Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Dystonia Coalition Natural History and Biospecimen Repository for Isolated Dystonias (DCP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01373424
Recruitment Status : Completed
First Posted : June 15, 2011
Last Update Posted : October 26, 2020
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Office of Rare Diseases (ORD)
Allergan
Dystonia Study Group
Information provided by (Responsible Party):
Hyder A. Jinnah, MD, PhD, Emory University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Dystonia

Detailed 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.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 3265 participants
Observational Model: Other
Time Perspective: Other
Official Title: Natural History and Biospecimen Repository for Dystonia; Comprehensive Rating Tools for Cervical Dystonia; Validity & Reliability of Diagnostic Methods & Measures of Spasmodic Dysphonia
Study Start Date : January 2011
Actual Primary Completion Date : September 30, 2020
Actual Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dystonia

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Observational [ Time Frame: 7 years ]
    There is no primary outcome measure as this is an observational study.


Biospecimen Retention:   Samples With DNA
Whole blood, DNA, white blood cells, cell lines

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01373424


Locations
Show Show 42 study locations
Sponsors and Collaborators
Emory University
National Institute of Neurological Disorders and Stroke (NINDS)
Office of Rare Diseases (ORD)
Allergan
Dystonia Study Group
Investigators
Layout table for investigator information
Principal Investigator: H. A. Jinnah, MD, PhD Emory University
  Study Documents (Full-Text)

Documents provided by Hyder A. Jinnah, MD, PhD, Emory University:
Informed Consent Form  [PDF] August 3, 2016

More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Hyder A. Jinnah, MD, PhD, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT01373424    
Other Study ID Numbers: IRB00046266
U54TR001456 ( U.S. NIH Grant/Contract )
RDCRN#6301 ( Other Identifier: Other )
U54NS065701 ( U.S. NIH Grant/Contract )
First Posted: June 15, 2011    Key Record Dates
Last Update Posted: October 26, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hyder A. Jinnah, MD, PhD, Emory University:
Observational study
Cross-sectional and Prospective study
Cohort and case-control study
Additional relevant MeSH terms:
Layout table for MeSH terms
Dystonia
Dystonic Disorders
Dyskinesias
Neurologic Manifestations
 Nervous System Diseases
Movement Disorders
Central Nervous System Diseases