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

NCT07826923 | Not Yet Recruiting

• 1 other identifier: 01375026.7.0000.5235
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Musical Performance; Neuromodulation

Keywords

Transcranial Direct Current Stimulation; Adolescent; Music Performance; Instrumental Musicians; Singers; Safety; Tolerability; Motor Performance

Outcome Measures

Primary Outcomes (2)

• 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/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

  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

Secondary Outcomes (2)

• Change in Self-Reported Musical Performance

  Baseline, immediately after intervention, and 2 hours after intervention

• Participant Perception of Intervention Allocation

  At the end of the study session, approximately 2 hours after intervention

Study Arms (2)

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.

Device: Active Transcranial Direct Current Stimulation (tDCS)

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.

Device: Sham tDCS

Interventions

Active Transcranial Direct Current Stimulation (tDCS) DEVICE

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.

Active tDCS

Sham tDCS DEVICE

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.

Sham tDCS

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro Universitário Augusto Motta: lead
• Neuromodulacao em Foco: collaborator

Study Sites (1)

Orquestra Maré do Amanhã

Rio de Janeiro, Rio de Janeiro, 21042-432, Brazil

Location

Related Publications (6)

• 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.

  PMID: 41622107 BACKGROUND

• 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.

  PMID: 30327622 BACKGROUND

• 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.

  PMID: 25297109 BACKGROUND

• 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.

  PMID: 27372845 BACKGROUND

• 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.

  PMID: 25468234 BACKGROUND

• 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.

  PMID: 33578648 BACKGROUND

Central Study Contacts

Frederico Barreto Kochem, PT, Ph.D.

CONTACT

+55 24 98156-9166; frederico_kochem@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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. The allocation code will remain concealed until completion of data collection and blinded outcome assessment, except when unblinding is required for participant safety.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Professor at Centro Universitário Augusto Motta (UNISUAM)

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 17, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 17, 2026

Record last verified: 2026-09

Locations

BR (1)