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

2026年10月7日 更新者:Frederico Barreto Kochem、Centro Universitário Augusto Motta

Safety, Tolerability, and Acute Effects of Transcranial Direct Current Stimulation on Vocal Performance in Adolescent Singers 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 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.

研究概览

详细说明

This randomized parallel-group pilot study will evaluate the safety, tolerability, and acute effects of transcranial direct current stimulation (tDCS) in adolescent singers 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 20 minutes using 5 × 7 cm electrodes, with the anode positioned over C5 to target the left laryngeal primary motor cortex and the cathode positioned over the right supraorbital region. The sham condition will use the same electrode montage and overall session duration and will reproduce the initial sensations associated with stimulation without sustained current delivery.

Participants will perform the same standardized vocal piece, "Repousa Participants will perform the same standardized vocal piece, "Repousa tranquillo, O meigo Jesus (Lullaby for Baby Jesus)," a traditional Brazilian song listed in ABRSM Singing Grade 2, List A, in G minor, arranged by Hargest Jones and published in Songs of Christmas (Boosey & Hawkes), 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 an adapted analytical vocal-performance rubric based on Gynnild (2015). The rubric evaluates Technique, Language/Text, Musicality, Ability to Communicate, and Choice of Repertoire using grades A through F converted to numerical values from 5 to 0. Because repertoire is standardized by the protocol, the Choice of Repertoire domain will not contribute to the primary vocal-performance score.

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 vocal 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 singers.

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.

研究类型

介入性

注册 (估计的)

24

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Rio de Janeiro
      • Rio de Janeiro、Rio de Janeiro、巴西、21042-432
        • Orquestra Maré do Amanhã
        • 首席研究员:
          • Frederico Barreto Kochem, PT, PhD
        • 首席研究员:
          • Débora Cristina Lima da Silva, PT, PhD
        • 副研究员:
          • Ricardo Galhardoni, PhD
        • 副研究员:
          • Renato Santos de Almeida, PT, PhD
        • 接触:
        • 副研究员:
          • Rômulo de Freitas Santos Nicolai, BMus (Classical Voice), MMus

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

12年 至 16年 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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, relevant sleep deprivation, or acute upper respiratory symptoms when these findings justify postponement or exclusion for safety or performance-related reasons.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
实验性的:Active tDCS

Participants will receive a single 20-minute session of active transcranial direct current stimulation (tDCS) at 2.0 mA using 5 × 7 cm electrodes, with the anode positioned over C5 to target the left laryngeal primary motor cortex and the cathode positioned over the right supraorbital region.

Participants 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.

假比较器:Sham tDCS

Participants will receive a single 20-minute sham tDCS session using the same electrode montage as the active condition. Sham stimulation will reproduce the initial sensations associated with tDCS through an initial ramp-up and brief stimulation period, without sustained current delivery.

Participants 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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Incidence and Severity of Treatment-Emergent Adverse Events Associated With Transcranial Direct Current Stimulation
大体时间:Baseline (pre-stimulation); during the 20-minute stimulation session; immediately post-stimulation; 2 hours post-stimulation; and approximately 24 hours post-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.

Baseline (pre-stimulation); during the 20-minute stimulation session; immediately post-stimulation; 2 hours post-stimulation; and approximately 24 hours post-stimulation.
Change in Vocal Performance Scores
大体时间:Baseline, immediately after intervention, and 2 hours after intervention

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.

Baseline, immediately after intervention, and 2 hours after intervention
Change in Vocal Performance Scores
大体时间:Baseline, immediately after intervention, and 2 hours after intervention

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.

Baseline, immediately after intervention, and 2 hours after intervention

次要结果测量

结果测量
措施说明
大体时间
Change in Self-Reported Vocal Performance
大体时间:Baseline, immediately after intervention, and 2 hours after intervention

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.

Baseline, immediately after intervention, and 2 hours after intervention
Change in Self-Reported Nervousness
大体时间:Baseline, immediately after intervention, and 2 hours after intervention

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.

Baseline, immediately after intervention, and 2 hours after intervention
Change in Self-Reported Confidence
大体时间:Baseline, immediately after intervention, and 2 hours after intervention

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.

Baseline, immediately after intervention, and 2 hours after intervention
Participant Perception of Intervention Allocation
大体时间:At the end of the study session, approximately 2 hours after intervention

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.

At the end of the study session, approximately 2 hours after intervention
Completion Rate
大体时间:From enrollment through completion of the 2-hour post-intervention assessment

Completion rate will be calculated as the proportion of enrolled participants who complete all planned study procedures, including baseline assessment, the assigned tDCS or sham session, immediate post-intervention assessment, and the 2-hour post-intervention assessment. The number and percentage of participants completing the full study protocol will be reported.

From enrollment through completion of the 2-hour post-intervention assessment
Protocol Adherence
大体时间:From enrollment through completion of the 2-hour post-intervention assessment.

Protocol adherence will be assessed as the proportion of enrolled participants who complete the assigned stimulation session and all planned study assessments according to the predefined protocol without major protocol deviations. The number and percentage of participants with complete adherence will be reported, and protocol deviations will be documented.

From enrollment through completion of the 2-hour post-intervention assessment.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月7日

初级完成 (估计的)

2026年12月30日

研究完成 (估计的)

2026年12月31日

研究注册日期

首次提交

2026年9月30日

首先提交符合 QC 标准的

2026年9月30日

首次发布 (实际的)

2026年10月6日

研究记录更新

最后更新发布 (实际的)

2026年10月13日

上次提交的符合 QC 标准的更新

2026年10月7日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • 01375026.7.0000.5235-VOCAL

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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