跳至主要内容
临床试验/NCT05150093
NCT05150093招募中不适用

Deep Brain Stimulation in Laryngeal Dystonia and Voice Tremor

Massachusetts Eye and Ear Infirmary2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年6月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
2
主要终点
Correlations between brain signals and intraoperative voice and speech production performance.

研究概览

简要总结

The goals of this project are 1) to determine the incidence of neurological voice disorders in patients with dystonia and essential tremor undergoing deep brain stimulation (DBS), 2) investigate the neuroimaging and intracranial neurophysiology correlates of voice dysfunction in these subjects, and subsequently 3) determine the effects of DBS on voice function.

详细描述

Loss of voice control, which is critical for conveying effective spoken communication, is often a significant feature in patients with movement disorders, such as dystonia and essential tremor. Voice dysfunction, however, has been overshadowed clinically by a focus on limb motor symptoms. For example, deep brain stimulation (DBS) effectively reduces limb dystonia and tremor in these patients, but the modulation of voice symptoms by DBS has been vastly understudied. It is assumed that the production and modulation of voice are regulated by the basal ganglia-thalamo-cortical network in a loop architecture that is common to all motor behaviors. There is, however, little empirical data to inform our specific understanding of how voice function is encoded in basal ganglia-thalamo-cortical interactions. The overall goal of this research is to use a combination of invasive and non-invasive human neuroscience to improve our understanding of the incidence and neural correlates of neurological voice disorders (laryngeal dystonia and voice tremor) in patients with isolated dystonia and essential tremor undergoing DBS surgery. The investigators will use simultaneous electrocorticography (ECoG) and subcortical activity recording in dystonia and tremor patients who are awake and speaking during DBS implantation surgery. The results of this research will inform the development of strategies for closed-loop brain stimulation specifically to treat neurological voice dysfunction that can be tested in a subsequent clinical trial.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

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
否

入选标准

  • •Clinical indications to proceed with DBS implantation, as determined by the clinical multidisciplinary movement disorders board, including: a) definitive diagnosis of essential tremor or dystonia, b) medically refractory disease, c) adequate performance on neuropsychological evaluation as determined by a licensed clinical neuropsychologist.
  • •The ability to comply with test directions, complete pre-operative task training, and provide informed consent.
  • •Age 18-80 years.
  • •1. Inability to understand or perform the task outlined in the protocol during a pre-surgery training session.
  • •Significant hearing loss.
  • •3. Cortical venous anatomy that could potentially obstruct ECoG electrode placement, as determined by the surgeon, visualized on pre-op MRI or during surgery.

排除标准

  • 未提供

研究组 & 干预措施

Electrophysiological signal data collection

Experimental

Patients diagnosed with dystonia or tremor who are recommended for DBS surgery. Electrophysiological data will be collected at the time of DBS surgery.

干预措施: Deep Brain Stimulation (Procedure)

结局指标

主要结局

Correlations between brain signals and intraoperative voice and speech production performance.

时间窗: 5 years

Analysis of intraoperative recordings from deep basal ganglia structures and cortical regions relevant to voice and speech control.

Changes in standard clinical outcome for dystonia patients

时间窗: 5 years

Quantitative measures of voice and motor changes following deep brain stimulation surgery using standard clinical criterion of Burk-Fahn-Marsden Dystonia Rating Scale where higher score means a worse outcome.

Changes in standard clinical outcome for tremor patients

时间窗: 5 years

Quantitative measures of voice and motor changes following deep brain stimulation surgery using standard clinical criterion of Fahn-Tolosa-Marin Tremor Rating Scale where higher score means a worse outcome.

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 (2)

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