Safety and Acute Effects of tDCS on Musical Performance in Adolescent Musicians
16. September 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
30
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Frederico Barreto Kochem, PT, Ph.D.
- Telefonnummer: +55 24 98156-9166
- E-Mail: frederico_kochem@hotmail.com
Studienorte
-
-
Rio de Janeiro
-
Rio de Janeiro, Rio de Janeiro, Brasilien, 21042-432
- Orquestra Maré do Amanhã
-
Kontakt:
- Frederico Barreto Kochem, PT, Ph.D.
- Telefonnummer: +55 24 98156-9166
- E-Mail: frederico_kochem@hotmail.com
-
Hauptermittler:
- Frederico Barreto Kochem, PT, PhD
-
Hauptermittler:
- Débora Cristina Lima da Silva, PT, PhD
-
Unterermittler:
- Ricardo Galhardoni, PhD
-
Unterermittler:
- Renato Santos de Almeida, PT, PhD
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Kind
Akzeptiert gesunde Freiwillige
Ja
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
|
Schein-Komparator: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Safety and Tolerability of Transcranial Direct Current Stimulation
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Self-Reported Musical Performance
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Mitarbeiter
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. Oktober 2026
Primärer Abschluss (Geschätzt)
30. Dezember 2026
Studienabschluss (Geschätzt)
31. Dezember 2026
Studienanmeldedaten
Zuerst eingereicht
11. September 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
16. September 2026
Zuerst gepostet (Tatsächlich)
17. September 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
17. September 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
16. September 2026
Zuletzt verifiziert
1. September 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 01375026.7.0000.5235
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
UNENTSCHIEDEN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .