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

NCT03942952 | Completed

• 1 other identifier: STU-2019-0491
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Multiple Sclerosis; NMO; anti-MOG; Acute Disseminated Encephalolmyelitis

Outcome Measures

Primary Outcomes (20)

• MRI Brain without contrast

  3T MRI

  10-14 months

• MRI Brain without contrast

  7T MRI

  10-14 months

• Change in Score of Delis-Kaplan Executive Function System (D-KEFS) Color

  Executive Functioning

  10-14 months

• Change in Score of Word Interference Test (CWIT)

  Executive Functioning

  10-14 months

• Change in Score of Symbol Digit Modalities (SDMT)- Oral Version

  Processing Speed

  10-14 months

• Change in Score of Beery-Buktencia Developmental Test of Visual-Motor Integration, Sixth Edition (VMI-6)

  Visual-Motor Integration

  10-14 months

• Change in Score of Wechsler Intelligence Scale for Children-5th edition (WISCV)

  Simple Auditory Attention

  10-14 months

• Change in Score of Wechsler Adult Intelligence Scale-Fourth edition (WAIS-IV) Digits Forward

  Simple Auditory Attention

  10-14 months

• Change in Score of WISC-V or WAIS-IV Digits Backward

  Working Memory

  10-14 months

• Change in Score of California Verbal Learning Test- Children's Version (CVLT-C) or California Verbal Learning Test-Second Edition (CVLT-II)

  Verbal Learning and Memory

  10-14 months

• Change i Score of D-KEFS Letter and Category Fluency

  Verbal Fluency

  10-14 months

• Change in Score of WASI-II

  Estimate of IQ

  10-14 months

• Change in Score of Woodcock-Johnson Tests of Achievement Letter Word identification

  Basic Reading Skill

  10-14 months

• Change in Score of Reading Fluency

  Reading Speed

  10-14 months

• Change in Score of Calculation

  Math Calculation Skills

  10-14 months

• Change in Score of Math Fluency

  Math Speed

  10-14 months

• Change in Score of Word Attack

  Phoneme/Grapheme Knowledge

  10-14 months

• Change in Score of Grooved Pegboard

  Bilateral Fine Motor Speed and Dexterity

  10-14 months

• Change in Score of Trail Making Test, Part A and B

  Simple and complex Attention

  10-14 months

• Change in Score of Conners Continuous Performance Test 3rd Edition

  Sustained Attention and Behavioral Inhibition

  10-14 months

Secondary Outcomes (11)

• Change in Examination of Optical Coherence Tomography

  10-14 months

• Change in PROMIS Mobility score

  10-14 months

• Change in PROMIS Pain score

  10-14 months

• Change in PROMIS Peer relationship score

  10-14 months

• Change in PROMIS Stress score

  10-14 months

Study Arms (2)

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

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

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Teenagers before 22 at the time of consent diagnosis with a Central Nervous System demyelinating disorder.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University Texas Southwestern

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Eye Diseases; Leukoencephalopathies; Brain Diseases; Central Nervous System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myelitis; Central Nervous System Infections; Infections; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Spinal Cord Diseases; Neurodegenerative Diseases; Neuroinflammatory Diseases

Study Officials

• Benjamin Greenberg, MD. MHS

  University Texas Southwestern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: May 8, 2019
• Study Start: October 22, 2019
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: September 5, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)