The Dystonia Coalition Natural History and Biospecimen Repository for Isolated Dystonias

NCT ID: NCT01373424

Last Updated: 2020-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3265 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2020-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dystonia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Cervical dystonia

People diagnosed with cervical dystonia

No interventions assigned to this group

Laryngeal dystonia

People diagnosed with laryngeal dystonia

No interventions assigned to this group

Other voice disorders

People diagnosed with a voice disorder other than laryngeal dystonia - enrollment for this group is complete

No interventions assigned to this group

Craniofacial dystonia

People diagnosed with craniofacial dystonia (including blepharospasm, meige syndrome, and oromandibular dystonia)

No interventions assigned to this group

Limb dystonia

People diagnosed with limb dystonia

No interventions assigned to this group

All other isolated dystonias

People diagnosed with any isolated dystonia not listed in descriptions of other cohorts

No interventions assigned to this group

Myoclonus dystonia

People diagnosed with myoclonus dystonia

No interventions assigned to this group

Dopa-responsive dystonia

People diagnosed with dopa-responsive dystonia

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Office of Rare Diseases (ORD)

NIH

Sponsor Role collaborator

Allergan

INDUSTRY

Sponsor Role collaborator

Dystonia Study Group

OTHER

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Hyder A. Jinnah, MD, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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H. A. Jinnah, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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University of Alabama, Birmingham

Birmingham, Alabama, United States

Site Status

Mayo Clinic, Arizona

Scottsdale, Arizona, United States

Site Status

Parkinson's and Movement Disorders Institute

Fountain Valley, California, United States

Site Status

University of California, San Diego

La Jolla, California, United States

Site Status

University of Colorado, Denver

Denver, Colorado, United States

Site Status

University of Florida, Gainesville

Gainesville, Florida, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Rush University

Chicago, Illinois, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

University of Iowa

Iowa City, Iowa, United States

Site Status

University of Maryland

Baltimore, Maryland, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

National Institutes of Health

Bethesda, Maryland, United States

Site Status

Parkinson's and Movement Disorders Center of Maryland

Elkridge, Maryland, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

Site Status

Washington University in St. Louis

St Louis, Missouri, United States

Site Status

University of New Mexico

Albuquerque, New Mexico, United States

Site Status

Mount Sinai Beth Israel

New York, New York, United States

Site Status

Mount Sinai Medical Center

New York, New York, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

Wake Forest

Winston-Salem, North Carolina, United States

Site Status

Sanford Health - Fargo

Fargo, North Dakota, United States

Site Status

University of Cincinnati

Cincinnati, Ohio, United States

Site Status

University of Pennsylvania, Parkinson's Disease and Movement Disorders Center

Philadelphia, Pennsylvania, United States

Site Status

University of Tennessee

Memphis, Tennessee, United States

Site Status

University of Texas, Southwestern

Dallas, Texas, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

Houston Methodist Neurological Institute

Houston, Texas, United States

Site Status

University of Texas

Houston, Texas, United States

Site Status

James Madison University

Harrisonburg, Virginia, United States

Site Status

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Booth Gardner Parkinson's Care Center

Kirkland, Washington, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Westmead Hospital

Westmead, , Australia

Site Status

University of Alberta

Edmonton, Alberta, Canada

Site Status

Toronto Western Hospital

Toronto, Ontario, Canada

Site Status

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

Site Status

Hopital de la Salpetriere

Paris, , France

Site Status

University Hospital of Schleswig-Holstein

Lübeck, , Germany

Site Status

University of Rome

Rome, , Italy

Site Status

University College London Institute of Neurology

London, , United Kingdom

Site Status

Countries

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United States Australia Canada France Germany Italy United Kingdom

References

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Patel N, Hanfelt J, Marsh L, Jankovic J; members of the Dystonia Coalition. Alleviating manoeuvres (sensory tricks) in cervical dystonia. J Neurol Neurosurg Psychiatry. 2014 Aug;85(8):882-4. doi: 10.1136/jnnp-2013-307316. Epub 2014 May 14.

Reference Type DERIVED
PMID: 24828895 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Related Links

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http://rdcrn.org/Dystonia

Dystonia Coalition website

Other Identifiers

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U54TR001456

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RDCRN#6301

Identifier Type: OTHER

Identifier Source: secondary_id

U54NS065701

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00046266

Identifier Type: -

Identifier Source: org_study_id