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Natural History, Diagnosis, and Outcomes for Leukodystrophies

Natural History, Diagnosis, and Outcomes for Leukodystrophies

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Phase N/A

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Overview

The goals of this protocol is to diagnose, care for, and understand the clinical histories and outcomes of people with leukodystrophies.

Description

Inherited leukodystrophies affect close to 1 in 7500 children with mortality greater than 30%. Affected patients face additional serious medical complications including epilepsy, developmental regression, and intellectual disabilities. Diagnosis is difficult and requires the assistance of a specialist. Finally, identifying treatments and improving outcomes is complex.

The Western Leukodystrophy Project, which is part of the University of Utah and of Primary Children's Hospital, and which is a certified Leukodystrophy Care Network Center, provides a specialized resource for patients with leukodystrophies.

This clinical study assists with diagnosis of leukodystrophies; suggesting treatment options and implementing care guidelines, and improving outcomes for all patients by understanding the clinical histories and outcomes of affected patients..

Eligibility

Inclusion Criteria:

  • evidence by clinical exam, radiological findings, and/or testing, of an inherited leukodystrophy.
  • be able to travel to the leukodystrophy clinic (at Primary Children's Hospital, Salt Lake City, Utah);
  • be able to tolerate a general physical exam, and a neurological exam.

Exclusion Criteria:

  • unable to be evaluated at the University of Utah Hospital or Primary Children's Hospital;
  • refusal to sign study consent form;
  • evidence or finding of another non-genetic cause of their condition;
  • Persons with known white matter disease or lesions related to: birth injury or prenatal injury, multiple sclerosis, trauma, infection, immunization, or post-infectious effects (e.g. ADEM- acute disseminated encephalomyelitis), metabolic disturbance (e.g. Central pontine myelinolysis), neoplasms, primary rheumatologic diseases (e.g. Systemic lupus erythematosis), stroke, hypoxic-ischemic injury, drug or toxin effect, seizures, or endocrine disturbance.

Study details
    Leukodystrophy

NCT03639285

University of Utah

26 January 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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