Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
116 participants
OBSERVATIONAL
2021-06-03
2025-06-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Pediatric MS Subjects
Subjects with pediatric MS will undergo fasting lab work, non-contrasted MRI, DEXA scan, and surveys.
No interventions assigned to this group
Healthy controls
Non-MS pediatric control subjects who will undergo fasting lab work, DEXA scan, and surveys for comparison to control group.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Relapsing-remitting MS diagnosis per 2017 McDonald criteria
* Ages ≥ 10 years to ≤ 20 years
* Diagnosis of MS or first clinical symptom of MS (whichever comes first) within ≤ 36 months from the time of enrollment.
* Ability to provide informed consent (or assent for minors)
* Age-, sex-, \& BMI-matched to pediatric MS subjects (1:1 allocation)
* Healthy children and young adults from the local communities
Exclusion Criteria
* Patients with an active, chronic disease of the immune system other than MS
* Conditions affecting the central nervous system (CNS) white matter (e.g. leukodystrophy) or for whom another condition may better explain imaging abnormalities (e.g. lupus)
* Myelin oligodendrocyte glycoprotein (MOG) antibodies on serologic testing
* Corticosteroid exposure within 30 days of study enrollment
* History of past imaging or neurologic event raising concern for any inflammatory CNS process
* Medical history or previous/current diagnosis consistent with an autoimmune disorder pertaining to any system of the body (e.g. diabetes mellitus type 1, Crohn's disease, lupus)
10 Years
20 Years
ALL
Yes
Sponsors
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Children's Hospital of Philadelphia
OTHER
University of Virginia
OTHER
Responsible Party
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J. Nicholas Brenton, MD
Assistant Professor of Neurology and Pediatrics
Principal Investigators
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J Nicholas Brenton, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Locations
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Virginia
Charlottesville, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Micky Bacchus
Role: primary
Rachael Coleman, MPH
Role: primary
References
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Brenton JN, Koenig S, Goldman MD. Vitamin D status and age of onset of demyelinating disease. Mult Scler Relat Disord. 2014 Nov;3(6):684-8. doi: 10.1016/j.msard.2014.07.004. Epub 2014 Jul 28.
Woolbright EB, Brenton JN. Attitudes toward obestity and diet modification in pediatric MS patients. Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS); February, 28 2020, 2019; West Palm Beach, FL.
Brenton JN, Woolbright E, Briscoe-Abath C, Qureshi A, Conaway M, Goldman MD. Body mass index trajectories in pediatric multiple sclerosis. Dev Med Child Neurol. 2019 Nov;61(11):1289-1294. doi: 10.1111/dmcn.14233. Epub 2019 Apr 5.
Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. doi: 10.1212/wnl.33.11.1444.
Centers for Disease Control. Healthy Weight. In. Vol 20162015
Disanto G, Barro C, Benkert P, Naegelin Y, Schadelin S, Giardiello A, Zecca C, Blennow K, Zetterberg H, Leppert D, Kappos L, Gobbi C, Kuhle J; Swiss Multiple Sclerosis Cohort Study Group. Serum Neurofilament light: A biomarker of neuronal damage in multiple sclerosis. Ann Neurol. 2017 Jun;81(6):857-870. doi: 10.1002/ana.24954.
Chitnis T, Gonzalez C, Healy BC, Saxena S, Rosso M, Barro C, Michalak Z, Paul A, Kivisakk P, Diaz-Cruz C, Sattarnezhad N, Pierre IV, Glanz BI, Tomic D, Kropshofer H, Haring D, Leppert D, Kappos L, Bakshi R, Weiner HL, Kuhle J. Neurofilament light chain serum levels correlate with 10-year MRI outcomes in multiple sclerosis. Ann Clin Transl Neurol. 2018 Oct 16;5(12):1478-1491. doi: 10.1002/acn3.638. eCollection 2018 Dec.
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Siller N, Kuhle J, Muthuraman M, Barro C, Uphaus T, Groppa S, Kappos L, Zipp F, Bittner S. Serum neurofilament light chain is a biomarker of acute and chronic neuronal damage in early multiple sclerosis. Mult Scler. 2019 Apr;25(5):678-686. doi: 10.1177/1352458518765666. Epub 2018 Mar 15.
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Valcarcel AM, Linn KA, Vandekar SN, Satterthwaite TD, Muschelli J, Calabresi PA, Pham DL, Martin ML, Shinohara RT. MIMoSA: An Automated Method for Intermodal Segmentation Analysis of Multiple Sclerosis Brain Lesions. J Neuroimaging. 2018 Jul;28(4):389-398. doi: 10.1111/jon.12506. Epub 2018 Mar 8.
Shinohara RT, Sweeney EM, Goldsmith J, Shiee N, Mateen FJ, Calabresi PA, Jarso S, Pham DL, Reich DS, Crainiceanu CM; Australian Imaging Biomarkers Lifestyle Flagship Study of Ageing; Alzheimer's Disease Neuroimaging Initiative. Statistical normalization techniques for magnetic resonance imaging. Neuroimage Clin. 2014 Aug 15;6:9-19. doi: 10.1016/j.nicl.2014.08.008. eCollection 2014.
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Kerbrat A, Aubert-Broche B, Fonov V, Narayanan S, Sled JG, Arnold DA, Banwell B, Collins DL. Reduced head and brain size for age and disproportionately smaller thalami in child-onset MS. Neurology. 2012 Jan 17;78(3):194-201. doi: 10.1212/WNL.0b013e318240799a. Epub 2012 Jan 4.
Brenton JN, Koshiya H, Engel CE, Herrod S, Engelhard M, Goldman MD. Utility of Physical Disability Outcome Measures in Pediatric-Onset Multiples Sclerosis. American Academy of Neurology. 2017.
Brenton JN, Koshiya H, Woolbright E, Goldman MD. The Multiple Sclerosis Functional Composite and Symbol Digit Modalities Test as outcome measures in pediatric multiple sclerosis. Mult Scler J Exp Transl Clin. 2019 Apr 29;5(2):2055217319846141. doi: 10.1177/2055217319846141. eCollection 2019 Apr-Jun.
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Other Identifiers
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HSR200257
Identifier Type: -
Identifier Source: org_study_id