Voice and Resonance DisordersNCT06544122
Effect of Transcranial Direct Current Stimulation on the Voice
A study testing Transcranial direct current stimulation in people with Voice and Resonance Disorders and Transcranial Direct Current Stimulation, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Voice and Resonance Disorders, Transcranial Direct Current Stimulation, Voice Disturbance
- What is being tested?
- Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Mar 2023to 20 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-singers with healthy voice
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Laboratório de Neurociência Aplicada
Recife, Pernambuco, 50740-560
About this study
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).
Read the 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%
- Being tested
- Transcranial direct current stimulation
- Keywords
- transcranial direct current stimulation, voice, speech therapy
- Medical subject headings
- Voice Disorders, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationDevice
Also called tDCS, transcranial electrical stimulation, anodal stimulation tDCS
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.
| Study group | Role | What they receive |
|---|---|---|
| Effects on voice of M1 tDCS in healthy voice volunteers | Active comparator | The aim of this arm is to verify the effect on the voice of anodal tDCS M1 larynx target. Receives: Device: Transcranial direct current stimulation |
| Effects on voice of S1 tDCS in vocally health volunteers | Active comparator | The aim of this arm is to verify the effect on the voice of anodal tDCS S1 larynx target. Receives: Device: Transcranial direct current stimulation |
| Effects on voice of PFDLC tDCS in vocally health volunteers | Active comparator | The aim of this arm is to verify the effect on the voice of anodal tDCS PFDLC target. Receives: Device: Transcranial direct current stimulation |
| Effects on voice of cerebellum tDCS in vocally health volunteers | Active comparator | The aim of this arm is to verify the effect on the voice of anodal tDCS cerebellum target. Receives: Device: Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vocal range profile
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 (%)
Measured: through study completion, an average of 6 months
Secondary outcomes (3)
Voice
Jitter (%); Shimmer (%); Irregularity; GNE; DAI
Measured: through study completion, an average of 6 months
Laryngeal diadochokinesis
Change in the task of producing vowels separately, with rapid repetition of each vowel as quickly as possible for eight seconds
Measured: through study completion, an average of 6 months
Vocal effort
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).
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start30 Mar 2023
- Primary completion12 Dec 2023
- Study completion20 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Voice and Resonance DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kátia Monte-Silva, Universidade Federal de Pernambuco
- Investigators
- kelly Greyce SC Oliveira, PhD student, Principal investigator, UFPE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544122
- Sponsor's protocol ID
- TDCS_voice
- Status last verified
- Aug 2024
- First submitted
- 9 Jul 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Behroozmand R, Johari K, Bridwell K, Hayden C, Fahey D, den Ouden DB. Modulation of vocal pitch control through high-definition transcranial direct current stimulation of the left ventral motor cortex. Exp Brain Res. 2020 Jun;238(6):1525-1535. doi: 10.1007/s00221-020-05832-9. Epub 2020 May 23.
PubMed 32447409Peng D, Lin Q, Chang Y, Jones JA, Jia G, Chen X, Liu P, Liu H. A Causal Role of the Cerebellum in Auditory Feedback Control of Vocal Production. Cerebellum. 2021 Aug;20(4):584-595. doi: 10.1007/s12311-021-01230-1. Epub 2021 Feb 8.
PubMed 33555544Thair H, Holloway AL, Newport R, Smith AD. Transcranial Direct Current Stimulation (tDCS): A Beginner's Guide for Design and Implementation. Front Neurosci. 2017 Nov 22;11:641. doi: 10.3389/fnins.2017.00641. eCollection 2017.
PubMed 29213226Wang B, Xiao S, Yu C, Zhou J, Fu W. Effects of Transcranial Direct Current Stimulation Combined With Physical Training on the Excitability of the Motor Cortex, Physical Performance, and Motor Learning: A Systematic Review. Front Neurosci. 2021 Apr 9;15:648354. doi: 10.3389/fnins.2021.648354. eCollection 2021.
PubMed 33897361Perikova E, Blagovechtchenski E, Filippova M, Shcherbakova O, Kirsanov A, Shtyrov Y. Anodal tDCS over Broca's area improves fast mapping and explicit encoding of novel vocabulary. Neuropsychologia. 2022 Apr 15;168:108156. doi: 10.1016/j.neuropsychologia.2022.108156. Epub 2022 Jan 10.
PubMed 35026217Cardoso NSV, Lucena JA, de Lira ZS, de Vasconcelos SJ, Lopes LW, Gomes AOC. Do Flexible Silicone Tubes Immersed in Water Combined With Vocalise Improve the Immediate Effect on Voice? J Speech Lang Hear Res. 2021 Dec 13;64(12):4535-4562. doi: 10.1044/2021_JSLHR-20-00629. Epub 2021 Nov 11.
PubMed 34762812
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcranial Direct Current Stimulation on the Voice
- ClinicalTrials.gov ID
- NCT06544122
- Acronym / sponsor ID
- TDCS_voice
- Keywords
- transcranial direct current stimulation, voice, speech therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 20 Apr 2024 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Effects on voice of M1 tDCS in healthy voice volunteers | Active comparator | Device: Transcranial direct current stimulationThe aim of this arm is to verify the effect on the voice of anodal tDCS M1 larynx target. |
| Effects on voice of S1 tDCS in vocally health volunteers | Active comparator | Device: Transcranial direct current stimulationThe aim of this arm is to verify the effect on the voice of anodal tDCS S1 larynx target. |
| Effects on voice of PFDLC tDCS in vocally health volunteers | Active comparator | Device: Transcranial direct current stimulationThe aim of this arm is to verify the effect on the voice of anodal tDCS PFDLC target. |
| Effects on voice of cerebellum tDCS in vocally health volunteers | Active comparator | Device: Transcranial direct current stimulationThe aim of this arm is to verify the effect on the voice of anodal tDCS cerebellum target. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Non-singers with healthy voice
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial direct current stimulationAlso: tDCS, transcranial electrical stimulation, anodal stimulation tDCSAnodal 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. | Device | Effects on voice of M1 tDCS in healthy voice volunteers, Effects on voice of PFDLC tDCS in vocally health volunteers, Effects on voice of S1 tDCS in vocally health volunteers, Effects on voice of cerebellum tDCS in vocally health volunteers |
Primary outcome
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 (%)
3 secondary outcomes
Voice
Time frame: through study completion, an average of 6 months
Laryngeal diadochokinesis
Time frame: through study completion, an average of 6 months
Vocal effort
Time frame: through study completion, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Background: PubMed 32447409Behroozmand R, Johari K, Bridwell K, Hayden C, Fahey D, den Ouden DB. Modulation of vocal pitch control through high-definition transcranial direct current stimulation of the left ventral motor cortex. Exp Brain Res. 2020 Jun;238(6):1525-1535. doi: 10.1007/s00221-020-05832-9. Epub 2020 May 23.
- Background: PubMed 33555544Peng D, Lin Q, Chang Y, Jones JA, Jia G, Chen X, Liu P, Liu H. A Causal Role of the Cerebellum in Auditory Feedback Control of Vocal Production. Cerebellum. 2021 Aug;20(4):584-595. doi: 10.1007/s12311-021-01230-1. Epub 2021 Feb 8.
- Background: PubMed 29213226Thair H, Holloway AL, Newport R, Smith AD. Transcranial Direct Current Stimulation (tDCS): A Beginner's Guide for Design and Implementation. Front Neurosci. 2017 Nov 22;11:641. doi: 10.3389/fnins.2017.00641. eCollection 2017.
- Background: PubMed 33897361Wang B, Xiao S, Yu C, Zhou J, Fu W. Effects of Transcranial Direct Current Stimulation Combined With Physical Training on the Excitability of the Motor Cortex, Physical Performance, and Motor Learning: A Systematic Review. Front Neurosci. 2021 Apr 9;15:648354. doi: 10.3389/fnins.2021.648354. eCollection 2021.
- Background: PubMed 35026217Perikova E, Blagovechtchenski E, Filippova M, Shcherbakova O, Kirsanov A, Shtyrov Y. Anodal tDCS over Broca's area improves fast mapping and explicit encoding of novel vocabulary. Neuropsychologia. 2022 Apr 15;168:108156. doi: 10.1016/j.neuropsychologia.2022.108156. Epub 2022 Jan 10.
- Background: PubMed 34762812Cardoso NSV, Lucena JA, de Lira ZS, de Vasconcelos SJ, Lopes LW, Gomes AOC. Do Flexible Silicone Tubes Immersed in Water Combined With Vocalise Improve the Immediate Effect on Voice? J Speech Lang Hear Res. 2021 Dec 13;64(12):4535-4562. doi: 10.1044/2021_JSLHR-20-00629. Epub 2021 Nov 11.
- Immediate Effect of a Resonance Tube on the Vocal Range Profile of ChoristersLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
kelly Greyce SC Oliveira, PhD student principal investigator
UFPE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation in people with Voice and Resonance Disorders and Transcranial Direct Current Stimulation, run by Universidade Federal de Pernambuco at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vocal range profile (time frame: through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06544122, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.