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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03428009
Other study ID # STU 122017-069
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2018
Est. completion date September 2027

Study information

Verified date May 2024
Source University of Texas Southwestern Medical Center
Contact Jessica Clark
Phone 972.655.4847
Email jessica.clark@utsouthwestern.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to (1) investigate the effect of known dystonia-causing mutations on brain structure and function, to (2) identify structural brain changes that differ between clinical phenotypes of dystonia, and to (3) collect DNA, detailed family history, and clinical phenotypes from patients with idiopathic dystonia with the goal of identifying new dystonia-related genes. Investigators will be recruiting both healthy control subjects and subjects with any form of dystonia. For this study there will be a maximum of two study visit involving a clinical assessment, collection of medical and family history, task training session, an MRI using the learned tasks, and finally a blood draw for genetic analysis. In total, these visits will take 3-5 hours. If the dystonia subjects receive botulinum toxin injections for treatment, the participants and their matched controls will be asked to come for a second visit.


Description:

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Study Design


Related Conditions & MeSH terms

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Intervention

Other:
Magnetic Resonance Imaging
Study interventions are minimal risk.

Locations

Country Name City State
United States University of Texas Southwestern Medical Center Dallas Texas

Sponsors (2)

Lead Sponsor Collaborator
University of Texas Southwestern Medical Center Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Structural or functional imaging of dystonia and control groups Identify structural or functional imaging measures that distinguish (a) dystonia patients from matched controls, (b) between clinically-defined forms of dystonia 3-5 hours at each study visit
Primary Genetic Analysis of dystonia and control groups Identify polymorphisms in genes known to cause dystonia that affect the structural or functional imaging measures in dystonia patients and to identify new genes associated with dystonia. 30 min
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