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Clinical Trials/NCT04421365
NCT04421365
Recruiting
Not Applicable

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

Kristina Simonyan1 site in 1 country40 target enrollmentApril 18, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Laryngeal Dystonia
Sponsor
Kristina Simonyan
Enrollment
40
Locations
1
Primary Endpoint
Changes in voice symptoms
Status
Recruiting
Last Updated
5 months ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
April 18, 2022
End Date
August 31, 2027
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Kristina Simonyan

Professor of Otolaryngology - Head and Neck Surgery

Massachusetts Eye and Ear Infirmary

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Changes in voice symptoms

Time Frame: 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

Study Sites (1)

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