Multiple Sclerosis Clinical Trial

PEDIATRIC SONICS: Pediatric Study of Neuropsychology and Imaging in CNS Demyelinating Syndromes.

Summary

Central Nervous System (CNS) demyelinating conditions include multiple sclerosis (MS), Acute Disseminated Encephalomyelitis (ADEM), Neuromyelitis Optica Spectrum Disorder (NMOSD), Optic Neuritis (ON) and Transverse Myelitis (TM). The symptoms of these conditions are quite variable from patient to patient, but can include motor, sensory, visual, gait and cognitive changes. Conventional MRI can be used to look for new anatomic changes, but fails to measure underlying biochemical changes in brain tissue. The purposes of this study are to identify the biologic and anatomic correlations between cognitive profiles and disease activity using MRI imaging techniques.

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Full Description

Pediatric patients (age 12 to 21 inclusive) with a diagnosis of multiple sclerosis, ADEM, anti-MOG mediated demyelinating disease as well as healthy controls will be recruited to undergo clinical testing. The study visits will include neuropsychological testing, optical coherence tomography (OCT) and MRI on both the 3T and 7T magnet. Subjects will be asked to undergo two study visits separated by 12 months to 18 months. Each study visit will have the same neuropsychological, OCT, and research MRI examinations.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Diagnosis of Multiple Sclerosis , ADEM, anti-MOG antibody associated CNS demyelination
Age 12 to 21 inclusive at time of enrollment
Ability of parent or legal guardian to provide informed consent if participant is under 18.
Ability of patients age 12-17 to give assent
Completion of the signed HIPPA authorization form by a parent or legal guardian or by participants (18 years of age).

Exclusion Criteria:

Known history of traumatic brain injury that required medical care
Non-English speaking (based on standardized neuropsychological testing and questionnaires)
Claustrophobic, the presence of metallic braces, implants or medical devices that are unsafe at 3T or 7T and/or interfere with the MRI/MRS signals

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

49

Study ID:

NCT03942952

Recruitment Status:

Completed

Sponsor:

University of Texas Southwestern Medical Center

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There is 1 Location for this study

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University Texas Southwestern
Dallas Texas, 75390, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

49

Study ID:

NCT03942952

Recruitment Status:

Completed

Sponsor:


University of Texas Southwestern Medical Center

How clear is this clinincal trial information?

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