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Imaging Genetics of Laryngeal Dystonia

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Primary and study completion dates: Jul 31, 2027 to Jul 31, 2028
    • Site contact updated
    • Publications: details revised at 10 of 11 entries
    v11
  2. Site contact updated
    • Publications: details revised at 10 of 11 entries
    v10
  3. Re-verified, no change to tracked fieldsv9
  4. Primary endpoint revisedv8 Show 7 more changesShow less
    • Enrollment target: 298 to 410
    • Primary and study completion dates: Feb 28, 2027 to Jul 31, 2027
    • Eligibility criteria shortened, about 189 words
    • Secondary endpoint revised
    • Study description shortened, about 21 words
    • Study title revised
    • Study arms: 3 to 4
  5. Primary and study completion dates: Feb 28, 2022 to Feb 28, 2027v7
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  1. 3 versions Re-verified since Jan 4, 2019, no change to tracked fieldsv4-v6
  2. Site contact updatedv3
  3. Lead sponsor: Icahn School of Medicine at Mount Sinai to Kristina Simonyanv2 Show 6 more changesShow less
    • Primary endpoints: 2 to 1
    • Eligibility criteria revised
    • Study site revised
    • Collaborators: 2 to 1
    • Publications: 1 to 11
    • Secondary endpoints expanded, about 4 words
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The contribution of genetic risk factors to the development of focal dystonias is evident. However, understanding of how variations in the causative gene expression lead to variations in brain abnormalities in different phenotypes of dystonia (e.g., familial, sporadic) remains limited. The research program of the investigators is set to determine the relationship between brain changes and genetic risk factors in laryngeal dystonia (or spasmodic dysphonia). The researchers use a novel approach of combined imaging genetics, next-generation DNA sequencing, and clinical-behavioral testing. The use of a cross-disciplinary approach as a tool for the discovery of the mediating neural mechanisms that bridge the gap from DNA sequence to the pathophysiology of dystonia holds a promise for the understanding of the mechanistic aspects of brain function affected by risk gene variants, which can be used reliably for the discovery of associated genes and neural integrity markers for this disorder. The expected outcome of this study may lead to better clinical management of this disorder, including its improved detection, accurate diagnosis, and assessment of the risk of developing dystonia in family members.
Trial Details
NCT Number NCT03042975
Lead Sponsor Kristina Simonyan
Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
Conditions
(from sponsor)		 Laryngeal Dystonia, Unaffected Relatives of Laryngeal Dystonia Patients, Voice Tremor, Muscle Tension Dysphonia
Related terms Dysphonia, Dystonia
Enrollment 410 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov