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Completed

NCT Number: NCT06544122

Effect of Transcranial Direct Current Stimulation on the Voice

The goal of this clinical trial is to verify the effect on the voice of transcranial direct current stimulation (tDCS) in vocally healthy non-singers. The main question it aims to answer is: What is the brain area in which tDCS promotes better vocal performance in vocally healthy individuals? Each participants received anodal tDCS applied at an intensity of 2 mA for a duration of 20 minutes for tDCS stimulations in different areas with a 7-day washout period between stimulations. Vocal assessments was conducted before and after the intervention. The targeted places were the primary motor cortex (M1), primary somatosensory cortex (S1), Cerebellum, and dorsolateral prefrontal cortex (DLPFC).

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Key information

Conditions

Voice and Resonance Disorders Communication Disorders Laryngeal Diseases Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Transcranial Direct Current Stimulation Voice Disorders Voice Disturbance

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laboratório de Neurociência Aplicada

Recife, Pernambuco, 50740-560, Brazil

About this study

Recently, non-invasive brain stimulation (NIBS) techniques , including transcranial direct current stimulation (tDCS), have been employed to enhance vocal skills. tDCS can be used to temporarily and reversibly modulate brain functions and is an increasingly popular tool for investigating the relationships between the brain and behavior . The aim of the present study is investigate the effect of tDCS applied to different areas on the voice of vocally healthy non-singers. This is a randomized crossover clinical trial, approved by the Research Ethics Committee of the Federal University of Pernambuco, number 5,758,856. Vocally healthy people from the city of Recife and its Metropolitan Region, aged between 18 and 45 years, participated in the study.Each participant underwent four tDCS stimulations in different areas with a 7-day washout period between stimulations to study their vocal assessments before and after tDCS. The targeted places were the primary motor cortex (M1), primary somatosensory cortex (S1), Cerebellum, and dorsolateral prefrontal cortex (DLPFC). All participants were subjected to voice acessments analysis immediately before and after tDCS application in each area. Data normality will be analyzed using the Shapiro-Wilk test, rejecting the hypothesis of normal distribution when p<0.05. ANOVA will be applied to design repeated measures in case of normality and in the existence of asymmetric data, Friedmann's ANOVA will be used for repeated measures. For the comparison of values before and after application of the technique and between modes of execution of the technique (with and without non-invasive neuromodulation), tests will be applied for related and independent samples, respectively, with a significance level of 5%

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non-singers with healthy voice

Exclusion criteria

  • Smokers
  • Those who present signs and symptoms of laryngeal, pharyngeal or respiratory diseases at the time of collection
  • Volunteers who make regular use of neuroactive drugs
  • Those who have metallic implants or a pacemaker
  • People that have any history of seizures or epilepsy

Treatment and study plan

Transcranial Direct Current Stimulation

Device

Anodal tDCS will be applied at an intensity of 2mA and duration of 20 minutes. The assembly of the electrodes during the tDCS sessions will be carried out as follows: primary motor cortex, the stimulation electrode (anode) will be positioned on C5 (international EEG 10-20 system), in S1 (2cm posterior to C5), at the PFCDL (Fp3), all with the cathode positioned on the region contralateral supraorbital. For cerebellar tDCS the anode will be positioned on the inion area and the cathode on the deltoide muscle.

Other names: tDCS, transcranial electrical stimulation, anodal stimulation tDCS

Primary outcomes

  1. Vocal range profile

    Time frame: through study completion, an average of 6 months

    Min f0 (Hz) Max f0 (Hz) Ext f0 (Hz) Ext (ST) Mín int (dB) Max int (dB) Area (%)

    Min f0 (Hz) Max f0 (Hz) Ext f0 (Hz) Ext (ST) Mín int (dB) Max int (dB) Area (%)

    Minimum f0 (Hz); Maximum f0 (Hz); Extension f0; Extension in St; Minimum intensity (dB); Maximum intensity (dB); Area (%)

Secondary outcomes

  1. Voice

    Time frame: through study completion, an average of 6 months

    Jitter (%); Shimmer (%); Irregularity; GNE; DAI

  2. Laryngeal diadochokinesis

    Time frame: through study completion, an average of 6 months

    Change in the task of producing vowels separately, with rapid repetition of each vowel as quickly as possible for eight seconds

  3. Vocal effort

    Time frame: through study completion, an average of 6 months

    The Adapted Borg CR10 for Vocal Effort Ratings (BR) maintained a scale from 0 to 10, where 0 means "no vocal effort at all", and 10 "maximum vocal effort". First, the participants have to reproduce a note played on a virtual keyboard (3 tones below their maximum glissando frequency) and sustain the note while counting from 21 to 30, immediately afterwards, the participants answered the Adapted Borg CR10 for Vocal Effort Ratings (BR).

Sponsors and collaborators

Lead sponsor

Universidade Federal de Pernambuco

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Aug 9, 2024
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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