Safety and Acute Effects of tDCS on Musical Performance in Adolescent Instrumentalists
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-16
SponsorCentro Universitário Augusto Motta
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Active Transcranial Direct Current Stimulation (tDCS)
DeviceParticipants 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 tDCS
DeviceParticipants 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.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Active tDCSExperimental treatment 1 intervention
Group B: Sham tDCSSham comparator 1 intervention
Trial outcomes
Primary outcomes
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.
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.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.
Time frame
Baseline, immediately after intervention, and 2 hours after interventionSecondary outcomes
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.
Time frame
Baseline, immediately after intervention, and 2 hours after intervention2
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.
Time frame
At the end of the study session, approximately 2 hours after interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Centro Universitário Augusto Motta
Lead sponsor
Neuromodulacao em Foco
Collaborator
Source ClinicalTrials.gov
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