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

NCT ID: NCT03942952

Last Updated: 2023-09-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 49 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-22
• Study Completion Date: 2023-06-30

Brief 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.

Detailed 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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

CNS demyelinating diagnosis

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

No interventions assigned to this group

Healthy Control

• 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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Benjamin Greenberg

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benjamin Greenberg, MD. MHS

Role: PRINCIPAL_INVESTIGATOR

University Texas Southwestern

Locations

University Texas Southwestern

Dallas, Texas, United States

Countries

United States

Other Identifiers

STU-2019-0491

Identifier Type: -

Identifier Source: org_study_id