The Dystonia Coalition Natural History and Biospecimen Repository for Isolated Dystonias (DCP)
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ClinicalTrials.gov Identifier: NCT01373424 |
Recruitment Status :
Completed
First Posted : June 15, 2011
Last Update Posted : October 26, 2020
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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 |
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 |

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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- Observational [ Time Frame: 7 years ]There is no primary outcome measure as this is an observational study.
Biospecimen Retention: Samples With DNA

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.
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 |
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

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

Principal Investigator: | H. A. Jinnah, MD, PhD | Emory University |
Documents provided by Hyder A. Jinnah, MD, PhD, Emory University:
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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Observational study Cross-sectional and Prospective study Cohort and case-control study |
Dystonia Dystonic Disorders Dyskinesias Neurologic Manifestations |
Nervous System Diseases Movement Disorders Central Nervous System Diseases |