Early UVFP Management Based on Neurological Evidences (UVFP = Unilateral Vocal Fold Paralysis) (ION-UVFP) - Preliminary Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Central auditory processes
研究概览
简要总结
The purpose of this preliminary study is to help clarify our hypotheses for the longitudinal study by investigating the relationship between vocal cord paralysis and central auditory processes and thus the interpretation of auditory inputs into the central nervous system.
详细描述
A very recent study (Naunheim et al., 2018) shows that paralysis of a vocal cord can affect central auditory processes, which in turn would have a negative impact on motor control capabilities during voice production. This study was conducted in patients who had undergone Type I thyroplasty. To highlight these influences, the authors relied on behavioral tests of auditory perception and vocal production.
The investigators would like in this study, based on a similar and existing population at the Cliniques Universitaires Saint-Luc, to try to understand the changes observed clinically by proposing to perform vocal production tasks (also planned for the longitudinal study) in the MRI. The investigators would like to objectify the differences in the areas involved in the central auditory processes in comparison between patients and control subjects.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Unilateral paralysis in abduction of the vocal cords may be included in the study.
- •Patients who undergone type I thyroplasty (with Montgomery implant) at least 3 months ago
- •Control participants without voice disorder
排除标准
- •Wear a pacemaker or other implanted devices (prostheses ...).
- •Wear metal clips, metal in the head, or an adjustable brain drain.
- •Wear non-removable dental appliances (except fillings).
- •Wear cardiac valve prostheses.
- •Have worked the metals.
- •Have a tattoo containing metal particles.
- •Have implanted jewelry (e.g., piercing).
- •Being prone to epileptic seizures.
- •Take medications that alter cortical excitability.
- •Have had a brain surgery.
- •Suffer from intracranial hypertension.
- •Be pregnant or breastfeeding recently.
- •Present allergies that are incompatible with the experimental protocol.
- •Have an abnormal hearing loss in view of their age, identified with tonal and / or vocal audiometry.
结局指标
主要结局
Central auditory processes
时间窗: Min 3 months post thyroplasty
Auditory perception tasks performed using an audio headset (sound detection in noise, localization of a sound source, dichotic listening test, masking test, duration and frequency pattern test)
Voice quality
时间窗: Min 3 months post thyroplasty
Multidimensional voice assessment (Anamnestic interview, Maximum Phonation Time, Mean Air Flow, Mean subglottic pressure, Jitter, Shimmer, Noise-to-harmonic ratio, phonetogram, smoothed cepstral peak prominence, Voice Handicap Index - VHI-30, SF-36, EAT-10, GRBAS-I, Acoustic Voice Quality Index, Dysphonia Severity Index, Tonal and vocal audiometries)
Changes in the neuronal pathways involved in the processing of the auditory inputs
时间窗: Max 6 months after involvement in the study
Functional magnetic resonance imaging examination (tomodensitometry and connectivity)
次要结局
未报告次要终点