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Musical PerformanceNCT07826923

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

A study testing Active Transcranial Direct Current Stimulation (tDCS) in people with Musical Performance and Neuromodulation, run by Centro Universitário Augusto Motta at 1 site in Brazil.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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 aged 12 to 16 years. Twenty-four participants will be randomly assigned to active or sham tDCS. Read more about this study

Who is it for?
Ages 12 to 16 yearsHealthy volunteers can take part
Conditions the study is for
Musical Performance, Neuromodulation
What is being tested?
Active Transcranial Direct Current Stimulation (tDCS)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteBrazil
Study dates
7 Oct 2026to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Age 12 to 16 years, inclusive, at the time of enrollment.
  • Regular participation in instrumental music training for at least 12 months.
  • Ability to safely perform a previously learned instrumental 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Frederico Barreto Kochem, PT, Ph.D. contact

+55 24 98156-9166

frederico_kochem@hotmail.com

Brazil1 site
  • Orquestra Maré do Amanhã

    Rio de Janeiro, Rio de Janeiro, 21042-432

    Frederico Barreto Kochem, PT, Ph.D., +55 24 98156-9166, frederico_kochem@hotmail.com

    Frederico Barreto Kochem, PT, PhD

Other trials in Brazil

About this study

Official title: 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

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.

Read the detailed description

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.

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 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.

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 instrumentalists.

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.

Being tested
Active Transcranial Direct Current Stimulation (tDCS), Sham tDCS
Keywords
Transcranial Direct Current Stimulation, Adolescent, Music Performance, Instrumental Musicians, Safety, Tolerability, Motor Performance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • Sham tDCSDevice

    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.

Study groups in NCT07826923
Study groupRoleWhat they receive
Active tDCSExperimentalParticipants 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.
Receives: Device: Active Transcranial Direct Current Stimulation (tDCS)
Sham tDCSSham comparatorSham 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.
Receives: Device: Sham tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (pre-stimulation); periprocedural (throughout the 30-minute stimulation session); immediately post-stimulation; 2 hours post-stimulation; and approximately 24 hours post-stimulation.

  2. 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.

    Measured: Baseline, immediately after intervention, and 2 hours after intervention

Secondary outcomes (2)
  1. Change in Self-Reported Musical Performance

    Description:

    Participants 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.

    Measured: Baseline, immediately after intervention, and 2 hours after intervention

  2. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2026
  2. Study start7 Oct 2026 (estimated)
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07826923
Sponsor's protocol ID
01375026.7.0000.5235
Status last verified
Sep 2026
First submitted
11 Sep 2026
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 41622107
  • 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.

    PubMed 30327622
  • 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.

    PubMed 25297109
  • 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.

    PubMed 27372845
  • 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.

    PubMed 25468234
  • 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.

    PubMed 33578648

Questions about this trial

What is this clinical trial studying?

A study testing Active Transcranial Direct Current Stimulation (tDCS) in people with Musical Performance and Neuromodulation, run by Centro Universitário Augusto Motta at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Frederico Barreto Kochem, PT, Ph.D. (+55 24 98156-9166, frederico_kochem@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability of Transcranial Direct Current Stimulation (time frame: Baseline (pre-stimulation); periprocedural (throughout the 30-minute stimulation session); immediately post-stimulation; 2 hours post-stimulation; and approximately 24 hours post-stimulation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07826923, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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