CompletedNot Applicable

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

United States49 participantsStarted 2019-10-22

Plain-language 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.

Who can participate

Age range12 Years – 21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 18.
✓. 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

What they're measuring

MRI Brain without contrast

Timeframe: 10-14 months

MRI Brain without contrast

Timeframe: 10-14 months

Change in Score of Delis-Kaplan Executive Function System (D-KEFS) Color

Timeframe: 10-14 months

Change in Score of Word Interference Test (CWIT)

Timeframe: 10-14 months

Change in Score of Symbol Digit Modalities (SDMT)- Oral Version

Timeframe: 10-14 months

Change in Score of Beery-Buktencia Developmental Test of Visual-Motor Integration, Sixth Edition (VMI-6)

Timeframe: 10-14 months

Change in Score of Wechsler Intelligence Scale for Children-5th edition (WISCV)

Timeframe: 10-14 months

Change in Score of Wechsler Adult Intelligence Scale-Fourth edition (WAIS-IV) Digits Forward

Timeframe: 10-14 months

Trial details

NCT IDNCT03942952

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-06-30

View on ClinicalTrials.gov More Multiple Sclerosis, Relapsing-Remitting trials

Plain-language summary

Who can participate

Age range12 Years – 21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 18.
✓. 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

What they're measuring

MRI Brain without contrast

Timeframe: 10-14 months

MRI Brain without contrast

Timeframe: 10-14 months

Change in Score of Delis-Kaplan Executive Function System (D-KEFS) Color

Timeframe: 10-14 months

Change in Score of Word Interference Test (CWIT)

Timeframe: 10-14 months

Change in Score of Symbol Digit Modalities (SDMT)- Oral Version

Timeframe: 10-14 months

Change in Score of Beery-Buktencia Developmental Test of Visual-Motor Integration, Sixth Edition (VMI-6)

Timeframe: 10-14 months

Change in Score of Wechsler Intelligence Scale for Children-5th edition (WISCV)

Timeframe: 10-14 months

Change in Score of Wechsler Adult Intelligence Scale-Fourth edition (WAIS-IV) Digits Forward

Timeframe: 10-14 months