DystoniaDCPNCT01373424
The Dystonia Coalition Natural History and Biospecimen Repository for Isolated Dystonias
An observational study of Dystonia, run by Emory University at 42 sites in 7 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dystonia
- How many people
- 3,265 participants
- Where
- 42 sitesin 7 countries
- Study dates
- Jan 2011to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
42 sites in 7 countries.
42 sites in 7 countries
United States34 sites
University of New Mexico
Albuquerque, New Mexico, 87113
Emory University
Atlanta, Georgia, 30322
University of Maryland
Baltimore, Maryland, 21201
Johns Hopkins University
Baltimore, Maryland, 21287
National Institutes of Health
Bethesda, Maryland, 20892
University of Alabama, Birmingham
Birmingham, Alabama, 35233
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
Rush University
Chicago, Illinois, 60612
University of Chicago
Chicago, Illinois, 60637
University of Cincinnati
Cincinnati, Ohio, 45219
University of Texas, Southwestern
Dallas, Texas, 75390
University of Colorado, Denver
Denver, Colorado, 80045
Parkinson's and Movement Disorders Center of Maryland
Elkridge, Maryland, 21075
Sanford Health - Fargo
Fargo, North Dakota, 58103
Parkinson's and Movement Disorders Institute
Fountain Valley, California, 72708
University of Florida, Gainesville
Gainesville, Florida, 32611
James Madison University
Harrisonburg, Virginia, 22807
Baylor College of Medicine
Houston, Texas, 77030
Houston Methodist Neurological Institute
Houston, Texas, 77030
University of Texas
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
Booth Gardner Parkinson's Care Center
Kirkland, Washington, 98034
University of California, San Diego
La Jolla, California, 92037
University of Tennessee
Memphis, Tennessee, 38163
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Mount Sinai Beth Israel
New York, New York, 10003
Mount Sinai Medical Center
New York, New York, 10029
University of Pennsylvania, Parkinson's Disease and Movement Disorders Center
Philadelphia, Pennsylvania, 19107
Virginia Commonwealth University
Richmond, Virginia, 23298
University of Rochester
Rochester, New York, 14618
Mayo Clinic, Arizona
Scottsdale, Arizona, 85259
Washington University in St. Louis
St Louis, Missouri, 63110
Wake Forest
Winston-Salem, North Carolina, 27157
Canada3 sites
University of Alberta
Edmonton, Alberta, T6G 2B7
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2C 4M1
Toronto Western Hospital
Toronto, Ontario, MST 258
United Kingdom1 site
University College London Institute of Neurology
London, WC1N 3BG
About this study
Official title: Natural History and Biospecimen Repository for Dystonia; Comprehensive Rating Tools for Cervical Dystonia; Validity & Reliability of Diagnostic Methods & Measures of Spasmodic Dysphonia
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.
Read the 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.
- Conditions
- Dystonia
- Keywords
- Observational study, Cross-sectional and Prospective study, Cohort and case-control study
- Medical subject headings
- Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 - enrollment for this group is complete | |
| Craniofacial dystonia | People diagnosed with craniofacial dystonia (including blepharospasm, meige syndrome, and oromandibular dystonia) | |
| Limb dystonia | People diagnosed with limb dystonia | |
| All other isolated dystonias | People diagnosed with any isolated dystonia not listed in descriptions of other cohorts | |
| Myoclonus dystonia | People diagnosed with myoclonus dystonia | |
| Dopa-responsive dystonia | People diagnosed with dopa-responsive dystonia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observational
There is no primary outcome measure as this is an observational study.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2011 (estimated)
- Study startJan 2011
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DystoniaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 3,265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Office of Rare Diseases (ORD), Allergan, Dystonia Study Group
- Responsible party
- Principal investigator, Hyder A. Jinnah, MD, PhD, Emory University
- Investigators
- H. A. Jinnah, MD, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01373424
- Sponsor's protocol ID
- IRB00046266
- Other IDs
- U54TR001456, RDCRN#6301, U54NS065701
- Acronym
- DCP
- Status last verified
- Oct 2020
- First submitted
- 2 Jun 2011
- Last updated
- 26 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Patel N, Hanfelt J, Marsh L, Jankovic J; members of the Dystonia Coalition. Alleviating manoeuvres (sensory tricks) in cervical dystonia. J Neurol Neurosurg Psychiatry. 2014 Aug;85(8):882-4. doi: 10.1136/jnnp-2013-307316. Epub 2014 May 14.
PubMed 24828895
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History and Biospecimen Repository for Dystonia; Comprehensive Rating Tools for Cervical Dystonia; Validity & Reliability of Diagnostic Methods & Measures of Spasmodic Dysphonia
- ClinicalTrials.gov ID
- NCT01373424
- Acronym / sponsor ID
- DCP / IRB00046266
- Conditions
- Dystonia
- Keywords
- Observational study, Cross-sectional and Prospective study, Cohort and case-control study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,265 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Office of Rare Diseases (ORD), Allergan, Dystonia Study Group
- Study start
- Jan 2011
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 15 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 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 - enrollment for this group is complete |
| Craniofacial dystonia | – | –People diagnosed with craniofacial dystonia (including blepharospasm, meige syndrome, and oromandibular dystonia) |
| Limb dystonia | – | –People diagnosed with limb dystonia |
| All other isolated dystonias | – | –People diagnosed with any isolated dystonia not listed in descriptions of other cohorts |
| Myoclonus dystonia | – | –People diagnosed with myoclonus dystonia |
| Dopa-responsive dystonia | – | –People diagnosed with dopa-responsive dystonia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Observational
Time frame: 7 years
There is no primary outcome measure as this is an observational study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
- Derived from this study: PubMed 24828895Patel N, Hanfelt J, Marsh L, Jankovic J; members of the Dystonia Coalition. Alleviating manoeuvres (sensory tricks) in cervical dystonia. J Neurol Neurosurg Psychiatry. 2014 Aug;85(8):882-4. doi: 10.1136/jnnp-2013-307316. Epub 2014 May 14.
- Dystonia Coalition websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Dystonia
Recruiting
Impact of rTMS on Abnormal Cortical fMRI in Patients With Dystonia
Dystonia Disorder
Recruiting
Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
Recruiting
Focused Ultrasound Unilateral Pallidotomy for Medication-Refractory Limb Dystonia
Limb Dystonia, Idiopathic Dystonia
Recruiting
Deep Brain Stimulation Surgery for Movement Disorders
Parkinson's Disease, Essential Tremor
Active, not recruitingPhase 1/2
Deep Brain Stimulation Surgery for Focal Hand Dystonia
Dystonia, Focal Dystonia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
H. A. Jinnah, MD, PhD principal investigator
Emory University
42 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dystonia, run by Emory University at 42 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States, Canada, Australia, France, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observational (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01373424, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2020.