An observational study in Multiple Sclerosis, Relapsing-Remitting, Neuromyelitis Optica and Acute Disseminated Encephalomyelitis, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 12 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-05.
Sponsored by University of Texas Southwestern Medical Center · Observational
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.
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.
618 studies on the registry are indexed under Multiple Sclerosis, Relapsing-Remitting; 82 are open to participants now.
This study's enrollment of 49 is below the median of 120 across 157 observational studies indexed under Multiple Sclerosis, Relapsing-Remitting.
Browse Multiple Sclerosis, Relapsing-Remitting studies →University of Texas Southwestern Medical Center is the lead sponsor of 1,010 studies on the registry; 199 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Teenagers before 22 at the time of consent diagnosis with a Central Nervous System demyelinating disorder.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnosis of CNS demyelinating disorder: Multiple Sclerosis, Transverse Myelitis, Neuromyelitis Optica, Acute Disseminated Encephalomyelitis, anti-MOG antibody, Optic Neuritis. * 3T and 7T MRI * Neuropsychological testing * Optical Coherence Tomography * Questionnaires: Quality of Life and Behavior scales * Non invasive clinical assessment : Walking, hand and eye coordination tests Repeat same research activities one to year and a half year later
* 3T and 7T MRI * Neuropsychological testing * Optical Coherence Tomography * Questionnaires: Quality of Life and Behavior scales * Non invasive clinical assessment : Walking, hand and eye coordination tests Repeat same research activities one year to a year and a half later
MRI Brain without contrast
3T MRI
Time frame: 10-14 months
MRI Brain without contrast
7T MRI
Time frame: 10-14 months
Change in Score of Delis-Kaplan Executive Function System (D-KEFS) Color
Executive Functioning
Time frame: 10-14 months
Change in Score of Word Interference Test (CWIT)
Executive Functioning
Time frame: 10-14 months
Change in Score of Symbol Digit Modalities (SDMT)- Oral Version
Processing Speed
Time frame: 10-14 months
Change in Score of Beery-Buktencia Developmental Test of Visual-Motor Integration, Sixth Edition (VMI-6)
Visual-Motor Integration
Time frame: 10-14 months
Change in Score of Wechsler Intelligence Scale for Children-5th edition (WISCV)
Simple Auditory Attention
Time frame: 10-14 months
Change in Score of Wechsler Adult Intelligence Scale-Fourth edition (WAIS-IV) Digits Forward
Simple Auditory Attention
Time frame: 10-14 months
Change in Score of WISC-V or WAIS-IV Digits Backward
Working Memory
Time frame: 10-14 months
Change in Score of California Verbal Learning Test- Children's Version (CVLT-C) or California Verbal Learning Test-Second Edition (CVLT-II)
Verbal Learning and Memory
Time frame: 10-14 months
Change i Score of D-KEFS Letter and Category Fluency
Verbal Fluency
Time frame: 10-14 months
Change in Score of WASI-II
Estimate of IQ
Time frame: 10-14 months
Change in Score of Woodcock-Johnson Tests of Achievement Letter Word identification
Basic Reading Skill
Time frame: 10-14 months
Change in Score of Reading Fluency
Reading Speed
Time frame: 10-14 months
Change in Score of Calculation
Math Calculation Skills
Time frame: 10-14 months
Change in Score of Math Fluency
Math Speed
Time frame: 10-14 months
Change in Score of Word Attack
Phoneme/Grapheme Knowledge
Time frame: 10-14 months
Change in Score of Grooved Pegboard
Bilateral Fine Motor Speed and Dexterity
Time frame: 10-14 months
Change in Score of Trail Making Test, Part A and B
Simple and complex Attention
Time frame: 10-14 months
Change in Score of Conners Continuous Performance Test 3rd Edition
Sustained Attention and Behavioral Inhibition
Time frame: 10-14 months
Change in Examination of Optical Coherence Tomography
Eye examination
Time frame: 10-14 months
Change in PROMIS Mobility score
Patient Reported Outcomes Measures: Mobility, walking
Time frame: 10-14 months
Change in PROMIS Pain score
Patient Reported Outcomes Measures: overall pain level
Time frame: 10-14 months
Change in PROMIS Peer relationship score
Patient Reported Outcomes Measures: Peer relationships
Time frame: 10-14 months
Change in PROMIS Stress score
Patient Reported Outcomes Measures: Psychological stress
Time frame: 10-14 months
Change in PROMIS Upper extremity movement score
Patient Reported Outcomes Measures: Upper extremity movement
Time frame: 10-14 months
Change in score of 25 foot timed walk
Walking speed
Time frame: 10-14 months
Change in score of 6 minute timed walk
Walking Distance
Time frame: 10-14 months
Change in score of Hauser Ambulation Index
Functional walking assessment
Time frame: 10-14 months
Change in score of Multiple Sclerosis Functional Capacity (MSFC)
Hand and Eye coordination, Memory test
Time frame: 10-14 months
Change in score of Modified Rankin Scale
Disability scale
Time frame: 10-14 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2019 to primary completion in Jun 2023, 44 months.
Of 41 non-industry observational studies under Multiple Sclerosis, Relapsing-Remitting, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 56. This study's 44 months is close to that.
Counting every sponsor, half of 67 studies reached it within 41 months; a quarter within 23 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Multiple Sclerosis, Relapsing-Remitting →
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