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

The University of Texas System (UT)

Status: Completed

Conditions: Neuromyelitis Optica; Multiple Sclerosis, Relapsing-Remitting; Transverse Myelitis; Acute Disseminated Encephalomyelitis

Study type: Observational

Funder types: Other

Identifiers

NCT03942952

STU-2019-0491

Details and patient eligibility

About

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.

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.

Enrollment: 49 patients

Sex: All

Ages: 12 to 21 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Known history of traumatic brain injury that required medical care
2. Non-English speaking (based on standardized neuropsychological testing and questionnaires)
3. 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

Trial design

49 participants in 2 patient groups

CNS demyelinating diagnosis

Description:

Diagnosis of CNS demyelinating disorder: Multiple Sclerosis, Transverse Myelitis, Neuromyelitis Optica, Acute Disseminated Encephalomyelitis, anti-MOG antibody, Optic Neuritis. * 3T and 7T MRI * Neuropsychological testing * Optical Coherence Tomography * Questionnaires: Quality of Life and Behavior scales * Non invasive clinical assessment : Walking, hand and eye coordination tests Repeat same research activities one to year and a half year later

Healthy Control

Description:

* 3T and 7T MRI * Neuropsychological testing * Optical Coherence Tomography * Questionnaires: Quality of Life and Behavior scales * Non invasive clinical assessment : Walking, hand and eye coordination tests Repeat same research activities one year to a year and a half later