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

Completed

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

• Registration Number: NCT03942952
• Lead Sponsor: 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), 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.

Study Timeline

• Study First Submitted: 2019-04-22
• Study First Submitted QC: 2019-05-07
• Study First Posted: 2019-05-08
• Study Start: 2019-10-22
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-31
• Last Update Posted: 2023-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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).

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Score of WISC-V or WAIS-IV Digits Backward	10-14 months	Working Memory
Change i Score of D-KEFS Letter and Category Fluency	10-14 months	Verbal Fluency
Change in Score of Reading Fluency	10-14 months	Reading Speed
Change in Score of Calculation	10-14 months	Math Calculation Skills
MRI Brain without contrast	10-14 months	7T MRI
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 Word Attack	10-14 months	Phoneme/Grapheme Knowledge
Change in Score of Woodcock-Johnson Tests of Achievement Letter Word identification	10-14 months	Basic Reading Skill
Change in Score of Grooved Pegboard	10-14 months	Bilateral Fine Motor Speed and Dexterity
Change in Score of Symbol Digit Modalities (SDMT)- Oral Version	10-14 months	Processing Speed
Change in Score of Wechsler Adult Intelligence Scale-Fourth edition (WAIS-IV) Digits Forward	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)	10-14 months	Verbal Learning and Memory
Change in Score of WASI-II	10-14 months	Estimate of IQ
Change in Score of Conners Continuous Performance Test 3rd Edition	10-14 months	Sustained Attention and Behavioral Inhibition
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 Wechsler Intelligence Scale for Children-5th edition (WISCV)	10-14 months	Simple Auditory Attention
Change in Score of Trail Making Test, Part A and B	10-14 months	Simple and complex Attention
Change in Score of Math Fluency	10-14 months	Math Speed

Secondary Outcome Measures

Name	Time	Method
Change in score of Hauser Ambulation Index	10-14 months	Functional walking assessment
Change in PROMIS Pain score	10-14 months	Patient Reported Outcomes Measures: overall pain level
Change in score of Multiple Sclerosis Functional Capacity (MSFC)	10-14 months	Hand and Eye coordination, Memory test
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 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 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 score of Modified Rankin Scale	10-14 months	Disability scale

Trial Locations

Locations (1)

University Texas Southwestern; 🇺🇸 Dallas, Texas, United States