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

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ClinicalTrials.gov Identifier: NCT03942952
Recruitment Status : Recruiting
First Posted : May 8, 2019
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
Benjamin Greenberg, University of Texas Southwestern Medical Center

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.

Condition or disease
Multiple Sclerosis, Relapsing-Remitting Neuromyelitis Optica Acute Disseminated Encephalomyelitis Transverse Myelitis

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.

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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PEDIATRIC SONICS: Pediatric Study of Neuropsychology and Imaging in CNS Demyelinating Syndromes.
Estimated Study Start Date : September 24, 2019
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : May 31, 2023


Group/Cohort
CNS demyelinating diagnosis

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
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 later



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Teenagers before 18 at the time of consent diagnosis with a Central Nervous System demyelinating disorder.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03942952


Contacts
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Contact: Janetta Stockdale, RN 214-456-3696 janetta.stockdale@utsouthwestern.edu
Contact: Patricia Plumb, RN 214-456-2464 patricia.plumb@utsouthwestern.edu

Locations
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United States, Texas
University Texas Southwestern Recruiting
Dallas, Texas, United States, 75235
Contact: Janetta Stockdale, RN, BSN    214-645-0543    janetta.stockdale@utsouthwestern.edu   
Contact: Tricia Plumb, RN, MSN    214-456-2464    patricia.plumb@utsouthwestern.edu   
Principal Investigator: Benjamin Greenberg, MD, MHS         
Sub-Investigator: Lana Harder, PhD, ABPP         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Benjamin Greenberg, MD. MHS University Texas Southwestern

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Responsible Party: Benjamin Greenberg, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03942952     History of Changes
Other Study ID Numbers: STU-2019-0491
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Benjamin Greenberg, University of Texas Southwestern Medical Center:
Multiple Sclerosis
NMO
anti-MOG
Acute Disseminated Encephalolmyelitis
Additional relevant MeSH terms:
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Neuromyelitis Optica
Paraneoplastic Syndromes, Nervous System
Paraneoplastic Syndromes
Myelitis, Transverse
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Encephalomyelitis
Myelitis
Encephalomyelitis, Acute Disseminated
Sclerosis
Pathologic Processes
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
Central Nervous System Infections
Central Nervous System Diseases
Spinal Cord Diseases
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Neurodegenerative Diseases
Leukoencephalopathies
Brain Diseases