Safety and Acute Effects of tDCS on Musical Performance in Adolescent Musicians
16 сентября 2026 г. обновлено: Frederico Barreto Kochem, Centro Universitário Augusto Motta
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
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.
Обзор исследования
Статус
Еще не набирают
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
30
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Frederico Barreto Kochem, PT, Ph.D.
- Номер телефона: +55 24 98156-9166
- Электронная почта: frederico_kochem@hotmail.com
Места учебы
-
-
Rio de Janeiro
-
Rio de Janeiro, Rio de Janeiro, Бразилия, 21042-432
- Orquestra Maré do Amanhã
-
Контакт:
- Frederico Barreto Kochem, PT, Ph.D.
- Номер телефона: +55 24 98156-9166
- Электронная почта: frederico_kochem@hotmail.com
-
Главный следователь:
- Frederico Barreto Kochem, PT, PhD
-
Главный следователь:
- Débora Cristina Lima da Silva, PT, PhD
-
Младший исследователь:
- Ricardo Galhardoni, PhD
-
Младший исследователь:
- Renato Santos de Almeida, PT, PhD
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
Принимает здоровых добровольцев
Да
Описание
Inclusion Criteria:
- 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.
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, or relevant sleep deprivation, when these findings justify postponement or exclusion for safety reasons.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Тройной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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.
|
Participants 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.
|
|
Фальшивый компаратор: 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.
|
Participants 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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Safety and Tolerability of Transcranial Direct Current Stimulation
Временное ограничение: 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.
|
Baseline (pre-stimulation); periprocedural (throughout the 30-minute stimulation session); immediately post-stimulation; 2 hours post-stimulation; and approximately 24 hours post-stimulation.
|
|
Change in Musical Performance Scores
Временное ограничение: 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.
|
Baseline, immediately after intervention, and 2 hours after intervention
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Self-Reported Musical Performance
Временное ограничение: Baseline, immediately after intervention, and 2 hours after intervention
|
Participants will rate their own 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.
|
Baseline, immediately after intervention, and 2 hours after intervention
|
|
Participant Perception of Intervention Allocation
Временное ограничение: 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
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Соавторы
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- Bikson M, Grossman P, Thomas C, Zannou AL, Jiang J, Adnan T, Mourdoukoutas AP, Kronberg G, Truong D, Boggio P, Brunoni AR, Charvet L, Fregni F, Fritsch B, Gillick B, Hamilton RH, Hampstead BM, Jankord R, Kirton A, Knotkova H, Liebetanz D, Liu A, Loo C, Nitsche MA, Reis J, Richardson JD, Rotenberg A, Turkeltaub PE, Woods AJ. Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Brain Stimul. 2016 Sep-Oct;9(5):641-661. doi: 10.1016/j.brs.2016.06.004. Epub 2016 Jun 15.
- Moliadze V, Schmanke T, Andreas S, Lyzhko E, Freitag CM, Siniatchkin M. Stimulation intensities of transcranial direct current stimulation have to be adjusted in children and adolescents. Clin Neurophysiol. 2015 Jul;126(7):1392-9. doi: 10.1016/j.clinph.2014.10.142. Epub 2014 Oct 28.
- Anic A, Olsen KN, Thompson WF. Investigating the Role of the Primary Motor Cortex in Musical Creativity: A Transcranial Direct Current Stimulation Study. Front Psychol. 2018 Oct 1;9:1758. doi: 10.3389/fpsyg.2018.01758. eCollection 2018.
- Antal A, Bjekic J, Ganho-Avila A, Alekseichuk I, Assecondi S, Bergmann TO, Bikson M, Brunelin J, Brunoni AR, Charvet L, Chen R, Cohen Kadosh R, Diedrich L, D'Urso G, Ferrucci R, Filipovic SR, Fitzgerald PB, Floel A, Frohlich F, George MS, Hamilton RH, Haueisen J, Hallett M, Herrmann CS, Hummel FC, Jaberzadeh S, Langguth B, Lavidor M, Lefaucheur JP, Miniussi C, Moliadze V, Nikander M, Nikolin S, Nitsche MA, Opitz A, O'Shea J, Padberg F, Plewnia C, Priori A, Ramasawmy P, Razza LB, Rossi S, Rothwell J, Rueger MA, Ruffini G, Sack AT, Salvador R, Schellhorn K, Schuhmann T, Shirota Y, Siebner HR, Thielscher A, Ugawa Y, Uusitalo S, Wexler A, Paulus W, Vanderhasselt MA, Van Waes V, Wessel MJ, Wischnewski M, Baeken C, Ziemann U. Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines (2017-2025: An update) - endorsed by the European Society for Brain Stimulation (ESBS) and by the International Federation for Clinical Neurophysiology (IFCN). Clin Neurophysiol. 2026 Apr;184:2111436. doi: 10.1016/j.clinph.2025.2111436. Epub 2025 Nov 23.
- Furuya S, Klaus M, Nitsche MA, Paulus W, Altenmuller E. Ceiling effects prevent further improvement of transcranial stimulation in skilled musicians. J Neurosci. 2014 Oct 8;34(41):13834-9. doi: 10.1523/JNEUROSCI.1170-14.2014.
- Buchanan DM, Bogdanowicz T, Khanna N, Lockman-Dufour G, Robaey P, D'Angiulli A. Systematic Review on the Safety and Tolerability of Transcranial Direct Current Stimulation in Children and Adolescents. Brain Sci. 2021 Feb 10;11(2):212. doi: 10.3390/brainsci11020212.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
1 октября 2026 г.
Первичное завершение (Оцененный)
30 декабря 2026 г.
Завершение исследования (Оцененный)
31 декабря 2026 г.
Даты регистрации исследования
Первый отправленный
11 сентября 2026 г.
Впервые представлено, что соответствует критериям контроля качества
16 сентября 2026 г.
Первый опубликованный (Действительный)
17 сентября 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
17 сентября 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
16 сентября 2026 г.
Последняя проверка
1 сентября 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- 01375026.7.0000.5235
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕ РЕШЕНО
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .