NCT01373424

Brief 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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,265

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
7 countries

42 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 15, 2011

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

October 26, 2020

Status Verified

October 1, 2020

Enrollment Period

9.8 years

First QC Date

June 2, 2011

Last Update Submit

October 23, 2020

Conditions

Keywords

Observational studyCross-sectional and Prospective studyCohort and case-control study

Outcome Measures

Primary Outcomes (1)

  • Observational

    There is no primary outcome measure as this is an observational study.

    7 years

Study Arms (8)

Cervical dystonia

People diagnosed with cervical dystonia

Laryngeal dystonia

People diagnosed with laryngeal dystonia

Other voice disorders

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

Craniofacial dystonia

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

Limb dystonia

People diagnosed with limb dystonia

All other isolated dystonias

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

Myoclonus dystonia

People diagnosed with myoclonus dystonia

Dopa-responsive dystonia

People diagnosed with dopa-responsive dystonia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People with dystonia are eligible to participate as long as they are above age 18 and fit the eligibility criteria. The coordinator at the site you contact can tell you more about this.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (42)

University of Alabama, Birmingham

Birmingham, Alabama, 35233, United States

Location

Mayo Clinic, Arizona

Scottsdale, Arizona, 85259, United States

Location

Parkinson's and Movement Disorders Institute

Fountain Valley, California, 72708, United States

Location

University of California, San Diego

La Jolla, California, 92037, United States

Location

University of Colorado, Denver

Denver, Colorado, 80045, United States

Location

University of Florida, Gainesville

Gainesville, Florida, 32611, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Rush University

Chicago, Illinois, 60612, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

National Institutes of Health

Bethesda, Maryland, 20892, United States

Location

Parkinson's and Movement Disorders Center of Maryland

Elkridge, Maryland, 21075, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87113, United States

Location

Mount Sinai Beth Israel

New York, New York, 10003, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

University of Rochester

Rochester, New York, 14618, United States

Location

Wake Forest

Winston-Salem, North Carolina, 27157, United States

Location

Sanford Health - Fargo

Fargo, North Dakota, 58103, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

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

Philadelphia, Pennsylvania, 19107, United States

Location

University of Tennessee

Memphis, Tennessee, 38163, United States

Location

University of Texas, Southwestern

Dallas, Texas, 75390, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Houston Methodist Neurological Institute

Houston, Texas, 77030, United States

Location

University of Texas

Houston, Texas, 77030, United States

Location

James Madison University

Harrisonburg, Virginia, 22807, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Booth Gardner Parkinson's Care Center

Kirkland, Washington, 98034, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Westmead Hospital

Westmead, Australia

Location

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

Toronto Western Hospital

Toronto, Ontario, MST 258, Canada

Location

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2C 4M1, Canada

Location

Hopital de la Salpetriere

Paris, France

Location

University Hospital of Schleswig-Holstein

Lübeck, 23562, Germany

Location

University of Rome

Rome, Italy

Location

University College London Institute of Neurology

London, WC1N 3BG, United Kingdom

Location

Related Publications (1)

  • 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.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, DNA, white blood cells, cell lines

MeSH Terms

Conditions

Dystonia

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • H. A. Jinnah, MD, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 2, 2011

First Posted

June 15, 2011

Study Start

January 1, 2011

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

October 26, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will share

Data is available to researchers with appropriate ethics board approvals. Researchers may contact the Dystonia Coalition PI or coordinator at Emory University or the RDCRN Data Management and Coordination Center for more information.

Locations