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

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.

Study Overview

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

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.

• Study Type: Observational
• Enrollment (Actual): 49

Contacts and Locations

• Study Contact: Name: Tricia Plumb, RN, MSN; Phone Number: 214-456-2464; Email: patricia.plumb@utsouthwestern.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • University Texas Southwestern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Examination of Optical Coherence Tomography	Eye examination	10-14 months
Change in PROMIS Mobility score	Patient Reported Outcomes Measures: Mobility, walking	10-14 months
Change in PROMIS Pain score	Patient Reported Outcomes Measures: overall pain level	10-14 months
Change in PROMIS Peer relationship score	Patient Reported Outcomes Measures: Peer relationships	10-14 months
Change in PROMIS Stress score	Patient Reported Outcomes Measures: Psychological stress	10-14 months
Change in PROMIS Upper extremity movement score	Patient Reported Outcomes Measures: Upper extremity movement	10-14 months
Change in score of 25 foot timed walk	Walking speed	10-14 months
Change in score of 6 minute timed walk	Walking Distance	10-14 months
Change in score of Hauser Ambulation Index	Functional walking assessment	10-14 months
Change in score of Multiple Sclerosis Functional Capacity (MSFC)	Hand and Eye coordination, Memory test	10-14 months
Change in score of Modified Rankin Scale	Disability scale	10-14 months

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Benjamin Greenberg, MD. MHS, University Texas Southwestern

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2019
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: April 22, 2019
• First Submitted That Met QC Criteria: May 7, 2019
• First Posted (Actual): May 8, 2019

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; NMO; anti-MOG; Acute Disseminated Encephalolmyelitis
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infections; Immune System Diseases; Neoplasms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Neoplasms by Site; Eye Diseases; Disease Attributes; Central Nervous System Infections; Neurodegenerative Diseases; Spinal Cord Diseases; Nervous System Neoplasms; Optic Nerve Diseases; Cranial Nerve Diseases; Paraneoplastic Syndromes, Nervous System; Paraneoplastic Syndromes; Optic Neuritis; Leukoencephalopathies; Chronic Disease; Neuroinflammatory Diseases; Post-Infectious Disorders; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Neuromyelitis Optica; Myelitis; Myelitis, Transverse; Encephalomyelitis; Encephalomyelitis, Acute Disseminated
• Other Study ID Numbers: STU-2019-0491

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No