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Completed

NCT Number: NCT03942952

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

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.

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Key information

Conditions

Multiple Sclerosis, Relapsing-Remitting Acute Disseminated Encephalomyelitis Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Central Nervous System Diseases Central Nervous System Infections Chronic Disease Cranial Nerve Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Encephalomyelitis, Acute Disseminated Eye Diseases Immune System Diseases Infections Leukoencephalopathies Multiple Sclerosis Myelitis Myelitis, Transverse Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurodegenerative Diseases Neuroinflammatory Diseases Neuromyelitis Optica Optic Nerve Diseases Optic Neuritis Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System Pathologic Processes Pathological Conditions, Signs and Symptoms Post-Infectious Disorders Spinal Cord Diseases Transverse Myelitis

Age range

12 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Texas Southwestern

Dallas, Texas, 75390, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. MRI Brain without contrast

    Time frame: 10-14 months

    3T MRI

  2. MRI Brain without contrast

    Time frame: 10-14 months

    7T MRI

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

    Time frame: 10-14 months

    Executive Functioning

  4. Change in Score of Word Interference Test (CWIT)

    Time frame: 10-14 months

    Executive Functioning

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

    Time frame: 10-14 months

    Processing Speed

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

    Time frame: 10-14 months

    Visual-Motor Integration

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

    Time frame: 10-14 months

    Simple Auditory Attention

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

    Time frame: 10-14 months

    Simple Auditory Attention

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

    Time frame: 10-14 months

    Working Memory

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

    Time frame: 10-14 months

    Verbal Learning and Memory

  11. Change i Score of D-KEFS Letter and Category Fluency

    Time frame: 10-14 months

    Verbal Fluency

  12. Change in Score of WASI-II

    Time frame: 10-14 months

    Estimate of IQ

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

    Time frame: 10-14 months

    Basic Reading Skill

  14. Change in Score of Reading Fluency

    Time frame: 10-14 months

    Reading Speed

  15. Change in Score of Calculation

    Time frame: 10-14 months

    Math Calculation Skills

  16. Change in Score of Math Fluency

    Time frame: 10-14 months

    Math Speed

  17. Change in Score of Word Attack

    Time frame: 10-14 months

    Phoneme/Grapheme Knowledge

  18. Change in Score of Grooved Pegboard

    Time frame: 10-14 months

    Bilateral Fine Motor Speed and Dexterity

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

    Time frame: 10-14 months

    Simple and complex Attention

  20. Change in Score of Conners Continuous Performance Test 3rd Edition

    Time frame: 10-14 months

    Sustained Attention and Behavioral Inhibition

Secondary outcomes

  1. Change in Examination of Optical Coherence Tomography

    Time frame: 10-14 months

    Eye examination

  2. Change in PROMIS Mobility score

    Time frame: 10-14 months

    Patient Reported Outcomes Measures: Mobility, walking

  3. Change in PROMIS Pain score

    Time frame: 10-14 months

    Patient Reported Outcomes Measures: overall pain level

  4. Change in PROMIS Peer relationship score

    Time frame: 10-14 months

    Patient Reported Outcomes Measures: Peer relationships

  5. Change in PROMIS Stress score

    Time frame: 10-14 months

    Patient Reported Outcomes Measures: Psychological stress

  6. Change in PROMIS Upper extremity movement score

    Time frame: 10-14 months

    Patient Reported Outcomes Measures: Upper extremity movement

  7. Change in score of 25 foot timed walk

    Time frame: 10-14 months

    Walking speed

  8. Change in score of 6 minute timed walk

    Time frame: 10-14 months

    Walking Distance

  9. Change in score of Hauser Ambulation Index

    Time frame: 10-14 months

    Functional walking assessment

  10. Change in score of Multiple Sclerosis Functional Capacity (MSFC)

    Time frame: 10-14 months

    Hand and Eye coordination, Memory test

  11. Change in score of Modified Rankin Scale

    Time frame: 10-14 months

    Disability scale

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Acronym: SONICS

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 8, 2019
Registry last updated
Sep 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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