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

Brief Title

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

Official Title

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

Brief Summary

      Central Nervous System (CNS) demyelinating conditions include multiple sclerosis (MS), Acute
      Disseminated Encephalomyelitis (ADEM), Neuromyelitis Optica Spectrum Disorder (NMOSD) 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 18 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 +/- 2 months. Each study visit will have the
      same neuropsychological, OCT, and research MRI examinations.
    


Study Type

Observational


Primary Outcome

MRI Brain without contrast

Secondary Outcome

 Change in Examination of Optical Coherence Tomography

Condition

Multiple Sclerosis, Relapsing-Remitting


Study Arms / Comparison Groups

 CNS demyelinating diagnosis
Description:  Diagnosis of CNS demyelinating disorder: Multiple Sclerosis, Transverse Myelitis, Neuromyelitis Optica, Acute Disseminated Encephalomyelitis, anti-MOG antibody.
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 later

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

160

Start Date

October 22, 2019

Completion Date

May 31, 2024

Primary Completion Date

May 31, 2023

Eligibility Criteria

        Inclusion Criteria:

          1. Diagnosis of Multiple Sclerosis , ADEM, anti-MOG antibody associated CNS demyelination

          2. Age 12 to 18 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 and older 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, pregnant, the presence of metallic braces, implants or medical devices
             that are unsafe at 3T or 7T and/or interfere with the MRI/MRS signals
      

Gender

All

Ages

12 Years - 18 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Benjamin Greenberg, MD. MHS, 214-456-2464, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03942952

Organization ID

STU-2019-0491


Responsible Party

Principal Investigator

Study Sponsor

University of Texas Southwestern Medical Center


Study Sponsor

Benjamin Greenberg, MD. MHS, Principal Investigator, University Texas Southwestern


Verification Date

November 2020