跳至主要内容
临床试验/NCT04421365
NCT04421365招募中不适用

Adaptive Closed-loop Brain-computer Interface Therapeutic Intervention in Laryngeal Dystonia

Kristina Simonyan2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年4月18日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
2
主要终点
Changes in voice symptoms

研究概览

简要总结

The researchers will develop and evaluate the use of adaptive closed-loop brain-computer interface therapeutic intervention in laryngeal dystonia.

详细描述

Dystonia is a neurological disorder, which causes involuntary, sustained muscle contractions, resulting in uncontrollable twisting, repetitive movements, and abnormal postures. Selective impairment of motor control of highly skilled and goal-oriented behaviors is the defining feature of task-specific focal dystonias. Among these, laryngeal dystonia (LD) is characterized by involuntary spasms in laryngeal muscles, which selectively occur during speaking but not whispering, crying, or laughing. As speech communication is a vital part of our daily existence, LD symptoms have a deeply pervasive effect on the quality of life of the affected individual, often extending beyond speech motor deficits and causing significant occupational disability, psychiatric comorbidities, long-lasting stress, and social isolation.

Despite the chronic, debilitating impact of LD, its clinical management remains stagnant. The overall objective of this study is to conduct a randomized, sham-controlled, parallel design, phase 1 clinical trial to assess the feasibility and efficacy of a neurofeedback brain-computer interface (BCI) paradigm in LD patients that acts upon and modulates the disorder pathophysiology. The rationale for the proposed studies is that delineation of task-specific neural alterations for their feasible utilization as a pathophysiological target of therapeutic intervention will establish a robust scientific foundation for the development of novel strategies for LD treatment, inform the conduct of the next phase of the clinical trial, and directly contribute to closing the existing critical gap in the clinical management of this disorder.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, 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

结局指标

主要结局

Changes in voice symptoms

时间窗: At the end of day 5 of the intervention

Change in the number of dystonic voice breaks as the result of active neurofeedback BCI intervention assessed using perceptual voice analysis

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor 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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