Clinical trial NCT03942952: PEDIATRIC SONICS: Pediatric Study of Neuropsychology and Imaging in CNS Demyelinating Syndromes.
Official title: PEDIATRIC SONICS: Pediatric Study of Neuropsychology and Imaging in CNS Demyelinating Syndromes.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis, Relapsing-Remitting
Neuromyelitis Optica
Acute Disseminated Encephalomyelitis
Transverse Myelitis
Keywords: Multiple Sclerosis
NMO
anti-MOG
Acute Disseminated Encephalolmyelitis
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2019-05-08
Enrollment: 49
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Teenagers before 22 at the time of consent diagnosis with a Central Nervous System demyelinating disorder.

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.

Eligibility criteria: 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).

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

Primary outcomes:
measure: MRI Brain without contrast
timeFrame: 10-14 months
measure: MRI Brain without contrast
timeFrame: 10-14 months
measure: Change in Score of Delis-Kaplan Executive Function System (D-KEFS) Color
timeFrame: 10-14 months
measure: Change in Score of Word Interference Test (CWIT)
timeFrame: 10-14 months
measure: Change in Score of Symbol Digit Modalities (SDMT)- Oral Version
timeFrame: 10-14 months
measure: Change in Score of Beery-Buktencia Developmental Test of Visual-Motor Integration, Sixth Edition (VMI-6)
timeFrame: 10-14 months
measure: Change in Score of Wechsler Intelligence Scale for Children-5th edition (WISCV)
timeFrame: 10-14 months
measure: Change in Score of Wechsler Adult Intelligence Scale-Fourth edition (WAIS-IV) Digits Forward
timeFrame: 10-14 months
measure: Change in Score of WISC-V or WAIS-IV Digits Backward
timeFrame: 10-14 months
measure: Change in Score of California Verbal Learning Test- Children's Version (CVLT-C) or California Verbal Learning Test-Second Edition (CVLT-II)
timeFrame: 10-14 months
measure: Change i Score of D-KEFS Letter and Category Fluency
timeFrame: 10-14 months
measure: Change in Score of WASI-II
timeFrame: 10-14 months
measure: Change in Score of Woodcock-Johnson Tests of Achievement Letter Word identification
timeFrame: 10-14 months
measure: Change in Score of Reading Fluency
timeFrame: 10-14 months
measure: Change in Score of Calculation
timeFrame: 10-14 months
measure: Change in Score of Math Fluency
timeFrame: 10-14 months
measure: Change in Score of Word Attack
timeFrame: 10-14 months
measure: Change in Score of Grooved Pegboard
timeFrame: 10-14 months
measure: Change in Score of Trail Making Test, Part A and B
timeFrame: 10-14 months
measure: Change in Score of Conners Continuous Performance Test 3rd Edition
timeFrame: 10-14 months
Secondary outcomes:
measure: Change in Examination of Optical Coherence Tomography
timeFrame: 10-14 months
measure: Change in PROMIS Mobility score
timeFrame: 10-14 months
measure: Change in PROMIS Pain score
timeFrame: 10-14 months
measure: Change in PROMIS Peer relationship score
timeFrame: 10-14 months
measure: Change in PROMIS Stress score
timeFrame: 10-14 months
measure: Change in PROMIS Upper extremity movement score
timeFrame: 10-14 months
measure: Change in score of 25 foot timed walk
timeFrame: 10-14 months
measure: Change in score of 6 minute timed walk
timeFrame: 10-14 months
measure: Change in score of Hauser Ambulation Index
timeFrame: 10-14 months
measure: Change in score of Multiple Sclerosis Functional Capacity (MSFC)
timeFrame: 10-14 months
measure: Change in score of Modified Rankin Scale
timeFrame: 10-14 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University Texas Southwestern
state: Texas
Study officials:
affiliation: University Texas Southwestern
name: Benjamin Greenberg, MD. MHS
role: PRINCIPAL_INVESTIGATOR
References: