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Safety and Acute Effects of tDCS on Musical Performance in Adolescent Musicians

16. september 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

30

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Brasil
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brasil, 21042-432
        • Orquestra Maré do Amanhã
        • Ta kontakt med:
        • Hovedetterforsker:
          • Frederico Barreto Kochem, PT, PhD
        • Hovedetterforsker:
          • Débora Cristina Lima da Silva, PT, PhD
        • Underetterforsker:
          • Ricardo Galhardoni, PhD
        • Underetterforsker:
          • Renato Santos de Almeida, PT, PhD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Ja

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: 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.
Sham-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.
Enhet: Sham tDCS
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Safety and Tolerability of Transcranial Direct Current Stimulation
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Self-Reported Musical Performance
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Centro Universitário Augusto Motta

Samarbeidspartnere

Neuromodulacao em Foco

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. oktober 2026

Primær fullføring (Antatt)

30. desember 2026

Studiet fullført (Antatt)

31. desember 2026

Datoer for studieregistrering

Først innsendt

11. september 2026

Først innsendt som oppfylte QC-kriteriene

16. september 2026

Først lagt ut (Faktiske)

17. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 01375026.7.0000.5235

Plan for individuelle deltakerdata (IPD)

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