The Dystonia Coalition Natural History and Biospecimen Repository for Isolated Dystonias

Dystonia Clinical Trial

— DCP  

Official title:

Natural History and Biospecimen Repository for Dystonia; Comprehensive Rating Tools for Cervical Dystonia; Validity & Reliability of Diagnostic Methods & Measures of Spasmodic Dysphonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01373424
• Other study ID #: IRB00046266
• Secondary ID: U54TR001456RDCRN
• Status: Completed
• Start date: January 2011
• Est. completion date: September 30, 2020

Study information

• Verified date: October 2020
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Dystonia is a disorder characterized by excessive involuntary contraction of muscles with repetitive and patterned movements. The isolated 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 isolated dystonias, myoclonus dystonia, and dopa-responsive dystonia and to develop and validate various dystonia rating scales.

Description:

This collaborative, international effort has one primary goal. This is to create a biospecimen repository and associated clinical database to be used as a resource for dystonia and related disease research. 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 video recorded, complete some questionnaires, and donate a blood sample. A study visit will take between 45 minutes and 1 hour. All subjects will be asked to return every 1, 2, 3, or 4 years for a one hour follow-up visit. People may participate in this study without agreeing to participate in the follow-up visits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3265
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with isolated dystonia or myoclonus dystonia or dopa-responsive dystonia
• To be included in laryngeal dystonia group, nasolaryngoscopy (voice box exam) must have been completed to confirm diagnosis (this voice box exam is not part of the study)

Exclusion Criteria:

• Any evidence of a secondary cause for dystonia (other than myoclonus dystonia or dopa-responsive dystonia)
• Less than 2 months since last botulinum toxin injection
• Inability to provide informed consent
• Significant medical or neurological conditions that preclude completing the neurological exam
• Significant physical or other condition that would confound diagnosis or evaluation, other than dystonia or tremor

Related Conditions & MeSH terms

• Dystonia
• Dystonic Disorders

Locations

Country	Name	City	State
Australia	Westmead Hospital	Westmead
Canada	University of Alberta	Edmonton	Alberta
Canada	Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec
Canada	Toronto Western Hospital	Toronto	Ontario
France	Hopital de la Salpetriere	Paris
Germany	University Hospital of Schleswig-Holstein	Luebeck
Italy	University of Rome	Rome
United Kingdom	University College London Institute of Neurology	London
United States	University of New Mexico	Albuquerque	New Mexico
United States	Emory University	Atlanta	Georgia
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Maryland	Baltimore	Maryland
United States	National Institutes of Health	Bethesda	Maryland
United States	University of Alabama, Birmingham	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Lahey Hospital and Medical Center	Burlington	Massachusetts
United States	Rush University	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	University of Texas, Southwestern	Dallas	Texas
United States	University of Colorado, Denver	Denver	Colorado
United States	Parkinson's and Movement Disorders Center of Maryland	Elkridge	Maryland
United States	Sanford Health - Fargo	Fargo	North Dakota
United States	Parkinson's and Movement Disorders Institute	Fountain Valley	California
United States	University of Florida, Gainesville	Gainesville	Florida
United States	James Madison University	Harrisonburg	Virginia
United States	Baylor College of Medicine	Houston	Texas
United States	Houston Methodist Neurological Institute	Houston	Texas
United States	University of Texas	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	Booth Gardner Parkinson's Care Center	Kirkland	Washington
United States	University of California, San Diego	La Jolla	California
United States	University of Tennessee	Memphis	Tennessee
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Mount Sinai Beth Israel	New York	New York
United States	Mount Sinai Medical Center	New York	New York
United States	University of Pennsylvania, Parkinson's Disease and Movement Disorders Center	Philadelphia	Pennsylvania
United States	Virginia Commonwealth University	Richmond	Virginia
United States	University of Rochester	Rochester	New York
United States	Washington University in St. Louis	Saint Louis	Missouri
United States	Mayo Clinic, Arizona	Scottsdale	Arizona
United States	Wake Forest	Winston-Salem	North Carolina

Sponsors (5)

Lead Sponsor	Collaborator
Emory University	Allergan, Dystonia Study Group, National Institute of Neurological Disorders and Stroke (NINDS), Office of Rare Diseases (ORD)

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observational	There is no primary outcome measure as this is an observational study.	7 years

External Links

•   Dystonia Coalition website