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 vocal performance in adolescent singers aged 12 to 16 years. Twenty-four participants will be randomly assigned in a 1:1 ratio to active or sham tDCS. Active stimulation will consist of 2.0 mA anodal tDCS applied for 20 minutes using 5 × 7 cm electrodes, with the anode positioned over C5 to target the left laryngeal primary motor cortex and the cathode over the right supraorbital region. Participants will perform the same standardized vocal piece before stimulation, immediately after stimulation, and approximately two hours after stimulation. Vocal performances will be audiovisually recorded and evaluated by blinded expert raters using an adapted analytical vocal-performance rubric based on Gynnild (2015). Safety and tolerability will be monitored using a structured symptom checklist and predefined stopping criteria. Self-rated vocal 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 vocal music training for at least 12 months.
Ability to safely perform the standardized vocal piece selected for the study.
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
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). The anode will be positioned over C5, targeting the left laryngeal primary motor cortex, and the cathode over the right supraorbital region using 5 × 7 cm electrodes. Current will be gradually increased to 2.0 mA, maintained for 20 minutes, and gradually reduced at the end of stimulation.
Sham Transcranial Direct Current Stimulation (tDCS)
DeviceParticipants will receive a single sham transcranial direct current stimulation (tDCS) session using the same electrode montage as the active condition, with the anode positioned over C5 and the cathode over the right supraorbital region using 5 × 7 cm electrodes. An initial ramp-up and brief stimulation period will reproduce the initial sensations associated with tDCS, followed by discontinuation of sustained current. The sham session will have the same overall duration as the active session.
Treatment groups
Trial outcomes
Primary outcomes
Incidence and Severity of Treatment-Emergent Adverse Events Associated With Transcranial Direct Current Stimulation
Treatment-emergent adverse events 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. Symptoms present at baseline will be recorded, and an event will be considered treatment-emergent if it occurs after the start of stimulation or increases in intensity relative to baseline. For each event, severity will be categorized as none, mild, moderate, or severe. Stimulation interruptions, inability to complete the stimulation session, and adverse events requiring additional assessment or care will also be recorded. The number and proportion of participants experiencing each treatment-emergent adverse event, together with its severity, will be reported.
Change in Vocal Performance Scores
Vocal performances will be audiovisually recorded and evaluated by blinded independent expert raters using an adapted analytical vocal-performance rubric based on Gynnild (2015). The rubric evaluates Technique, Language/Text, Musicality, Ability to Communicate, and Choice of Repertoire. Performance grades range from A to F and are converted to numerical values from 5 to 0, with higher scores indicating better vocal performance. Because all participants perform the same standardized repertoire, the Choice of Repertoire domain will not contribute to the primary performance score. The primary vocal-performance score will be calculated as the mean of the four applicable domain scores (Technique, Language/Text, Musicality, and Ability to Communicate), each scored from 0 to 5, resulting in an overall mean score ranging from 0 to 5. Higher scores indicate better vocal performance. Changes over time will be compared between the active and sham groups.
Change in Vocal Performance Scores
Vocal performances will be audiovisually recorded and evaluated by blinded independent expert raters using an adapted analytical vocal-performance rubric based on Gynnild (2015). The rubric evaluates technique, language/text, musicality, ability to communicate, and choice of repertoire. Performance grades range from A to F and are converted to numerical values from 5 to 0, with higher scores indicating better vocal performance. Because all participants perform the same standardized repertoire, the choice-of-repertoire domain will not contribute to the primary performance score. The primary vocal-performance score will be calculated from the applicable rubric domains, and changes over time will be compared between the active and sham groups.
Secondary outcomes
Change in Self-Reported Vocal Performance
Participants will rate their own vocal 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 vocal performance.
Change in Self-Reported Nervousness
Participants will rate their nervousness related to the vocal performance on a numerical rating scale from 0 to 10, where 0 represents no nervousness and 10 represents the highest level of nervousness experienced. Higher scores indicate greater self-reported nervousness.
Change in Self-Reported Confidence
Participants will rate their confidence regarding the vocal performance on a numerical rating scale from 0 to 10, where 0 represents no confidence and 10 represents the highest possible confidence. Higher scores indicate greater self-reported confidence.
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.
Sponsors and contacts
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Centro Universitário Augusto Motta
Lead sponsor
Neuromodulacao em Foco
Collaborator
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