Safety and Acute Effects of tDCS on Musical Performance in Adolescent Musicians
16 septembre 2026 mis à jour par: Frederico Barreto Kochem, Centro Universitário Augusto Motta
Safety, Tolerability, and Acute Effects of Transcranial Direct Current Stimulation on Technical, Expressive, and Stage Aspects of Musical Performance in Instrumentalists and Singers Aged 12 to 16 Years: A Randomized Sham-Controlled Proof-of-Concept Study
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 and singers 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 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
This randomized parallel-group pilot study will evaluate the safety, tolerability, and acute effects of transcranial direct current stimulation (tDCS) in adolescent musicians aged 12 to 16 years, including both instrumentalists and singers.
Twenty-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.
Participants will perform the same previously learned 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.
Participants 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 musicians.
Written 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.
Type d'étude
Interventionnel
Inscription (Estimé)
30
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Frederico Barreto Kochem, PT, Ph.D.
- Numéro de téléphone: +55 24 98156-9166
- E-mail: frederico_kochem@hotmail.com
Lieux d'étude
-
-
Rio de Janeiro
-
Rio de Janeiro, Rio de Janeiro, Brésil, 21042-432
- Orquestra Maré do Amanhã
-
Contact:
- Frederico Barreto Kochem, PT, Ph.D.
- Numéro de téléphone: +55 24 98156-9166
- E-mail: frederico_kochem@hotmail.com
-
Chercheur principal:
- Frederico Barreto Kochem, PT, PhD
-
Chercheur principal:
- Débora Cristina Lima da Silva, PT, PhD
-
Sous-enquêteur:
- Ricardo Galhardoni, PhD
-
Sous-enquêteur:
- Renato Santos de Almeida, PT, PhD
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
Oui
La description
Inclusion Criteria:
- Age 12 to 16 years, inclusive, at the time of enrollment.
- Regular participation in instrumental or vocal music training for at least 12 months.
- Ability to safely perform a previously learned musical piece or excerpt lasting approximately 1 to 2 minutes.
- General health status compatible with participation, confirmed through a pre-session safety screening.
- No known neurological or clinical condition considered to increase the risk associated with stimulation.
- No current use of medication or substances considered by the study team to substantially alter cortical excitability or increase procedural risk.
- Written informed consent from a legal guardian.
- Written assent from the adolescent and voluntary willingness to participate.
Exclusion Criteria:
- History of epilepsy or non-febrile seizures.
- Relevant brain injury, previous cranial surgery, or other neurological condition considered incompatible with the protocol.
- Pacemaker, implanted electronic device, neurostimulator, or cranial metallic implant that could pose a risk or interfere with stimulation.
- Current use of anticonvulsant medication or other medication considered by the study team to represent a contraindication or unacceptable precaution.
- Previous experience with tDCS when such experience could compromise blinding.
- Dermatitis, wounds, infection, burns, significant pain, or other scalp abnormalities at the planned electrode sites.
- Known or suspected pregnancy, as a precaution; pregnancy testing will not be performed as part of the study.
- 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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Active tDCS
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.
|
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.
|
|
Comparateur factice: Sham tDCS
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.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Safety and Tolerability of Transcranial Direct Current Stimulation
Délai: Baseline (pre-stimulation); periprocedural (throughout the 30-minute stimulation session); immediately post-stimulation; 2 hours post-stimulation; and approximately 24 hours post-stimulation.
|
Safety and tolerability will be assessed using a structured checklist documenting the presence and intensity of tingling/itching, 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.
|
|
Change in Musical Performance Scores
Délai: Baseline, immediately after intervention, and 2 hours after intervention
|
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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Self-Reported Musical Performance
Délai: Baseline, immediately after intervention, and 2 hours after intervention
|
Participants will rate their own 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.
|
Baseline, immediately after intervention, and 2 hours after intervention
|
|
Participant Perception of Intervention Allocation
Délai: At the end of the study session, approximately 2 hours after intervention
|
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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Bikson M, Grossman P, Thomas C, Zannou AL, Jiang J, Adnan T, Mourdoukoutas AP, Kronberg G, Truong D, Boggio P, Brunoni AR, Charvet L, Fregni F, Fritsch B, Gillick B, Hamilton RH, Hampstead BM, Jankord R, Kirton A, Knotkova H, Liebetanz D, Liu A, Loo C, Nitsche MA, Reis J, Richardson JD, Rotenberg A, Turkeltaub PE, Woods AJ. Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Brain Stimul. 2016 Sep-Oct;9(5):641-661. doi: 10.1016/j.brs.2016.06.004. Epub 2016 Jun 15.
- Moliadze V, Schmanke T, Andreas S, Lyzhko E, Freitag CM, Siniatchkin M. Stimulation intensities of transcranial direct current stimulation have to be adjusted in children and adolescents. Clin Neurophysiol. 2015 Jul;126(7):1392-9. doi: 10.1016/j.clinph.2014.10.142. Epub 2014 Oct 28.
- Anic A, Olsen KN, Thompson WF. Investigating the Role of the Primary Motor Cortex in Musical Creativity: A Transcranial Direct Current Stimulation Study. Front Psychol. 2018 Oct 1;9:1758. doi: 10.3389/fpsyg.2018.01758. eCollection 2018.
- Antal A, Bjekic J, Ganho-Avila A, Alekseichuk I, Assecondi S, Bergmann TO, Bikson M, Brunelin J, Brunoni AR, Charvet L, Chen R, Cohen Kadosh R, Diedrich L, D'Urso G, Ferrucci R, Filipovic SR, Fitzgerald PB, Floel A, Frohlich F, George MS, Hamilton RH, Haueisen J, Hallett M, Herrmann CS, Hummel FC, Jaberzadeh S, Langguth B, Lavidor M, Lefaucheur JP, Miniussi C, Moliadze V, Nikander M, Nikolin S, Nitsche MA, Opitz A, O'Shea J, Padberg F, Plewnia C, Priori A, Ramasawmy P, Razza LB, Rossi S, Rothwell J, Rueger MA, Ruffini G, Sack AT, Salvador R, Schellhorn K, Schuhmann T, Shirota Y, Siebner HR, Thielscher A, Ugawa Y, Uusitalo S, Wexler A, Paulus W, Vanderhasselt MA, Van Waes V, Wessel MJ, Wischnewski M, Baeken C, Ziemann U. Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines (2017-2025: An update) - endorsed by the European Society for Brain Stimulation (ESBS) and by the International Federation for Clinical Neurophysiology (IFCN). Clin Neurophysiol. 2026 Apr;184:2111436. doi: 10.1016/j.clinph.2025.2111436. Epub 2025 Nov 23.
- Furuya S, Klaus M, Nitsche MA, Paulus W, Altenmuller E. Ceiling effects prevent further improvement of transcranial stimulation in skilled musicians. J Neurosci. 2014 Oct 8;34(41):13834-9. doi: 10.1523/JNEUROSCI.1170-14.2014.
- Buchanan DM, Bogdanowicz T, Khanna N, Lockman-Dufour G, Robaey P, D'Angiulli A. Systematic Review on the Safety and Tolerability of Transcranial Direct Current Stimulation in Children and Adolescents. Brain Sci. 2021 Feb 10;11(2):212. doi: 10.3390/brainsci11020212.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 octobre 2026
Achèvement primaire (Estimé)
30 décembre 2026
Achèvement de l'étude (Estimé)
31 décembre 2026
Dates d'inscription aux études
Première soumission
11 septembre 2026
Première soumission répondant aux critères de contrôle qualité
16 septembre 2026
Première publication (Réel)
17 septembre 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
17 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
16 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 01375026.7.0000.5235
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .