Dystonia Coalition Projects (DCP)
This study is currently recruiting participants.
Verified May 2013 by Emory University
Sponsor:
Hyder A. Jinnah, MD, PhD
Collaborators:
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 6, 2013
Last verified: May 2013
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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 |
|---|
|
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 |
Resource links provided by NLM:
Further study details as provided by Emory University:
Biospecimen Retention: Samples With DNA
Detailed Description:
Whole blood, DNA, white blood cells, cell lines
| Estimated Enrollment: | 5000 |
| Study Start Date: | January 2011 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Cervical dystonia
People diagnosed with cervical dystonia
|
|
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
|
|
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
|
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 |
Study Population
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.
Criteria
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 Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01373424
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Contacts
| Contact: Ami R Rosen, MS, CGC | 404-727-3381 | arosen3@emory.edu |
Hide Study LocationsLocations
| United States, Alabama | |
| University of Alabama, Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35233 | |
| Contact: Rachel Clark, RN 205-996-2647 rclarkrn@uab.edu | |
| Principal Investigator: Natividad Stover, MD | |
| Sub-Investigator: David Standaert, MD, PhD | |
| United States, Arizona | |
| Mayo Clinic, Arizona | Recruiting |
| Scottsdale, Arizona, United States, 85259 | |
| Contact: Amy Duffy 480-301-4750 Duffy.Amy@mayo.edu | |
| Principal Investigator: Charles Adler, MD, PhD | |
| United States, California | |
| Parkinson's and Movement Disorders Institute | Not yet recruiting |
| Fountain Valley, California, United States, 72708 | |
| Contact: Philip Tran 714-378-5076 ptran@pdmi.org | |
| Principal Investigator: Daniel Truong, MD | |
| United States, Colorado | |
| University of Colorado, Denver | Recruiting |
| Denver, Colorado, United States, 80045 | |
| Contact: Erika Shelton 303-724-5865 erika.shelton@ucdenver.edu | |
| Principal Investigator: Brian D. Berman, MD | |
| United States, Florida | |
| University of Florida, Gainesville | Recruiting |
| Gainesville, Florida, United States, 32611 | |
| Contact: Kyle Rizer 352-294-5194 kyle.rizer@neurology.ufl.edu | |
| Principal Investigator: Ramon Rodriguez, MD | |
| Sub-Investigator: Michael Okun, MD | |
| United States, Georgia | |
| Emory University | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Ami R Rosen, MS, CGC 404-727-3381 arosen3@emory.edu | |
| Principal Investigator: H. A. Jinnah, MD, PhD | |
| Sub-Investigator: Stewart Factor, DO | |
| Sub-Investigator: Michael Johns, MD | |
| United States, Illinois | |
| Rush University | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Tracy Waliczek 312-563-2848 Tracy_Waliczek@rush.edu | |
| Principal Investigator: Cynthia Comella, MD | |
| Principal Investigator: Christopher Goetz, MD | |
| University of Chicago | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Joan Young, CCRP 773-834-1688 jyoung@neurology.bsd.uchicago.edu | |
| Principal Investigator: Tao Xie, PhD | |
| Bastian Voice Institute | Not yet recruiting |
| Downers Grove, Illinois, United States, 60515 | |
| Contact: Elga Heintzen, RN susan.leibforth@bastianvoice.com | |
| Principal Investigator: Robert Bastian, MD | |
| United States, Maryland | |
| University of Maryland | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Katherine Holmes 410-328-4892 kholmes@som.umaryland.edu | |
| Contact: Samantha Gibson 410-328-4349 sagibson@som.umaryland.edu | |
| Principal Investigator: Stephen Reich, MD | |
| National Institutes of Health | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: Vesper Ramos, MD ramosvl@mail.nih.gov | |
| Contact: Gayle McCrossin 301-480-2286 mccrossing@ninds.nih.gov | |
| Principal Investigator: Mark Hallett, MD | |
| Parkinson's and Movement Disorders Center of Maryland | Recruiting |
| Elkridge, Maryland, United States, 21075 | |
| Contact: Nicole Saunders, RN 443-755-0030 nsaunders@pdmdcenter.com | |
| Principal Investigator: Stephen Grill, MD, PhD | |
| United States, Missouri | |
| Washington University in St. Louis | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Ling Yan, PhD 314-362-7148 yanling@npg.wustl.edu | |
| Principal Investigator: Joel Perlmutter, MD | |
| Sub-Investigator: Randy Paniello, MD | |
| United States, New Mexico | |
| University of New Mexico | Recruiting |
| Albuquerque, New Mexico, United States, 87113 | |
| Contact: Margaret Radigan 505-272-8740 mradigan@salud.unm.edu | |
| Principal Investigator: Sarah Pirio Richardson, MD | |
| United States, New York | |
| Beth Israel Medical Center | Recruiting |
| New York, New York, United States, 10003 | |
| Contact: Emily Muller, CCRP 212-844-6571 emuller@chpnet.org | |
| Principal Investigator: William Lawrence Severt, MD | |
| University of Rochester | Recruiting |
| Rochester, New York, United States, 14618 | |
| Contact: Michael Bull 585-275-2367 MichaelT_Bull@urmc.rochester.edu | |
| Principal Investigator: Richard Barbano, MD, PhD | |
| United States, North Carolina | |
| Wake Forest | Recruiting |
| Winston Salem, North Carolina, United States, 27157 | |
| Contact: Janet Hutchens, BS, CCRC 336-716-1715 jahutche@wakehealth.edu | |
| Principal Investigator: Allison Brashear, MD | |
| Sub-Investigator: Ihtsham Haq, MD | |
| Sub-Investigator: Mustafa Siddiqui, MD | |
| Sub-Investigator: Francis Walker, MD | |
| United States, Ohio | |
| University of Cincinnati | Recruiting |
| Cincinnati, Ohio, United States, 45219 | |
| Contact: Jaya Mishra, PhD 513-558-0169 mishraja@ucmail.uc.edu | |
| Principal Investigator: Alberto Espay, MD, MSc | |
| Sub-Investigator: Fredy Revilla, MD | |
| Cleveland Clinic Foundation | Not yet recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Yvette Pitchford 216-444-7513 ellisy@ccf.org | |
| Principal Investigator: Richard Lederman, MD, PhD | |
| United States, South Dakota | |
| Sanford Health | Not yet recruiting |
| Sioux Falls, South Dakota, United States, 57104 | |
| Contact: Jessica Vandermark 605-328-1373 jessica.vandermark@sanfordhealth.org | |
| Principal Investigator: Michael Kruer, MD | |
| United States, Tennessee | |
| University of Tennessee | Recruiting |
| Memphis, Tennessee, United States, 38163 | |
| Contact: Kate Marshall 901-448-6180 kmarsh14@uthsc.edu | |
| Principal Investigator: Mark S. LeDoux, MD, PhD | |
| United States, Texas | |
| Baylor College of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Lea Kiefer 713-798-3951 kiefer@bcm.edu | |
| Principal Investigator: Laura Marsh, MD | |
| Sub-Investigator: Joseph Jankovic, MD | |
| Sub-Investigator: Salah Qureshi, MD | |
| University of Texas | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Sana Sarfaraz 713-500-7153 sana.sarfaraz@uth.tmc.edu | |
| Principal Investigator: William Ondo, MD | |
| United States, Virginia | |
| James Madison University | Active, not recruiting |
| Harrisonburg, Virginia, United States, 22807 | |
| Virginia Commonwealth University | Recruiting |
| Richmond, Virginia, United States, 23298 | |
| Contact: Ginger Norris, MGC 804-828-0870 vwnorris@vcu.edu | |
| Principal Investigator: Claudia Testa, MD, PhD | |
| United States, Wisconsin | |
| Medical College of Wisconsin | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: Carrie Kalata, SLP 414-805-5638 ckalata@mcw.edu | |
| Principal Investigator: Joel Blumin, MD, FACS | |
| Sub-Investigator: Karen Blindauer, MD | |
| Canada, Alberta | |
| University of Alberta | Recruiting |
| Edmonton, Alberta, Canada, T6G 2B7 | |
| Contact: Paul McCann 780-407-1614 paul.mccann@albertahealthservices.ca | |
| Principal Investigator: Oksana Suchowersky, MD | |
| Canada, Ontario | |
| Toronto Western Hospital | Recruiting |
| Toronto, Ontario, Canada, MST 258 | |
| Contact: Brandon Rothberg 416-603-5800 ext 3120 brothber@uhnresearch.ca | |
| Principal Investigator: Susan Fox, MD, PhD | |
| Sub-Investigator: Mateusz Zurowski, MD | |
| Canada, Quebec | |
| Centre Hospitalier de l'Universite de Montreal | Recruiting |
| Montreal, Quebec, Canada, H2C 4M1 | |
| Contact: Monica Beland 514-890-8000 ext 26512 monica.beland.chum@ssss.gouv.qc.ca | |
| Principal Investigator: Sylvain Chouinard, MD, FRCPc | |
| Germany | |
| University of Luebeck | Recruiting |
| Luebeck, Germany, 23562 | |
| Contact: Alexander Schmidt +49-451-2903-354 alexander.schmidt@neuro.uni-luebeck.de | |
| Principal Investigator: Christine Klein, MD | |
| United Kingdom | |
| University College London Institute of Neurology | Recruiting |
| London, United Kingdom, WC1N 3BG | |
| Contact: Amit Batla, MD 0203 448 8607 amit.batla@uclh.nhs.uk | |
| Principal Investigator: Kailash Bhatia, FRCP | |
Sponsors and Collaborators
Hyder A. Jinnah, MD, PhD
Allergan
Dystonia Study Group
Investigators
| 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: | RDCRN#6301, 1U54NS065701 |
| Study First Received: | June 2, 2011 |
| Last Updated: | May 6, 2013 |
| 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 Voice Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases |
Signs and Symptoms Movement Disorders Central Nervous System Diseases Laryngeal Diseases Respiratory Tract Diseases Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013