[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656467":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":37,"studyPopulation":25,"armGroups":38,"interventions":51,"overallOfficials":25,"centralContacts":60,"locations":66,"responsibleParty":91,"collaborators":94,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":25,"eligibilityCriteria":103,"healthyVolunteers":104,"sex":105,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":25,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":118,"overallStatus":126,"whyStopped":25,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"Centro Universitário Augusto Motta","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":25},[9,13],{"measure":10,"description":11,"timeFrame":12},"Safety and Tolerability of Transcranial Direct Current Stimulation","Safety and tolerability 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. Stimulation interruptions, inability to complete the session, and adverse events requiring additional assessment or care will also be recorded. The number and proportion of participants experiencing each event and its severity will be described.","Baseline (pre-stimulation); periprocedural (throughout the 30-minute stimulation session); immediately post-stimulation; 2 hours post-stimulation; and approximately 24 hours post-stimulation.",{"measure":14,"description":15,"timeFrame":16},"Change in Musical Performance Scores","Instrumental musical performances will be audiovisually recorded and evaluated by blinded independent expert raters using the Rubric for the Assessment of Music Performance Achievement. The rubric evaluates technical performance, interpretative quality, stylistic coherence, repertoire-related performance characteristics, and stage presence. Each domain is rated from 1 to 6, with higher scores indicating better musical performance. Changes over time will be compared between the active and sham groups.","Baseline, immediately after intervention, and 2 hours after intervention",[18,21],{"measure":19,"description":20,"timeFrame":16},"Change in Self-Reported Musical Performance","Description:\n\nParticipants will rate their own instrumental musical 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 performance.",{"measure":22,"description":23,"timeFrame":24},"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",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":29,"primaryPurpose":6,"observationalModel":25,"timePerspective":25,"maskingInfo":30},"RANDOMIZED","PARALLEL","Parallel Assignment",{"masking":31,"maskingDescription":32,"whoMasked":33},"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.",[34,35,36],"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 instrumentalists 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 30 minutes using 5 × 7 cm electrodes, with the anode positioned over FCz and the cathode over Fp2. The sham condition will use the same electrode montage and will reproduce the initial sensations associated with stimulation without sustained current.\n\nParticipants will perform the same previously learned instrumental musical piece or excerpt 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 a standardized music performance rubric. Safety and tolerability will be assessed throughout the session and during follow-up using a structured symptom checklist and predefined stopping criteria.\n\nParticipants will also provide brief 0-10 ratings of nervousness, confidence, and self-perceived musical 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 instrumentalists.\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.",[39,45],{"label":40,"type":41,"description":42,"interventionNames":43},"Active tDCS","EXPERIMENTAL","Participants will receive a single session of active transcranial direct current stimulation (tDCS) at 2.0 mA for 30 minutes, using 5 × 7 cm electrodes positioned over FCz and Fp2.",[44],"Device: Active Transcranial Direct Current Stimulation (tDCS)",{"label":46,"type":47,"description":48,"interventionNames":49},"Sham tDCS","SHAM_COMPARATOR","Sham stimulation will reproduce the initial sensations of tDCS without sustained current delivery. Participants will receive a single session of sham transcranial direct current stimulation (tDCS) at 2.0 mA for 30 minutes, using 5 × 7 cm electrodes positioned over FCz and Fp2.",[50],"Device: Sham tDCS",[52,57],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":25},"DEVICE","Active Transcranial Direct Current Stimulation (tDCS)","Participants will receive a single session of active transcranial direct current stimulation (tDCS). Anodal stimulation will be applied over FCz with the cathodal electrode positioned over Fp2 using 5 × 7 cm electrodes. Current will be gradually increased to 2.0 mA, maintained for 30 minutes, and gradually reduced at the end of stimulation.",[40],{"type":53,"name":46,"description":58,"armGroupLabels":59,"otherNames":25},"Participants will receive a single session of sham transcranial direct current stimulation (tDCS). Anodal stimulation will be applied over FCz with the cathodal electrode positioned over Fp2 using 5 × 7 cm electrodes. An initial ramp and brief period of stimulation will reproduce the initial sensations associated with tDCS, followed by automatic discontinuation of sustained current. Session will stop in 30 minutes.",[46],[61],{"name":62,"role":63,"phone":64,"phoneExt":25,"email":65},"Frederico Barreto Kochem, PT, Ph.D.","CONTACT","+55 24 98156-9166","frederico_kochem@hotmail.com",[67],{"facility":68,"status":25,"city":69,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Orquestra Maré do Amanhã","Rio de Janeiro","21042-432","Brazil","BR",{"type":74,"coordinates":75},"Point",[76,77],-43.18223,-22.90642,{"lat":77,"lon":76},[80,81,84,86,89],{"name":62,"role":63,"phone":64,"phoneExt":25,"email":65},{"name":82,"role":83,"phone":25,"phoneExt":25,"email":25},"Frederico Barreto Kochem, PT, PhD","PRINCIPAL_INVESTIGATOR",{"name":85,"role":83,"phone":25,"phoneExt":25,"email":25},"Débora Cristina Lima da Silva, PT, PhD",{"name":87,"role":88,"phone":25,"phoneExt":25,"email":25},"Ricardo Galhardoni, PhD","SUB_INVESTIGATOR",{"name":90,"role":88,"phone":25,"phoneExt":25,"email":25},"Renato Santos de Almeida, PT, PhD",{"type":83,"investigatorFullName":92,"investigatorTitle":93,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Frederico Barreto Kochem","Principal Investigator and Professor at Centro Universitário Augusto Motta (UNISUAM)",[95],{"name":96,"class":6},"Neuromodulacao em Foco","100656467","safety-and-acute-effects-of-tdcs-on-musical-performance-in-adolescent-musicians-100656467",false,"NCT07826923","Safety and Acute Effects of tDCS on Musical Performance in Adolescent Instrumentalists","Safety, Tolerability, and Acute Effects of Transcranial Direct Current Stimulation on Technical, Expressive, and Stage Aspects of Musical Performance in Instrumentalists 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 instrumental music training for at least 12 months.\n* Ability to safely perform a previously learned instrumental musical piece or excerpt lasting approximately 1 to 2 minutes.\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, or relevant sleep deprivation, when these findings justify postponement or exclusion for safety reasons.",true,"ALL","12 Years","16 Years",{"count":109,"type":110},24,"ESTIMATED","INTERVENTIONAL",[113],"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 musical performance in adolescent instrumentalists aged 12 to 16 years. Twenty-four participants will be randomly assigned to active or sham tDCS. Active stimulation will consist of 2.0 mA anodal tDCS applied for 30 minutes using 5 × 7 cm electrodes positioned over FCz and Fp2. Participants will perform the same previously learned instrumental musical piece or excerpt before stimulation, immediately after stimulation, and two hours after stimulation. Musical performances will be evaluated by blinded expert raters using a standardized performance rubric. Safety and tolerability will be monitored using a structured symptom checklist and predefined stopping criteria. Self-rated performance, nervousness, confidence, blinding, and protocol feasibility will also be explored.",[116,117],"Musical Performance","Neuromodulation",[119,120,121,122,123,124,125],"Transcranial Direct Current Stimulation","Adolescent","Music Performance","Instrumental Musicians","Safety","Tolerability","Motor Performance","NOT_YET_RECRUITING","2026-09-30",{"date":129,"type":130},"2026-10-05","ACTUAL",{"date":132,"type":110},"2026-10-07",{"date":134,"type":110},"2026-12-31",{"name":5,"class":6},1]