Dystonia Coalition Projects

Terminated

• Conditions: Dystonia

• Registration Number: NCT04156022
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

Dystonia is a disorder characterized by excessive involuntary contraction of muscles with repetitive and patterned movements. The primary focal dystonias are the most common type of dystonia and include Limb dystonias (like writer's cramp), Cervical dystonia (spasmodic torticollis), Laryngeal dystonias (like spasmodic dysphonia), and Craniofacial dystonias (like blepharospasm). The purpose of this study is to create resources to help learn more about the primary focal dystonias and to develop and validate various dystonia rating scales.

Detailed Description

This collaborative, international effort has two primary goals. The first is to create a biospecimen repository and associated clinical database to be used as a resource for dystonia and related disease research. The second goal is to create and validate various rating scales for focal dystonias to be used during a typical clinical examination. Across sites, the investigators hope to enroll at least 5,000 adult patients.

Subjects of this study will be asked to complete a neurological exam which will be videotaped, complete some questionnaires, and donate a blood sample. A study visit will take between 45 minutes and 1 hour depending upon which portions of the study a subject completes. A subset of subjects will be asked to return no more often than once a year for a one hour follow-up visit.

Study Timeline

• Study Start: 2015-05-01
• Primary Completion: 2017-08-01
• Study Completion: 2017-08-01
• Study First Submitted: 2019-01-08
• Status Verified: 2019-11
• Study First Submitted QC: 2019-11-06
• Last Update Submitted: 2019-11-06
• Study First Posted: 2019-11-07
• Last Update Posted: 2019-11-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• Diagnosed with primary dystonia
• To be included in laryngeal dystonia group, nasolaryngoscopy (voice box exam) must have been completed to confirm diagnosis

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Exclusion Criteria

-Any person with secondary dystonia

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To collect clinical data for future studies that will help to understand the varied clinical manifestations, natural history, and pathogenesis of the dystonias.	Through study completion, an average of two years.	data collected will be demographic and medical information
To create a biospeciman repository as a resource for future research in dystonia and related diseases	Through study completion, an average of two years.
To develop and validate rating scales that can be used to diagnose different forms of dystonia and monitor their severity over time	Through study completion, an average of two years.	a six phase process will be employed to develop and evaluate a scale that is specifically designed to assess psychiatric co-morbidities in cervical dysplasia (CD)