跳至主要内容
临床试验/NCT05216770
NCT05216770招募中早期 1 期

Understanding Disorder-specific Neural Pathophysiology in Laryngeal Dystonia and Voice Tremor

Massachusetts Eye and Ear Infirmary1 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2022年3月24日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
招募中
入组人数
165
试验地点
1
主要终点
Effects of sensorimotor brain modulation on voice function in laryngeal dystonia

研究概览

简要总结

The researchers will examine functional neural correlates that differentiate between laryngeal dystonia and voice tremor and contribute to disorder-specific pathophysiology using a cross-disciplinary approach of multimodal brain imaging.

详细描述

Laryngeal dysphonia (LD) and Voice Tremor (VT) are neurological voice disorders that impair speech production. The characteristic feature of LD (i.e., occurring during speaking but not laughing or crying) and the lack of physical laryngeal abnormalities suggests that LD is likely a disorder affecting the task-specific control of phonation by the central nervous system (CNS). Similarly, VT is often observed without any clear peripheral laryngeal etiology, also suggesting a central origin but distinct from that affected in LD. The overall goal of this project is to characterize the common and distinct features of CNS pathophysiology in the neurological voice disorders, LD and VT. The act of speech is a dynamic process, including initial glottal movement, voice onset, and compensatory responses to sensory feedback fluctuations during sustained phonation. Identifying specific functional impairments in LD and VT requires a clear understanding of when in the process of phonation, as well as where in the CNS, aberrant activity occurs. Due to their poor temporal resolution, prior neuroimaging studies have not been able to address the question of when abnormal CNS activation occurs relative to specific phonation events. As a result, critical clues about the underlying etiologies in these disorders have likely been missed. A multimodal brain imaging will asses CNS abnormalities associated with LD and VT, specifically 1) Spatial and temporal CNS pathophysiology during speech and other vocal tasks; 2) Sensorimotor modulations on CNS pathophysiology; and 3) Motor learning and CNS pathophysiology. Future treatments for LD and VT can be developed by targeting CNS pathophysiological mechanisms identified in this project.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Spatial and temporal CNS pathophysiology of laryngeal dystonia and voice tremor

Other

Simultaneous fMRI with EEG and MEG imaging will be used to examine neural dynamics during phonation.

干预措施: Brain imaging (Other)

Sensorimotor modulations of laryngeal dystonia and voice tremor with bupivacaine

Active Comparator

Topical laryngeal block (1 ml of 0.75% bupivacaine solution) will be used to modulate somatosensory feedback from the laryngeal mucosa during speech production and examine associated changes in brain activity.

干预措施: Laryngeal sensory block with topical bupivacaine (Drug)

Motor learning and CNS pathophysiology of laryngeal dystonia and voice tremor

Other

Implicit learning of the production of motor sequences will be examined during simultaneous fMRI/EEG and MEG imaging.

Sensorimotor adaptation of speech production during MEG imaging will be examined during perturbing pitch or formants of auditory feedback consistently during speech production and examining the behavioral and neural correlates of the resulting across-trial adaptation responses.

干预措施: Brain imaging (Other)

Auditory feedback processing in laryngeal dystonia and voice tremor

Other

The role of auditory feedback processing on task-induced speech sensorimotor activity will be examined using MEG imaging during perturbing pitch or formants of auditory feedback, unpredictably during speech production, and examining the behavioral and neural correlates of the resulting within-trial compensation responses.

干预措施: Brain imaging (Other)

结局指标

主要结局

Effects of sensorimotor brain modulation on voice function in laryngeal dystonia

时间窗: 5 years

Quantitative measures of symptoms will be determined using Burk-Fahn-Marsden Dystonia Rating Scale where higher score means a worse outcome, following sensorimotor feedback modulation in patients with laryngeal dystonia

Effects of sensorimotor brain modulation on voice function in voice tremor

时间窗: 5 years

Quantitative measures of symptoms will be determined using Fahn-Tolosa-Marin Rating Scale where higher score means a worse outcome, following sensorimotor feedback modulation in patients with voice tremor

Functional MRI, MEG and EEG signal changes in laryngeal dystonia compared to voice tremor

时间窗: 5 years

Qualitative analysis of brain regions with disorder-specific increases and decreases of spatial (functional MRI) and temporal (MEG and EEG) signals will be determined in patients with laryngeal dystonia compared to patients with voice tremor

次要结局

未报告次要终点

研究者

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

Kristina Simonyan

Professor of Otolaryngology - Head and Neck Surgery

Massachusetts Eye and Ear Infirmary

研究点 (1)

Loading locations...

相似试验