":41,"centralContacts":76,"locations":82,"responsibleParty":108,"collaborators":111,"id":114,"slug":115,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":41,"eligibilityCriteria":120,"healthyVolunteers":121,"sex":122,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":41,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":135,"overallStatus":143,"whyStopped":41,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},{"fullName":5,"class":6},"Centro Universitário Augusto Motta","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":41},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Incidence and Severity of Treatment-Emergent Adverse Events Associated With Transcranial Direct Current Stimulation","Treatment-emergent adverse events will be assessed using a structured checklist documenting the presence and intensity of tingling\u002Fitching, warmth or burning sensation, skin redness, headache, dizziness, nausea, fatigue or drowsiness, visual symptoms, and other spontaneously reported symptoms. Symptoms present at baseline will be recorded, and an event will be considered treatment-emergent if it occurs after the start of stimulation or increases in intensity relative to baseline.\n\nFor each event, severity will be categorized as none, mild, moderate, or severe. Stimulation interruptions, inability to complete the stimulation session, and adverse events requiring additional assessment or care will also be recorded. The number and proportion of participants experiencing each treatment-emergent adverse event, together with its severity, will be reported.","Baseline (pre-stimulation); during the 20-minute stimulation session; immediately post-stimulation; 2 hours post-stimulation; and approximately 24 hours post-stimulation.",{"measure":14,"description":15,"timeFrame":16},"Change in Vocal Performance Scores","Vocal performances will be audiovisually recorded and evaluated by blinded independent expert raters using an adapted analytical vocal-performance rubric based on Gynnild (2015). The rubric evaluates Technique, Language\u002FText, Musicality, Ability to Communicate, and Choice of Repertoire. Performance grades range from A to F and are converted to numerical values from 5 to 0, with higher scores indicating better vocal performance. Because all participants perform the same standardized repertoire, the Choice of Repertoire domain will not contribute to the primary performance score. The primary vocal-performance score will be calculated as the mean of the four applicable domain scores (Technique, Language\u002FText, Musicality, and Ability to Communicate), each scored from 0 to 5, resulting in an overall mean score ranging from 0 to 5. Higher scores indicate better vocal performance. Changes over time will be compared between the active and sham groups.","Baseline, immediately after intervention, and 2 hours after intervention",{"measure":14,"description":18,"timeFrame":16},"Vocal performances will be audiovisually recorded and evaluated by blinded independent expert raters using an adapted analytical vocal-performance rubric based on Gynnild (2015). The rubric evaluates technique, language\u002Ftext, musicality, ability to communicate, and choice of repertoire. Performance grades range from A to F and are converted to numerical values from 5 to 0, with higher scores indicating better vocal performance. Because all participants perform the same standardized repertoire, the choice-of-repertoire domain will not contribute to the primary performance score. The primary vocal-performance score will be calculated from the applicable rubric domains, and changes over time will be compared between the active and sham groups.",[20,23,26,29,33,37],{"measure":21,"description":22,"timeFrame":16},"Change in Self-Reported Vocal Performance","Participants will rate their own vocal performance on a numerical rating scale from 0 to 10, where 0 represents the worst possible performance that day and 10 represents the best possible performance that day. Higher scores indicate better self-perceived vocal performance.",{"measure":24,"description":25,"timeFrame":16},"Change in Self-Reported Nervousness","Participants will rate their nervousness related to the vocal performance on a numerical rating scale from 0 to 10, where 0 represents no nervousness and 10 represents the highest level of nervousness experienced. Higher scores indicate greater self-reported nervousness.",{"measure":27,"description":28,"timeFrame":16},"Change in Self-Reported Confidence","Participants will rate their confidence regarding the vocal performance on a numerical rating scale from 0 to 10, where 0 represents no confidence and 10 represents the highest possible confidence. Higher scores indicate greater self-reported confidence.",{"measure":30,"description":31,"timeFrame":32},"Participant Perception of Intervention Allocation","Participants will report whether they believe they received active stimulation, sham stimulation, or whether they do not know which condition they received. Responses will be used to evaluate the effectiveness of participant blinding.","At the end of the study session, approximately 2 hours after intervention",{"measure":34,"description":35,"timeFrame":36},"Completion Rate","Completion rate will be calculated as the proportion of enrolled participants who complete all planned study procedures, including baseline assessment, the assigned tDCS or sham session, immediate post-intervention assessment, and the 2-hour post-intervention assessment. The number and percentage of participants completing the full study protocol will be reported.","From enrollment through completion of the 2-hour post-intervention assessment",{"measure":38,"description":39,"timeFrame":40},"Protocol Adherence","Protocol adherence will be assessed as the proportion of enrolled participants who complete the assigned stimulation session and all planned study assessments according to the predefined protocol without major protocol deviations. The number and percentage of participants with complete adherence will be reported, and protocol deviations will be documented.","From enrollment through completion of the 2-hour post-intervention assessment.",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":41,"primaryPurpose":6,"observationalModel":41,"timePerspective":41,"maskingInfo":45},"RANDOMIZED","PARALLEL",{"masking":46,"maskingDescription":47,"whoMasked":48},"TRIPLE","Participants, investigators conducting the study sessions, and outcome assessors will remain blinded to treatment allocation. Randomization and stimulation codes will be prepared and managed by an independent researcher who will not participate in participant assessment, intervention delivery, or outcome evaluation. Allocation will remain concealed until completion of data collection and blinded outcome assessment, except when unblinding is required for participant safety.",[49,50,51],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","This randomized parallel-group pilot study will evaluate the safety, tolerability, and acute effects of transcranial direct current stimulation (tDCS) in adolescent singers aged 12 to 16 years.\n\nTwenty-four participants will be allocated in a 1:1 ratio to active or sham stimulation. Active tDCS will be delivered in a single session at 2.0 mA for 20 minutes using 5 × 7 cm electrodes, with the anode positioned over C5 to target the left laryngeal primary motor cortex and the cathode positioned over the right supraorbital region. The sham condition will use the same electrode montage and overall session duration and will reproduce the initial sensations associated with stimulation without sustained current delivery.\n\nParticipants will perform the same standardized vocal piece, \"Repousa Participants will perform the same standardized vocal piece, \"Repousa tranquillo, O meigo Jesus (Lullaby for Baby Jesus),\" a traditional Brazilian song listed in ABRSM Singing Grade 2, List A, in G minor, arranged by Hargest Jones and published in Songs of Christmas (Boosey \\& Hawkes), at baseline, immediately after stimulation, and approximately two hours after stimulation. Performances will be audiovisually recorded, pseudonymized, randomized, and evaluated by blinded expert raters using an adapted analytical vocal-performance rubric based on Gynnild (2015). The rubric evaluates Technique, Language\u002FText, Musicality, Ability to Communicate, and Choice of Repertoire using grades A through F converted to numerical values from 5 to 0. Because repertoire is standardized by the protocol, the Choice of Repertoire domain will not contribute to the primary vocal-performance score.\n\nSafety and tolerability will be assessed throughout the session and during follow-up using a structured symptom checklist and predefined stopping criteria. Participants will also provide brief 0-10 ratings of nervousness, confidence, and self-perceived vocal performance. These measures are exploratory and are not intended for psychological diagnosis. The study will additionally assess the effectiveness of blinding and the feasibility of conducting a controlled tDCS protocol in adolescent singers.\n\nWritten informed consent from a legal guardian and written assent from the adolescent will be obtained before any study procedure. Participation is voluntary and will not influence grades, artistic selection, scholarships, or continued participation in any musical program.",[54,60],{"label":55,"type":56,"description":57,"interventionNames":58},"Active tDCS","EXPERIMENTAL","Participants will receive a single 20-minute session of active transcranial direct current stimulation (tDCS) at 2.0 mA using 5 × 7 cm electrodes, with the anode positioned over C5 to target the left laryngeal primary motor cortex and the cathode positioned over the right supraorbital region.",[59],"Device: Active Transcranial Direct Current Stimulation (tDCS)",{"label":61,"type":62,"description":63,"interventionNames":64},"Sham tDCS","SHAM_COMPARATOR","Participants will receive a single 20-minute sham tDCS session using the same electrode montage as the active condition. Sham stimulation will reproduce the initial sensations associated with tDCS through an initial ramp-up and brief stimulation period, without sustained current delivery.",[65],"Device: Sham Transcranial Direct Current Stimulation (tDCS)",[67,72],{"type":68,"name":69,"description":70,"armGroupLabels":71,"otherNames":41},"DEVICE","Active Transcranial Direct Current Stimulation (tDCS)","Participants will receive a single session of active transcranial direct current stimulation (tDCS). The anode will be positioned over C5, targeting the left laryngeal primary motor cortex, and the cathode over the right supraorbital region using 5 × 7 cm electrodes. Current will be gradually increased to 2.0 mA, maintained for 20 minutes, and gradually reduced at the end of stimulation.",[55],{"type":68,"name":73,"description":74,"armGroupLabels":75,"otherNames":41},"Sham Transcranial Direct Current Stimulation (tDCS)","Participants will receive a single sham transcranial direct current stimulation (tDCS) session using the same electrode montage as the active condition, with the anode positioned over C5 and the cathode over the right supraorbital region using 5 × 7 cm electrodes. An initial ramp-up and brief stimulation period will reproduce the initial sensations associated with tDCS, followed by discontinuation of sustained current. The sham session will have the same overall duration as the active session.",[61],[77],{"name":78,"role":79,"phone":80,"phoneExt":41,"email":81},"Frederico Barreto Kochem, PT, PhD","CONTACT","+55 24 98156-9166","frederico_kochem@hotmail.com",[83],{"facility":84,"status":41,"city":85,"state":85,"zip":86,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":94,"contacts":95},"Orquestra Maré do Amanhã","Rio de Janeiro","21042-432","Brazil","BR",{"type":90,"coordinates":91},"Point",[92,93],-43.18223,-22.90642,{"lat":93,"lon":92},[96,97,99,101,104,106],{"name":78,"role":79,"phone":80,"phoneExt":41,"email":81},{"name":78,"role":98,"phone":41,"phoneExt":41,"email":41},"PRINCIPAL_INVESTIGATOR",{"name":100,"role":98,"phone":41,"phoneExt":41,"email":41},"Débora Cristina Lima da Silva, PT, PhD",{"name":102,"role":103,"phone":41,"phoneExt":41,"email":41},"Ricardo Galhardoni, PhD","SUB_INVESTIGATOR",{"name":105,"role":103,"phone":41,"phoneExt":41,"email":41},"Renato Santos de Almeida, PT, PhD",{"name":107,"role":103,"phone":41,"phoneExt":41,"email":41},"Rômulo de Freitas Santos Nicolai, BMus (Classical Voice), MMus",{"type":98,"investigatorFullName":109,"investigatorTitle":110,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Frederico Barreto Kochem","Principal Investigator and Professor at Centro Universitário Augusto Motta (UNISUAM)",[112],{"name":113,"class":6},"Neuromodulacao em Foco","100659212","safety-and-acute-effects-of-tdcs-on-vocal-performance-in-adolescent-singers-100659212",false,"NCT07861490","Safety and Acute Effects of tDCS on Vocal Performance in Adolescent Singers","Safety, Tolerability, and Acute Effects of Transcranial Direct Current Stimulation on Vocal Performance in Adolescent Singers Aged 12 to 16 Years: A Randomized Sham-Controlled Proof-of-Concept Study","Inclusion Criteria:\n\n* Age 12 to 16 years, inclusive, at the time of enrollment.\n* Regular participation in vocal music training for at least 12 months.\n* Ability to safely perform the standardized vocal piece selected for the study.\n* General health status compatible with participation, confirmed through a pre-session safety screening.\n* No known neurological or clinical condition considered to increase the risk associated with stimulation.\n* No current use of medication or substances considered by the study team to substantially alter cortical excitability or increase procedural risk.\n* Written informed consent from a legal guardian.\n* Written assent from the adolescent and voluntary willingness to participate.\n\nExclusion Criteria:\n\n* History of epilepsy or non-febrile seizures.\n* Relevant brain injury, previous cranial surgery, or other neurological condition considered incompatible with the protocol.\n* Pacemaker, implanted electronic device, neurostimulator, or cranial metallic implant that could pose a risk or interfere with stimulation.\n* Current use of anticonvulsant medication or other medication considered by the study team to represent a contraindication or unacceptable precaution.\n* Previous experience with tDCS when such experience could compromise blinding.\n* Dermatitis, wounds, infection, burns, significant pain, or other scalp abnormalities at the planned electrode sites.\n* Known or suspected pregnancy, as a precaution; pregnancy testing will not be performed as part of the study.\n* Acute illness or relevant symptoms on the day of the session, including fever, significant headache, persistent dizziness, relevant sleep deprivation, or acute upper respiratory symptoms when these findings justify postponement or exclusion for safety or performance-related reasons.",true,"ALL","12 Years","16 Years",{"count":126,"type":127},24,"ESTIMATED","INTERVENTIONAL",[130],"NA","This randomized, sham-controlled proof-of-concept study aims to investigate the safety, tolerability, and acute effects of transcranial direct current stimulation (tDCS) on vocal performance in adolescent singers aged 12 to 16 years. Twenty-four participants will be randomly assigned in a 1:1 ratio to active or sham tDCS. Active stimulation will consist of 2.0 mA anodal tDCS applied for 20 minutes using 5 × 7 cm electrodes, with the anode positioned over C5 to target the left laryngeal primary motor cortex and the cathode over the right supraorbital region. Participants will perform the same standardized vocal piece before stimulation, immediately after stimulation, and approximately two hours after stimulation. Vocal performances will be audiovisually recorded and evaluated by blinded expert raters using an adapted analytical vocal-performance rubric based on Gynnild (2015). Safety and tolerability will be monitored using a structured symptom checklist and predefined stopping criteria. Self-rated vocal performance, nervousness, confidence, blinding, and protocol feasibility will also be explored.",[133,134],"Vocal Performance","Neuromodulation",[136,137,133,138,139,140,141,142],"Transcranial Direct Current Stimulation","Adolescent","Singers","Laryngeal Motor Cortex","Safety","Tolerability","Motor Performance","NOT_YET_RECRUITING","2026-10-07",{"date":146,"type":147},"2026-10-13","ACTUAL",{"date":144,"type":127},{"date":150,"type":127},"2026-12-31",{"name":5,"class":6},1]