Effect of Transcranial Direct Current Stimulation on the Voice

August 12, 2024 updated by: Kátia Monte-Silva, Universidade Federal de Pernambuco
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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%

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50740-560
        • Laboratório de Neurociência Aplicada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Effects on voice of M1 tDCS in healthy voice volunteers
The aim of this arm is to verify the effect on the voice of anodal tDCS M1 larynx target.
Device: Transcranial direct current stimulation
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
Active Comparator: Effects on voice of S1 tDCS in vocally health volunteers
The aim of this arm is to verify the effect on the voice of anodal tDCS S1 larynx target.
Device: Transcranial direct current stimulation
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
Active Comparator: Effects on voice of PFDLC tDCS in vocally health volunteers
The aim of this arm is to verify the effect on the voice of anodal tDCS PFDLC target.
Device: Transcranial direct current stimulation
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
Active Comparator: Effects on voice of cerebellum tDCS in vocally health volunteers
The aim of this arm is to verify the effect on the voice of anodal tDCS cerebellum target.
Device: Transcranial direct current stimulation
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 (%)
through study completion, an average of 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Voice
Time Frame: through study completion, an average of 6 months
Jitter (%); Shimmer (%); Irregularity; GNE; DAI
through study completion, an average of 6 months
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
through study completion, an average of 6 months
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).
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Federal de Pernambuco

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: kelly Greyce SC Oliveira, PhD student, UFPE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 12, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TDCS_voice

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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