Dystonia Coalition Projects (DCP)
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Purpose
Dystonia is a disorder characterized by excessive involuntary contraction of muscles with repetitive and patterned movements. The primary focal 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 primary focal dystonias and to develop and validate various dystonia rating scales.
| Condition |
|---|
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Dystonia Voice Disorders |
| 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 |
- Observational [ Time Frame: 5 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: | August 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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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
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Cranial dystonia
People diagnosed with cranial dystonia
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Oromandibular dystonia
People diagnosed with oromandibular dystonia
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Limb dystonia
People diagnosed with limb dystonia
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All other dystonias
People diagnosed with any primary dystonia not listed in descriptions of other cohorts
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Detailed Description:
This collaborative, international effort has two primary goals. The first is to create a biospecimen repository and associated clinical database to be used as a resource for dystonia and related disease research. The second goal is to create and validate various rating scales for focal dystonias to be used during a typical clinical examination. 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 videotaped, complete some questionnaires, and donate a blood sample. Subjects with laryngeal dystonia and voice disorders will also be asked to have a transnasal laryngoscopy (an exam of the voice box) where the subject has a flexible tube passed through their nose and into the throat to view the throat and voice box. A study visit will take between 45 minutes and 4 hours depending upon which portions of the study a subject completes. A subset of subjects will be asked to return annually for a one hour visit.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
People with dystonia and voice disorders are eligible to participate as long as they are above age 18 and fit the eligibility criteria. To participate in some parts of the study, you must be under the age of 80. The coordinator at the site you contact can tell you more about this.
Inclusion Criteria:
- Diagnosed with primary dystonia OR
- Diagnosed with voice disorders like muscle tension dysphonia, psychogenic dysphonia, and vocal fold paresis or paralysis
- To be included in laryngeal dystonia or voice disorder groups, nasolaryngoscopy (voice box exam) must have been completed to confirm diagnosis
Exclusion Criteria:
- Any evidence of a secondary cause for dystonia
- Less than 2 months since last botulinum toxin injection
Criteria that will keep people from participating in some research activities:
- Any surgical treatment for dystonia
- Significant medical or neurological conditions that preclude completing the neurological exam
- For those with voice disorders and laryngeal dystonia, significant medical or neurological conditions that preclude completing a nasolaryngoscopy
- Significant physical or other condition that would confound diagnosis or evaluation, other than dystonia or tremor
- Being on varying doses of certain medications within the past one month
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01373424
| Contact: Ami R Rosen, MS, CGC | 404-727-3381 | arosen3@emory.edu |
Show 41 Study Locations
| Principal Investigator: | H. A. Jinnah, MD, PhD | Emory University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Hyder A. Jinnah, MD, PhD, Principal Investigator, Emory University |
| ClinicalTrials.gov Identifier: | NCT01373424 History of Changes |
| Other Study ID Numbers: | IRB00046266, 1U54NS065701, RDCRN#6301 |
| Study First Received: | June 2, 2011 |
| Last Updated: | December 9, 2014 |
| Health Authority: | United States: Institutional Review Board Canada: Ethics Review Committee |
Keywords provided by Emory University:
|
Observational study Cross-sectional and Prospective study Cohort and case-control study |
Additional relevant MeSH terms:
|
Dystonia Dystonic Disorders Central Nervous System Diseases Dyskinesias |
Movement Disorders Nervous System Diseases Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on March 03, 2015