The Dystonia Coalition Natural History and Biospecimen Repository for Isolated Dystonias (DCP)
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| ClinicalTrials.gov Identifier: NCT01373424 |
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Recruitment Status :
Recruiting
First Posted : June 15, 2011
Last Update Posted : August 2, 2017
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Sponsor:
Hyder A. Jinnah, MD, PhD
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
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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 |
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| Dystonia |
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 Type : | Observational |
| Estimated Enrollment : | 5000 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 |
| Estimated Primary Completion Date : | June 2018 |
| Estimated Study Completion Date : | August 2019 |
| Group/Cohort |
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Cervical dystonia
People diagnosed with cervical dystonia
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Laryngeal dystonia
People diagnosed with laryngeal dystonia
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Other voice disorders
People diagnosed with a voice disorder other than laryngeal dystonia - enrollment for this group is complete
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Craniofacial dystonia
People diagnosed with craniofacial dystonia (including blepharospasm, meige syndrome, and oromandibular dystonia)
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Limb dystonia
People diagnosed with limb dystonia
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All other isolated dystonias
People diagnosed with any isolated dystonia not listed in descriptions of other cohorts
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Myoclonus dystonia
People diagnosed with myoclonus dystonia
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Dopa-responsive dystonia
People diagnosed with dopa-responsive dystonia
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Primary Outcome Measures :
- 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
Information from the National Library of Medicine
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| 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
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
Contacts
| Contact: Adam Kassem | 404-727-3381 | akassem@emory.edu |
Show 42 Study Locations
Sponsors and Collaborators
Hyder A. Jinnah, MD, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Office of Rare Diseases (ORD)
Allergan
Dystonia Study Group
Investigators
| Principal Investigator: | H. A. Jinnah, MD, PhD | Emory University |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Hyder A. Jinnah, MD, PhD, Principal Investigator, Emory University |
| ClinicalTrials.gov Identifier: | NCT01373424 History of Changes |
| 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: | August 2, 2017 |
| Last Verified: | August 2017 |
| 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. |
Keywords provided by Hyder A. Jinnah, MD, PhD, Emory University:
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Observational study Cross-sectional and Prospective study Cohort and case-control study |
Additional relevant MeSH terms:
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Dystonia Dystonic Disorders Dyskinesias Neurologic Manifestations |
Nervous System Diseases Signs and Symptoms Movement Disorders Central Nervous System Diseases |