PEDIATRIC SONICS: Pediatric Study of Neuropsychology and Imaging in CNS Demyelinating Syndromes.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Sponsor
- University of Texas Southwestern Medical Center
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- Change i Score of D-KEFS Letter and Category Fluency
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
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.
Investigators
Benjamin Greenberg
Professor
University of Texas Southwestern Medical Center
Eligibility Criteria
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
- •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
Outcomes
Primary Outcomes
Change i Score of D-KEFS Letter and Category Fluency
Time Frame: 10-14 months
Verbal Fluency
Change in Score of Reading Fluency
Time Frame: 10-14 months
Reading Speed
Change in Score of Calculation
Time Frame: 10-14 months
Math Calculation Skills
MRI Brain without contrast
Time Frame: 10-14 months
7T MRI
Change in Score of Beery-Buktencia Developmental Test of Visual-Motor Integration, Sixth Edition (VMI-6)
Time Frame: 10-14 months
Visual-Motor Integration
Change in Score of Word Attack
Time Frame: 10-14 months
Phoneme/Grapheme Knowledge
Change in Score of WISC-V or WAIS-IV Digits Backward
Time Frame: 10-14 months
Working Memory
Change in Score of Woodcock-Johnson Tests of Achievement Letter Word identification
Time Frame: 10-14 months
Basic Reading Skill
Change in Score of Grooved Pegboard
Time Frame: 10-14 months
Bilateral Fine Motor Speed and Dexterity
Change in Score of Symbol Digit Modalities (SDMT)- Oral Version
Time Frame: 10-14 months
Processing Speed
Change in Score of Wechsler Adult Intelligence Scale-Fourth edition (WAIS-IV) Digits Forward
Time Frame: 10-14 months
Simple Auditory Attention
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
Change in Score of WASI-II
Time Frame: 10-14 months
Estimate of IQ
Change in Score of Conners Continuous Performance Test 3rd Edition
Time Frame: 10-14 months
Sustained Attention and Behavioral Inhibition
Change in Score of Delis-Kaplan Executive Function System (D-KEFS) Color
Time Frame: 10-14 months
Executive Functioning
Change in Score of Word Interference Test (CWIT)
Time Frame: 10-14 months
Executive Functioning
Change in Score of Wechsler Intelligence Scale for Children-5th edition (WISCV)
Time Frame: 10-14 months
Simple Auditory Attention
Change in Score of Trail Making Test, Part A and B
Time Frame: 10-14 months
Simple and complex Attention
Change in Score of Math Fluency
Time Frame: 10-14 months
Math Speed
Secondary Outcomes
- Change in score of Hauser Ambulation Index(10-14 months)
- Change in PROMIS Pain score(10-14 months)
- Change in score of Multiple Sclerosis Functional Capacity (MSFC)(10-14 months)
- Change in Examination of Optical Coherence Tomography(10-14 months)
- Change in PROMIS Upper extremity movement score(10-14 months)
- Change in score of 25 foot timed walk(10-14 months)
- Change in score of 6 minute timed walk(10-14 months)
- Change in PROMIS Mobility score(10-14 months)
- Change in PROMIS Peer relationship score(10-14 months)
- Change in PROMIS Stress score(10-14 months)
- Change in score of Modified Rankin Scale(10-14 months)