PEDIATRIC SONICS: Pediatric Study of Neuropsychology and Imaging in CNS Demyelinating Syndromes.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Outcome Measures
Primary Outcome Measures
- MRI Brain without contrast [10-14 months]
3T MRI
- MRI Brain without contrast [10-14 months]
7T MRI
- Change in Score of Delis-Kaplan Executive Function System (D-KEFS) Color [10-14 months]
Executive Functioning
- Change in Score of Word Interference Test (CWIT) [10-14 months]
Executive Functioning
- Change in Score of Symbol Digit Modalities (SDMT)- Oral Version [10-14 months]
Processing Speed
- Change in Score of Beery-Buktencia Developmental Test of Visual-Motor Integration, Sixth Edition (VMI-6) [10-14 months]
Visual-Motor Integration
- Change in Score of Wechsler Intelligence Scale for Children-5th edition (WISCV) [10-14 months]
Simple Auditory Attention
- Change in Score of Wechsler Adult Intelligence Scale-Fourth edition (WAIS-IV) Digits Forward [10-14 months]
Simple Auditory Attention
- Change in Score of WISC-V or WAIS-IV Digits Backward [10-14 months]
Working Memory
- Change in Score of California Verbal Learning Test- Children's Version (CVLT-C) or California Verbal Learning Test-Second Edition (CVLT-II) [10-14 months]
Verbal Learning and Memory
- Change i Score of D-KEFS Letter and Category Fluency [10-14 months]
Verbal Fluency
- Change in Score of WASI-II [10-14 months]
Estimate of IQ
- Change in Score of Woodcock-Johnson Tests of Achievement Letter Word identification [10-14 months]
Basic Reading Skill
- Change in Score of Reading Fluency [10-14 months]
Reading Speed
- Change in Score of Calculation [10-14 months]
Math Calculation Skills
- Change in Score of Math Fluency [10-14 months]
Math Speed
- Change in Score of Word Attack [10-14 months]
Phoneme/Grapheme Knowledge
- Change in Score of Grooved Pegboard [10-14 months]
Bilateral Fine Motor Speed and Dexterity
- Change in Score of Trail Making Test, Part A and B [10-14 months]
Simple and complex Attention
- Change in Score of Conners Continuous Performance Test 3rd Edition [10-14 months]
Sustained Attention and Behavioral Inhibition
Secondary Outcome Measures
- Change in Examination of Optical Coherence Tomography [10-14 months]
Eye examination
- Change in PROMIS Mobility score [10-14 months]
Patient Reported Outcomes Measures: Mobility, walking
- Change in PROMIS Pain score [10-14 months]
Patient Reported Outcomes Measures: overall pain level
- Change in PROMIS Peer relationship score [10-14 months]
Patient Reported Outcomes Measures: Peer relationships
- Change in PROMIS Stress score [10-14 months]
Patient Reported Outcomes Measures: Psychological stress
- Change in PROMIS Upper extremity movement score [10-14 months]
Patient Reported Outcomes Measures: Upper extremity movement
- Change in score of 25 foot timed walk [10-14 months]
Walking speed
- Change in score of 6 minute timed walk [10-14 months]
Walking Distance
- Change in score of Hauser Ambulation Index [10-14 months]
Functional walking assessment
- Change in score of Multiple Sclerosis Functional Capacity (MSFC) [10-14 months]
Hand and Eye coordination, Memory test
- Change in score of Modified Rankin Scale [10-14 months]
Disability scale
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of Multiple Sclerosis , ADEM, anti-MOG antibody associated CNS demyelination
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Age 12 to 21 inclusive at time of enrollment
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Ability of parent or legal guardian to provide informed consent if participant is under 18.
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Ability of patients age 12-17 to give assent
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Completion of the signed HIPPA authorization form by a parent or legal guardian or by participants (18 years of age).
Exclusion Criteria:
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Known history of traumatic brain injury that required medical care
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Non-English speaking (based on standardized neuropsychological testing and questionnaires)
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Texas Southwestern | Dallas | Texas | United States | 75390 |
Sponsors and Collaborators
- University of Texas Southwestern Medical Center
Investigators
- Principal Investigator: Benjamin Greenberg, MD. MHS, University Texas Southwestern
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STU-2019-0491