NCT04156022

Brief 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 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2015

Typical duration for all trials

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2019

Completed
10 months until next milestone

First Posted

Study publicly available on registry

November 7, 2019

Completed
Last Updated

November 7, 2019

Status Verified

November 1, 2019

Enrollment Period

2.3 years

First QC Date

January 8, 2019

Last Update Submit

November 6, 2019

Conditions

Keywords

Cervical dystoniaCranial dystoniaLimb dystonia

Outcome Measures

Primary Outcomes (3)

  • 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

    Through study completion, an average of two years.

  • To create a biospeciman repository as a resource for future research in dystonia and related diseases

    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)

    Through study completion, an average of two years.

Interventions

This is not an interventional study.

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Diagnosed with primary dystonia
  • To be included in laryngeal dystonia group, nasolaryngoscopy (voice box exam) must have been completed to confirm diagnosis

You may not qualify if:

  • Any person with secondary dystonia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DystoniaTorticollis

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2019

First Posted

November 7, 2019

Study Start

May 1, 2015

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

November 7, 2019

Record last verified: 2019-11