DystoniaNCT04156022
Dystonia Coalition Projects
An observational study of Dystonia, run by University of Texas Southwestern Medical Center.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Dystonia
- What is being tested?
- Dystonia Coalition is an observational study.
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2015to 1 Aug 2017
- 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 to 99 years
- 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 primary dystonia
- To be included in laryngeal dystonia group, nasolaryngoscopy (voice box exam) must have been completed to confirm diagnosis
Who cannot join
- -Any person with secondary dystonia
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 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.
Read the 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. A study visit will take between 45 minutes and 1 hour depending upon which portions of the study a subject completes. A subset of subjects will be asked to return no more often than once a year for a one hour follow-up visit.
- Conditions
- Dystonia
- Being tested
- Dystonia Coalition is an observational study.
- Keywords
- Cervical dystonia, Cranial dystonia, Limb dystonia
- Medical subject headings
- Dystonia, Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dystonia Coalition is an observational study.Other
This is not an interventional study.
What is being measured
The primary outcome is the main question the study is designed to answer.
To collect clinical data for future studies that will help to understand the varied clinical manifestations, natural history, and pathogenesis of the dystonias.
data collected will be demographic and medical information
Measured: Through study completion, an average of two years.
To create a biospeciman repository as a resource for future research in dystonia and related diseases
Measured: Through study completion, an average of two years.
To develop and validate rating scales that can be used to diagnose different forms of dystonia and monitor their severity over time
a six phase process will be employed to develop and evaluate a scale that is specifically designed to assess psychiatric co-morbidities in cervical dysplasia (CD)
Measured: Through study completion, an average of two years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start1 May 2015
- Primary completion1 Aug 2017
- Study completion1 Aug 2017
Why it stopped: PI request due to a lack of coordinator availability for study procedures.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DystoniaStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Other
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04156022
- Sponsor's protocol ID
- 6301
- Status last verified
- Nov 2019
- First submitted
- 8 Jan 2019
- Last updated
- 7 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2019. 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
- NCT04156022
- Acronym / sponsor ID
- 6301
- Conditions
- Dystonia
- Keywords
- Cervical dystonia, Cranial dystonia, Limb dystonia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI request due to a lack of coordinator availability for study procedures.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Emory University
- Study start
- 1 May 2015 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 7 Nov 2019 (actual)
- 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 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.
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. A study visit will take between 45 minutes and 1 hour depending upon which portions of the study a subject completes. A subset of subjects will be asked to return no more often than once a year for a one hour follow-up visit.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 99 years
- 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 primary dystonia
- To be included in laryngeal dystonia group, nasolaryngoscopy (voice box exam) must have been completed to confirm diagnosis
Key exclusion criteria (1 listed)
- -Any person with secondary dystonia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dystonia Coalition is an observational study.This is not an interventional study. | Other | – |
Primary outcome
To collect clinical data for future studies that will help to understand the varied clinical manifestations, natural history, and pathogenesis of the dystonias.
Time frame: Through study completion, an average of two years.
data collected will be demographic and medical information
To create a biospeciman repository as a resource for future research in dystonia and related diseases
Time frame: Through study completion, an average of two years.
To develop and validate rating scales that can be used to diagnose different forms of dystonia and monitor their severity over time
Time frame: Through study completion, an average of two years.
a six phase process will be employed to develop and evaluate a scale that is specifically designed to assess psychiatric co-morbidities in cervical dysplasia (CD)
Results and safety
The study was stopped early (reason given: PI request due to a lack of coordinator availability for study procedures.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Dystonia, run by University of Texas Southwestern Medical Center.
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 1 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: stopped early, as of the sponsor's last update on 7 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: PI request due to a lack of coordinator availability for study procedures.). Results are not available in the source record.
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?
To collect clinical data for future studies that will help to understand the varied clinical manifestations, natural history, and pathogenesis of the dystonias. (time frame: Through study completion, an average of two years.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2019; AzTrials last refreshed its copy on 27 Oct 2026.