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 range

12 Years – 21 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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 range

12 Years – 21 Years

Sex

ALL

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

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