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临床试验/NCT06612528
NCT06612528已完成不适用

Effect of Transcranial Direct Current Stimulation on Singers' Voice

Universidade Federal de Pernambuco2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年3月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
2
主要终点
Vocal Range Profile

研究概览

简要总结

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 were randomized to one of the three tDCS groups (primary motor cortex, cerebellum or sham). In each group a voice training was 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 passed for 10 intervention days and they were 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 was taken 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, CPPS,HNR, and dysphonia acoustic index) at weak, habitual, and strong intensities; laryngeal diadochokinesis, and self-reported vocal effort using the adapted Borg CR10 scale.

详细描述

Data collection was conducted at the Applied Neuroscience Laboratory (LANA) of the Federal University of Pernambuco (UFPE).

This 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, a pilot study was conducted with 15 participants using the G*Power 3.1 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) was considered, and the sample size considered was 45, the largest value among the selected outcomes.

Singers without formal music training and without vocal complaints were included.

Individuals who were smokers or who presented signs and symptoms of laryngeal, pharyngeal or respiratory diseases at the time of data collection were excluded from the sample. Volunteers who were using neuroactive medications regularly, have metal implants in the cervical region or above, and had any history of seizures or epilepsy were also excluded.

The sample of singers was constituted by convenience through individuals who were singers without vocal complaints of both sexes, recruited through advertisements in electronic media. The first contact with the volunteers was through a screening to verify the eligibility criteria.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Vocally healthy singers without formal singing education

排除标准

  • Abnormalities in previous screening for voice symptoms
  • Exhibited signs and symptoms of laryngeal, pharyngeal, or respiratory diseases at the time of collection
  • Used neuroactive medications
  • Had metallic implants in the cervical region or above
  • Had any history of seizures or epilepsy

研究组 & 干预措施

M1 and vocal exercise

Experimental

anodal tDCS over primary motor cortex associated with the vocal exercise using the flexible tube in water.

干预措施: tDCS (Device)

M1 and vocal exercise

Experimental

anodal tDCS over primary motor cortex associated with the vocal exercise using the flexible tube in water.

干预措施: Flexible tube in water (Device)

Cerebellum and vocal exercise

Active Comparator

anodal tDCS over cerebellum associated with the vocal exercise using the flexible tube in water.

干预措施: tDCS (Device)

Cerebellum and vocal exercise

Active Comparator

anodal tDCS over cerebellum associated with the vocal exercise using the flexible tube in water.

干预措施: Flexible tube in water (Device)

Sham and vocal exercise

Placebo Comparator

tDCS sham associated with the vocal exercise using the flexible tube in water.

干预措施: tDCS (Device)

Sham and vocal exercise

Placebo Comparator

tDCS sham associated with the vocal exercise using the flexible tube in water.

干预措施: Flexible tube in water (Device)

结局指标

主要结局

Vocal Range Profile

时间窗: From enrollment to the end of evaluation at 6 weeks

Minimum fundamental frequency - f0; Maximum f0; Extension f0; Extension in Semitone; Minimum intensity; Maximum intensity and Area

次要结局

  • Vocal quality(From enrollment to the end of evaluation at 6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kátia Monte-Silva

Principal investigator

Universidade Federal de Pernambuco

研究点 (2)

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