An interventional study of Transcranial direct current stimulation in Voice and Resonance Disorders, Transcranial Direct Current Stimulation and Voice Disturbance, sponsored by Universidade Federal de Pernambuco. Completed at 1 site in Brazil. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-15.
Sponsored by Universidade Federal de Pernambuco · Not applicable, Interventional, and Treatment
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).
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%
77 studies on the registry are indexed under Voice Disorders; 17 are open to participants now.
This study's enrollment of 16 is below the median of 41 across 54 interventional studies indexed under Voice Disorders.
Browse Voice Disorders studies →Universidade Federal de Pernambuco is the lead sponsor of 166 studies on the registry; 22 are open to participants now.
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The aim of this arm is to verify the effect on the voice of anodal tDCS M1 larynx target.
Device: Transcranial direct current stimulation
The aim of this arm is to verify the effect on the voice of anodal tDCS S1 larynx target.
Device: Transcranial direct current stimulation
The aim of this arm is to verify the effect on the voice of anodal tDCS PFDLC target.
Device: Transcranial direct current stimulation
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.
Also known as: tDCS, transcranial electrical stimulation, anodal stimulation tDCS
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 (%)
Time frame: through study completion, an average of 6 months
Voice
Jitter (%); Shimmer (%); Irregularity; GNE; DAI
Time frame: 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
Time frame: 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).
Time frame: through study completion, an average of 6 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2023 to primary completion in Dec 2023, 8 months.
Of 30 interventional studies with no phase under Voice Disorders, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 48. This study's 8 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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