The Dystonia Coalition Natural History and Biospecimen Repository for Isolated Dystonias (DCP)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified May 2016 by Emory University
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
ClinicalTrials.gov Identifier:
NCT01373424
First received: June 2, 2011
Last updated: May 18, 2016
Last verified: May 2016
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Purpose
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 |
|---|
|
Dystonia |
| Study Type: | Observational |
| Official Title: | Natural History and Biospecimen Repository for Dystonia; Comprehensive Rating Tools for Cervical Dystonia; Validity & Reliability of Diagnostic Methods & Measures of Spasmodic Dysphonia |
Resource links provided by NLM:
Further study details as provided by Emory University:
Primary Outcome Measures:
- Observational [ Time Frame: 7 years ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 5000 |
| Study Start Date: | January 2011 |
| Estimated Primary Completion Date: | June 2017 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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
|
|
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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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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01373424
Show 40 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01373424
Contacts
| Contact: Ami R Rosen, MS, CGC | 404-727-3381 | arosen3@emory.edu |
Show 40 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 |
More Information
Additional Information:
| Responsible Party: | Hyder A. Jinnah, MD, PhD, Principal Investigator, Emory University |
| ClinicalTrials.gov Identifier: | NCT01373424 History of Changes |
| Other Study ID Numbers: | IRB00046266 U54TR001456 RDCRN#6301 U54NS065701 |
| Study First Received: | June 2, 2011 |
| Last Updated: | May 18, 2016 |
| Health Authority: | United States: Institutional Review Board Canada: Ethics Review Committee Italy: Ethics Committee France: Committee for the Protection of Personnes Germany: Ethics Commission Australia: Human Research Ethics Committee United Kingdom: National Health Service |
| Individual Participant Data | |
| 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 Emory University:
|
Observational study Cross-sectional and Prospective study Cohort and case-control study |
Additional relevant MeSH terms:
|
Dystonia Dystonic Disorders Dyskinesias Neurologic Manifestations |
Nervous System Diseases Signs and Symptoms Movement Disorders Central Nervous System Diseases |
ClinicalTrials.gov processed this record on September 26, 2016