Dystonia Coalition Projects (DCP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Emory University
National Institute of Neurological Disorders and Stroke (NINDS)
Office of Rare Diseases (ORD)
Dystonia Study Group
Information provided by (Responsible Party):
Hyder A. Jinnah, MD, PhD, Emory University
ClinicalTrials.gov Identifier:
First received: June 2, 2011
Last updated: June 24, 2015
Last verified: June 2015
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.

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:

Primary Outcome Measures:
  • 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: October 2015 (Final data collection date for primary outcome measure)
Cervical dystonia
People diagnosed with cervical dystonia
Laryngeal dystonia
People diagnosed with laryngeal dystonia
Other voice disorders
People diagnosed with a voice disorder other than laryngeal dystonia
Cranial dystonia
People diagnosed with cranial dystonia
Oromandibular dystonia
People diagnosed with oromandibular dystonia
Limb dystonia
People diagnosed with limb dystonia
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.


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.

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
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

Contact: Ami R Rosen, MS, CGC 404-727-3381 arosen3@emory.edu

  Show 41 Study Locations
Sponsors and Collaborators
Hyder A. Jinnah, MD, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Office of Rare Diseases (ORD)
Dystonia Study Group
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: June 24, 2015
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:
Dystonic Disorders
Voice Disorders
Central Nervous System Diseases
Laryngeal Diseases
Movement Disorders
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2015