- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06958081
- Original Trial
tDCS and Musical Performance in Young Orchestra Musicians
Acute Effects of Transcranial Direct Current Stimulation on Technical, Expressive, and Scenic Aspects of Musical Performance in Young Orchestra Instrumentalists: A Proof-of-Concept Study
The goal of this clinical trial is to learn if transcranial direct current stimulation (tDCS) can improve the technical, expressive, and stage aspects of musical performance in young orchestra musicians aged 18 to 30 years. The main questions it aims to answer are:
- Does active tDCS improve musical performance compared to sham stimulation?
- Does active tDCS reduce music performance anxiety and increase musical self-efficacy? Researchers will compare the active tDCS group to the sham stimulation group to see if active stimulation has positive effects on musical performance and psychological factors.
Participants will:
- Receive either active or sham tDCS stimulation
- Perform a musical piece before and after stimulation
- Complete questionnaires about anxiety and musical self-confidence
Study Overview
Status
Detailed Description
This randomized pilot study aims to investigate the acute effects of transcranial direct current stimulation (tDCS) on the technical, expressive, and stage aspects of musical performance in young orchestra instrumentalists.
A total of 24 musicians, aged 18 to 30 years, with at least three years of orchestral experience, will be randomly assigned to either an active tDCS group or a sham stimulation group. The stimulation will target the supplementary motor area (SMA) using a 2.0 mA anodal current for 30 minutes, with the cathode placed over Fp2. The sham group will undergo the same electrode placement, but the current will be turned off after 30 seconds.
The study will adopt a double-blind design, where neither participants, care providers, investigators, nor outcome assessors will know the group allocations. Each participant will perform a standardized musical piece before and after the intervention, and after a 2-hour interval post-intervention. Performances will be recorded and evaluated by independent expert judges using the Rubric for the Assessment of Music Performance Achievement.
Psychometric evaluations will be conducted using the Mazzarolo Music Performance Anxiety Scale (M-MPAS) and the General Musical Self-Efficacy Scale. Self-assessments of performance and sensations during stimulation will also be collected. Data analysis will compare changes in musical performance, anxiety, and self-efficacy between groups.
This study seeks to provide preliminary evidence on the potential of tDCS to enhance musical performance and psychological factors such as performance anxiety and self-confidence among young musicians. Safety and feasibility of the intervention will also be monitored throughout the study.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rio de Janeiro
-
Rio de Janeiro, Rio de Janeiro, Brazil, 21041-010
- Centro Universitário Augusto Motta (UNISUAM)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Musicians aged 18 to 30 years.
- Minimum of 3 years of orchestral performance experience.
- Active participation in a stable orchestra or ensemble.
- No history of neurological or psychiatric disorders.
- Not currently using psychotropic medications or recreational drugs.
- Willingness to participate in all study sessions.
- Signed informed consent form.
Exclusion Criteria:
- Presence of metallic implants in the head (e.g., cranial pins, aneurysm clips).
- Presence of implanted electronic devices (e.g., pacemaker).
- History of epilepsy or seizures.
- Prior experience with transcranial direct current stimulation (tDCS).
- Scalp dermatitis or lesions at the electrode placement sites.
- Pregnancy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Active tDCS
Participants will receive active transcranial direct current stimulation (tDCS) with a 2.0 mA anodal current applied over the supplementary motor area (FCz) and cathodal electrode over Fp2 for 30 minutes.
|
2.0 mA anodal stimulation applied over FCz with cathode over Fp2 for 30 minutes using a transcranial direct current stimulation device.
|
|
Sham Comparator: Sham tDCS
Participants will receive sham transcranial direct current stimulation (tDCS) with the same electrode placement as the active group; however, the current will be turned off after 30 seconds to simulate the initial sensations without delivering prolonged stimulation.
|
Sham stimulation mimicking the sensations of tDCS; the current will be turned off after 30 seconds while maintaining electrode placement over FCz and Fp2.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Musical Performance Scores (Rubric for the Assessment of Music Performance Achievement)
Time Frame: Baseline, immediately after intervention, and 2 hours after intervention
|
Musical performance will be evaluated by independent expert judges using a standardized rubric assessing technical, expressive, and stage presence aspects.
|
Baseline, immediately after intervention, and 2 hours after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Self-Reported Musical Performance Score (0-10 scale)
Time Frame: Baseline, immediately after intervention, and 2 hours after intervention
|
Participants will self-rate the quality of their musical performance on a 0 (worst) to 10 (best) scale after each recording session.
|
Baseline, immediately after intervention, and 2 hours after intervention
|
|
Perception of Intervention Received (Active or Sham)
Time Frame: Immediately after intervention
|
Participants will report whether they believe they received active stimulation or sham stimulation, to assess effectiveness of blinding.
|
Immediately after intervention
|
|
Music Performance Anxiety (Mazzarolo Music Performance Anxiety Scale - M-MPAS)
Time Frame: Baseline
|
Participants' levels of music performance anxiety will be assessed using the Mazzarolo Music Performance Anxiety Scale (M-MPAS), a validated 5-item instrument designed to measure cognitive, somatic, and behavioral symptoms of performance anxiety in musicians.
Each item is rated on a 7-point Likert scale (0-6), with a total score range from 0 to 30 points.
Higher scores indicate greater levels of anxiety, with scores ≥11 suggesting a tendency toward elevated performance anxiety.
|
Baseline
|
|
Musical Self-Efficacy (General Musical Self-Efficacy Scale)
Time Frame: Baseline
|
Musical self-efficacy will be assessed using the performance subscale of the General Musical Self-Efficacy Scale, composed of 11 items rated on a 7-point Likert scale ranging from 1 ("Strongly disagree") to 7 ("Strongly agree").
The total score ranges from 11 to 77, with higher scores indicating greater self-efficacy in musical performance contexts.
|
Baseline
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ricardo Galhardoni, Ph.D, Neuromodulação em Foco
- Study Chair: Renato Santos de Almeida, Ph.D, Centro Universitário Augusto Motta
- Principal Investigator: Débora Cristina Lima da Silva, Ph.D, Centro Universitário Augusto Motta
Publications and helpful links
General Publications
- 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.
- Álvarez-Díaz M, Muñiz-Bascón LM, Soria-Alemany A, Veintimilla-Bonet A, Fernández-Alonso R. On the design and validation of a rubric for the evaluation of performance in a musical contest. International Journal of Music Education. 2021;39(1):66-79. doi:10.1177/0255761420936443
- Mazzarolo I, Schubert E. A Short Performance Anxiety Scale for Musicians. Front Psychol. 2022 Jan 26;12:781262. doi: 10.3389/fpsyg.2021.781262. eCollection 2021.
- Sanchez-Kuhn A, Perez-Fernandez C, Canovas R, Flores P, Sanchez-Santed F. Transcranial direct current stimulation as a motor neurorehabilitation tool: an empirical review. Biomed Eng Online. 2017 Aug 18;16(Suppl 1):76. doi: 10.1186/s12938-017-0361-8.
- 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.
- Chinzara TT, Buckingham G, Harris DJ. Transcranial direct current stimulation and sporting performance: A systematic review and meta-analysis of transcranial direct current stimulation effects on physical endurance, muscular strength and visuomotor skills. Eur J Neurosci. 2022 Jan;55(2):468-486. doi: 10.1111/ejn.15540. Epub 2022 Jan 6.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 88146925.0.0000.5235
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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