Safety, Tolerability, and Acute Effects of Transcranial Direct Current Stimulation on Technical, Expressive, and Stage Aspects of Musical Performance in Instrumentalists and Singers Aged 12 to 16 Years: A Randomized Sham-Controlled Proof-of-Concept Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety and Tolerability of Transcranial Direct Current Stimulation
研究概览
简要总结
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 and singers 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 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.
详细描述
This randomized parallel-group pilot study will evaluate the safety, tolerability, and acute effects of transcranial direct current stimulation (tDCS) in adolescent musicians aged 12 to 16 years, including both instrumentalists and singers.
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 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 musicians.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants, investigators conducting the study sessions, and outcome assessors will remain blinded to treatment allocation. Randomization and stimulation codes will be prepared and managed by an independent researcher who will not participate in participant assessment, intervention delivery, or outcome evaluation. The allocation code will remain concealed until completion of data collection and blinded outcome assessment, except when unblinding is required for participant safety.
入排标准
- 年龄范围
- 12 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 12 to 16 years, inclusive, at the time of enrollment.
- •Regular participation in instrumental or vocal music training for at least 12 months.
- •Ability to safely perform a previously learned 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.
排除标准
- •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.
研究组 & 干预措施
Active tDCS
Participants 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.
干预措施: Active Transcranial Direct Current Stimulation (tDCS) (Device)
Sham tDCS
Sham 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.
干预措施: Sham tDCS (Device)
结局指标
主要结局
Safety and Tolerability of Transcranial Direct Current Stimulation
时间窗: Baseline (pre-stimulation); periprocedural (throughout the 30-minute stimulation session); immediately post-stimulation; 2 hours post-stimulation; and approximately 24 hours post-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.
Change in Musical Performance Scores
时间窗: Baseline, immediately after intervention, and 2 hours after intervention
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.
次要结局
- Change in Self-Reported Musical Performance(Baseline, immediately after intervention, and 2 hours after intervention)
- Participant Perception of Intervention Allocation(At the end of the study session, approximately 2 hours after intervention)
研究者
Frederico Barreto Kochem
Principal Investigator and Professor at Centro Universitário Augusto Motta (UNISUAM)
Centro Universitário Augusto Motta