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Safety and Acute Effects of tDCS on Vocal Performance in Adolescent Singers

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Trial flagged as At Risk
Primary endpoint reworded 1 of 3 changed
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Record History

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  1. Primary endpoint(s) modified
    • Site contact updated
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07861490
Lead Sponsor Centro Universitário Augusto Motta
Collaborators: Neuromodulacao em Foco
Conditions
(from sponsor)		 Vocal Performance, Neuromodulation
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov