Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06612528
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-09-21
Brief Title:
Transcranial Direct Current Stimulation on Singer39s Voice
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Transcranial Direct Current Stimulation on Singers39 Voice
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Transcranial direct current stimulation tDCS can be used to temporarily and reversibly modulate brain functions and is an increasingly utilized tool to investigate the relationships between brain and behavior This study aimed to identify the effects of tDCS on vocal quality vocal range neuromotor functioning of the larynx and self-reported vocal effort in vocally healthy singers This is a triple-blinded sham-controlled randomized clinical trial The participants will be randomized to one of the three tDCS groups primary motor cortex cerebellum or sham In each group a voice training will be applied at the same tDCS time The three groups are i cerebellum ii primary motor cortex M1 iii sham The tDCS parameters in the active groups are anodal - 2mA for 20 minutes at the sham group the stimuli are finished 30 secondes before starting Volunteers will pass for 10 intervention days and they will be evaluated for vocal performance before the sessions in the day 5 of intervention the last day of intervention day 10 and 1 month later for follow up evaluation Voice recordings will be take to assess the following vocal parameters vocal range profile VRP at weak and strong intensities vocal quality jitter shimmer irregularity glottal-to-noise excitation ratio and dysphonia acoustic index at weak habitual and strong intensities laryngeal diadochokinesis and self-reported vocal effort using the adapted Borg CR10 scale
Detailed Description:
Data collection is being conducted at the Applied Neuroscience Laboratory LANA of the Federal University of Pernambuco UFPE Videolaryngoscopy is performed at the UFPE Hospital in the laryngology outpatient clinic
This phase of the study includes vocally healthy individuals who are singers without formal music or singing training Residents of the city of Recife and the Metropolitan Region aged 18 to 45 years The age range was chosen considering the period of maximum vocal efficiency To determine the sample size in phase 2 a pilot study was conducted with 15 participants that will serve as a parameter for sample size calculation This will be done using the GPower 31 program considering a statistical power β of 80 and a significance level α of 5 For this analysis the primary vocal outcome variables vocal range profile will be considered and the sample size will be considered the largest value among the selected outcomes
Singers without formal music training and without vocal complaints are included In order to assess vocal health all singers underwent videolaryngoscopy performed by an otolaryngologist After the exam subjects are selected who according to the otolaryngologist39s report presented functional anatomical and physiological conditions Individuals with minimal structural alterations MSA will not be excluded as long as the glottal closure is complete and with regular glottal vibration on stroboscopy
Individuals who are smokers or who present signs and symptoms of laryngeal pharyngeal or respiratory diseases at the time of data collection are excluded from the sample Volunteers who use neuroactive medications regularly have metal implants in the cervical region or above and have any history of seizures or epilepsy will also be excluded
The sample of singers is being constituted by convenience through individuals who are singers without vocal complaints of both sexes recruited through advertisements in electronic media The first contact with the volunteers is through a screening to verify the eligibility criteria
The same data collection instruments from phase 1 are used in phase 2 of this study Added to this is the vocal exercise performed with the aid of a silicone tube with the following dimensions 35cm in length 1cm in diameter and 2mm in thickness and with the distal end immersed at a distance of 3cm from the bottom of a 500ml plastic bottle containing 23 of water and with the spaces delimited This study seeks to investigate the combined effects of tDCS and vocal exercises on singers39 voices We will conduct a clinical trial to examine the impact of concurrent neuromodulation and vocal training Anodal tDCS will be applied at 2mA for 20 minutes to three groups i M1 ii Cerebellum and iii sham All groups will also perform vocal exercises using a flexible tube FT for a total of 12 minutes Participants will complete an adverse effects questionnaire after each session to report any discomfort Vocal assessment is performed before the intervention to obtain results on vocal parameters vocal range profile and vocal effort as well as on the 5th day after the start of the intervention on the 10th day and 1 month after the end of the activities The entire assessment procedure is being performed as described in phase 1 of this study only the request for the vocal task to assess perceived effort is different in the phase 2 singers In this case the participants answered the same Borg CR 10-BR scale questionnaire - adapted for vocal effort to assess the singers39 self-perception of the proposed tasks however the singers are instructed to report the intensity of the effort produced during the singing task of a song of their choice according to their self-perceived difficulty
In order to determine the volunteers who would be in each group and for subsequent sample size calculation a randomization was performed for 15 volunteers by an external researcher using a random table and adjusted to allow for counterbalancing Codes were assigned to the groups which were kept in opaque and numbered envelopes available only to the person responsible for applying the tDCS In this way the evaluator the therapist responsible for the vocal technique with a flexible tube immersed in water and the singer remain 34blind34 to the type of stimulation to which the participants are subjected After performing the sample size calculation a new randomization will be performed to allocate the participants who will continue in the data collection to complete the number of necessary volunteers
The participants are allocated into three groups namely i M1 ii Cerebellum ii sham In all groups 10 consecutive sessions of anodal tDCS associated with vocal exercise are performed these only do not occur on weekends For the application of tDCS in the groups i M1 the stimulation electrode anode is positioned over C5 international 10-20 EEG system with the cathode negative pole positioned over the contralateral supraorbital region ii Cerebellum the stimulation electrode over the cerebellar cortex inion slightly to the right and the reference electrode cathode is positioned over the right deltoid muscle ii sham the montage equivalent to cerebellar stimulation is performed however in the sham stimulation there is an interruption of the stimulation 30 seconds after the start thus the current intensity drops to zero mA but the electrodes remained on the scalp of the volunteers until the end of the vocal exercise The exercise with FT is performed for a total of 20 minutes 3 minutes of FT four sequences followed by 2 minutes of interval in all groups In the sham group the electrodes are only removed after the end of the vocal exercises so that the patient is unaware of the type of stimulation real or sham to which they were exposed To blind the evaluator and therapist a towel is placed over the volunteer39s head every day Participants were instructed to sit comfortably while electrodes were placed on their scalp and tDCS stimulation was initiated Following stimulation participants performed vocal exercises using a flexible tube The exercise involved producing sustained u vowels in ascending and descending scales tailored to each participant39s vocal range soprano mezzo-soprano contralto tenor baritone or bass These scales were based on pre-recorded piano accompaniments
The flexible tube was 35 cm long 1 cm in diameter and 2 mm thick One end of the tube was submerged 3 cm into a 500 ml bottle filled with water Participants produced four sets of vocal exercises each lasting 3 minutes with 2-minute rests between sets totaling 20 minutes of vocal therapy This ensured that the vocal exercises concluded simultaneously with the tDCS session Voice recordings will be take to assess the following vocal parameters vocal range profile VRP at weak and strong intensities vocal quality jitter shimmer irregularity glottal-to-noise excitation ratio and dysphonia acoustic index at weak habitual and strong intensities laryngeal diadochokinesis and self-reported vocal effort using the adapted Borg CR10 scale This research was conducted in accordance with the ethical guidelines established by Brazil39s National Health Council Resolution 46612 The study was approved by the Human Research Ethics Committee of UFPE39s Health Sciences Center number 5758856 Participants provided written informed consent after being fully informed about the study39s objectives procedures potential risks and benefits
While the study posed minimal risks participants might experience mild side effects from tDCS such as tingling itching or burning sensations at the electrode sites These side effects were carefully monitored Additionally some participants might experience discomfort during videolaryngoscopy or vocal exercises However these issues were addressed promptly
Participants benefited from receiving guidance on vocal health and a personalized flexible tube Data collected from vocal assessment software will be stored securely for at least 5 years All data collected using Vocalgrama and VoxMetria software were analyzed using the respective software In Vocalgrama the following outcome measures were extracted minimum and maximum fundamental frequency f0 f0 range st range minimum and maximum intensity and area of the vocal range profile In VoxMetria the following measures were extracted jitter shimmer noise-to-harmonic ratio NHR and average perturbation quotient APQ from a 6-second sustained ε vowel excluding the first and last seconds Audio recordings were made at a sampling rate of 44 kHz and 16-bit resolution VoxMetria was also used to count the number of peaks in diadochokinetic tasks Perceived effort was assessed using the Borg CR 10-BR scale adapted for vocal effort
Data normality will be assessed using the Shapiro-Wilk test The ANOVA repeated mensures will be applied between the times of evaluation All analyses will be performed using SPSS version 260 SPSS Inc Chicago USA with a significance level of 5
This phase of the study includes vocally healthy individuals who are singers without formal music or singing training Residents of the city of Recife and the Metropolitan Region aged 18 to 45 years The age range was chosen considering the period of maximum vocal efficiency To determine the sample size in phase 2 a pilot study was conducted with 15 participants that will serve as a parameter for sample size calculation This will be done using the GPower 31 program considering a statistical power β of 80 and a significance level α of 5 For this analysis the primary vocal outcome variables vocal range profile will be considered and the sample size will be considered the largest value among the selected outcomes
Singers without formal music training and without vocal complaints are included In order to assess vocal health all singers underwent videolaryngoscopy performed by an otolaryngologist After the exam subjects are selected who according to the otolaryngologist39s report presented functional anatomical and physiological conditions Individuals with minimal structural alterations MSA will not be excluded as long as the glottal closure is complete and with regular glottal vibration on stroboscopy
Individuals who are smokers or who present signs and symptoms of laryngeal pharyngeal or respiratory diseases at the time of data collection are excluded from the sample Volunteers who use neuroactive medications regularly have metal implants in the cervical region or above and have any history of seizures or epilepsy will also be excluded
The sample of singers is being constituted by convenience through individuals who are singers without vocal complaints of both sexes recruited through advertisements in electronic media The first contact with the volunteers is through a screening to verify the eligibility criteria
The same data collection instruments from phase 1 are used in phase 2 of this study Added to this is the vocal exercise performed with the aid of a silicone tube with the following dimensions 35cm in length 1cm in diameter and 2mm in thickness and with the distal end immersed at a distance of 3cm from the bottom of a 500ml plastic bottle containing 23 of water and with the spaces delimited This study seeks to investigate the combined effects of tDCS and vocal exercises on singers39 voices We will conduct a clinical trial to examine the impact of concurrent neuromodulation and vocal training Anodal tDCS will be applied at 2mA for 20 minutes to three groups i M1 ii Cerebellum and iii sham All groups will also perform vocal exercises using a flexible tube FT for a total of 12 minutes Participants will complete an adverse effects questionnaire after each session to report any discomfort Vocal assessment is performed before the intervention to obtain results on vocal parameters vocal range profile and vocal effort as well as on the 5th day after the start of the intervention on the 10th day and 1 month after the end of the activities The entire assessment procedure is being performed as described in phase 1 of this study only the request for the vocal task to assess perceived effort is different in the phase 2 singers In this case the participants answered the same Borg CR 10-BR scale questionnaire - adapted for vocal effort to assess the singers39 self-perception of the proposed tasks however the singers are instructed to report the intensity of the effort produced during the singing task of a song of their choice according to their self-perceived difficulty
In order to determine the volunteers who would be in each group and for subsequent sample size calculation a randomization was performed for 15 volunteers by an external researcher using a random table and adjusted to allow for counterbalancing Codes were assigned to the groups which were kept in opaque and numbered envelopes available only to the person responsible for applying the tDCS In this way the evaluator the therapist responsible for the vocal technique with a flexible tube immersed in water and the singer remain 34blind34 to the type of stimulation to which the participants are subjected After performing the sample size calculation a new randomization will be performed to allocate the participants who will continue in the data collection to complete the number of necessary volunteers
The participants are allocated into three groups namely i M1 ii Cerebellum ii sham In all groups 10 consecutive sessions of anodal tDCS associated with vocal exercise are performed these only do not occur on weekends For the application of tDCS in the groups i M1 the stimulation electrode anode is positioned over C5 international 10-20 EEG system with the cathode negative pole positioned over the contralateral supraorbital region ii Cerebellum the stimulation electrode over the cerebellar cortex inion slightly to the right and the reference electrode cathode is positioned over the right deltoid muscle ii sham the montage equivalent to cerebellar stimulation is performed however in the sham stimulation there is an interruption of the stimulation 30 seconds after the start thus the current intensity drops to zero mA but the electrodes remained on the scalp of the volunteers until the end of the vocal exercise The exercise with FT is performed for a total of 20 minutes 3 minutes of FT four sequences followed by 2 minutes of interval in all groups In the sham group the electrodes are only removed after the end of the vocal exercises so that the patient is unaware of the type of stimulation real or sham to which they were exposed To blind the evaluator and therapist a towel is placed over the volunteer39s head every day Participants were instructed to sit comfortably while electrodes were placed on their scalp and tDCS stimulation was initiated Following stimulation participants performed vocal exercises using a flexible tube The exercise involved producing sustained u vowels in ascending and descending scales tailored to each participant39s vocal range soprano mezzo-soprano contralto tenor baritone or bass These scales were based on pre-recorded piano accompaniments
The flexible tube was 35 cm long 1 cm in diameter and 2 mm thick One end of the tube was submerged 3 cm into a 500 ml bottle filled with water Participants produced four sets of vocal exercises each lasting 3 minutes with 2-minute rests between sets totaling 20 minutes of vocal therapy This ensured that the vocal exercises concluded simultaneously with the tDCS session Voice recordings will be take to assess the following vocal parameters vocal range profile VRP at weak and strong intensities vocal quality jitter shimmer irregularity glottal-to-noise excitation ratio and dysphonia acoustic index at weak habitual and strong intensities laryngeal diadochokinesis and self-reported vocal effort using the adapted Borg CR10 scale This research was conducted in accordance with the ethical guidelines established by Brazil39s National Health Council Resolution 46612 The study was approved by the Human Research Ethics Committee of UFPE39s Health Sciences Center number 5758856 Participants provided written informed consent after being fully informed about the study39s objectives procedures potential risks and benefits
While the study posed minimal risks participants might experience mild side effects from tDCS such as tingling itching or burning sensations at the electrode sites These side effects were carefully monitored Additionally some participants might experience discomfort during videolaryngoscopy or vocal exercises However these issues were addressed promptly
Participants benefited from receiving guidance on vocal health and a personalized flexible tube Data collected from vocal assessment software will be stored securely for at least 5 years All data collected using Vocalgrama and VoxMetria software were analyzed using the respective software In Vocalgrama the following outcome measures were extracted minimum and maximum fundamental frequency f0 f0 range st range minimum and maximum intensity and area of the vocal range profile In VoxMetria the following measures were extracted jitter shimmer noise-to-harmonic ratio NHR and average perturbation quotient APQ from a 6-second sustained ε vowel excluding the first and last seconds Audio recordings were made at a sampling rate of 44 kHz and 16-bit resolution VoxMetria was also used to count the number of peaks in diadochokinetic tasks Perceived effort was assessed using the Borg CR 10-BR scale adapted for vocal effort
Data normality will be assessed using the Shapiro-Wilk test The ANOVA repeated mensures will be applied between the times of evaluation All analyses will be performed using SPSS version 260 SPSS Inc Chicago USA with a significance level of 5
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None