NCT06544122

Brief 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 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
Last Updated

August 15, 2024

Status Verified

August 1, 2024

Enrollment Period

9 months

First QC Date

July 9, 2024

Last Update Submit

August 12, 2024

Conditions

Keywords

transcranial direct current stimulationvoicespeech therapy

Outcome Measures

Primary Outcomes (1)

  • 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 (%)

    through study completion, an average of 6 months

Secondary Outcomes (3)

  • Voice

    through study completion, an average of 6 months

  • Laryngeal diadochokinesis

    through study completion, an average of 6 months

  • Vocal effort

    through study completion, an average of 6 months

Study Arms (4)

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.

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.

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.

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.

Device: Transcranial direct current stimulation

Interventions

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.

Also known as: tDCS, transcranial electrical stimulation, anodal stimulation tDCS
Effects on voice of M1 tDCS in healthy voice volunteersEffects on voice of PFDLC tDCS in vocally health volunteersEffects on voice of S1 tDCS in vocally health volunteersEffects on voice of cerebellum tDCS in vocally health volunteers

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Non-singers with healthy voice

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratório de Neurociência Aplicada

Recife, Pernambuco, 50740-560, Brazil

Location

Related Publications (6)

  • 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.

    PMID: 32447409BACKGROUND
  • Peng 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.

    PMID: 33555544BACKGROUND
  • Thair 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.

    PMID: 29213226BACKGROUND
  • Wang 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.

    PMID: 33897361BACKGROUND
  • Perikova 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.

    PMID: 35026217BACKGROUND
  • Cardoso 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.

    PMID: 34762812BACKGROUND

Related Links

MeSH Terms

Conditions

Voice DisordersCommunication Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Laryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurobehavioral ManifestationsNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • kelly Greyce SC Oliveira, PhD student

    UFPE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

July 9, 2024

First Posted

August 9, 2024

Study Start

March 30, 2023

Primary Completion

December 12, 2023

Study Completion

April 20, 2024

Last Updated

August 15, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations