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

• ClinicalTrials.gov Identifier: NCT03942952
• Recruitment Status: Active, not recruiting
• First Posted: May 8, 2019
• Last Update Posted: December 15, 2022
• Sponsor: University of Texas Southwestern Medical Center
• Information provided by (Responsible Party): Benjamin Greenberg, University of Texas Southwestern Medical Center

Study Description

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.

Condition or disease
Multiple Sclerosis, Relapsing-Remitting; Neuromyelitis Optica; Acute Disseminated Encephalomyelitis; Transverse Myelitis

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 160 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: PEDIATRIC SONICS: Pediatric Study of Neuropsychology and Imaging in CNS Demyelinating Syndromes.
• Actual Study Start Date: October 22, 2019
• Estimated Primary Completion Date: May 31, 2023
• Estimated Study Completion Date: May 31, 2024

Groups and Cohorts

Group/Cohort
CNS demyelinating diagnosis; 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
Healthy Control; 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

Outcome Measures

Primary Outcome Measures :

1. MRI Brain without contrast [ Time Frame: 10-14 months ]
   3T MRI
2. MRI Brain without contrast [ Time Frame: 10-14 months ]
   7T MRI
3. Change in Score of Delis-Kaplan Executive Function System (D-KEFS) Color [ Time Frame: 10-14 months ]
   Executive Functioning
4. Change in Score of Word Interference Test (CWIT) [ Time Frame: 10-14 months ]
   Executive Functioning
5. Change in Score of Symbol Digit Modalities (SDMT)- Oral Version [ Time Frame: 10-14 months ]
   Processing Speed
6. Change in Score of Beery-Buktencia Developmental Test of Visual-Motor Integration, Sixth Edition (VMI-6) [ Time Frame: 10-14 months ]
   Visual-Motor Integration
7. Change in Score of Wechsler Intelligence Scale for Children-5th edition (WISCV) [ Time Frame: 10-14 months ]
   Simple Auditory Attention
8. Change in Score of Wechsler Adult Intelligence Scale-Fourth edition (WAIS-IV) Digits Forward [ Time Frame: 10-14 months ]
   Simple Auditory Attention
9. Change in Score of WISC-V or WAIS-IV Digits Backward [ Time Frame: 10-14 months ]
   Working Memory
10. Change in Score of California Verbal Learning Test- Children's Version (CVLT-C) or California Verbal Learning Test-Second Edition (CVLT-II) [ Time Frame: 10-14 months ]
    Verbal Learning and Memory
11. Change i Score of D-KEFS Letter and Category Fluency [ Time Frame: 10-14 months ]
    Verbal Fluency
12. Change in Score of WASI-II [ Time Frame: 10-14 months ]
    Estimate of IQ
13. Change in Score of Woodcock-Johnson Tests of Achievement Letter Word identification [ Time Frame: 10-14 months ]
    Basic Reading Skill
14. Change in Score of Reading Fluency [ Time Frame: 10-14 months ]
    Reading Speed
15. Change in Score of Calculation [ Time Frame: 10-14 months ]
    Math Calculation Skills
16. Change in Score of Math Fluency [ Time Frame: 10-14 months ]
    Math Speed
17. Change in Score of Word Attack [ Time Frame: 10-14 months ]
    Phoneme/Grapheme Knowledge
18. Change in Score of Grooved Pegboard [ Time Frame: 10-14 months ]
    Bilateral Fine Motor Speed and Dexterity
19. Change in Score of Trail Making Test, Part A and B [ Time Frame: 10-14 months ]
    Simple and complex Attention
20. Change in Score of Conners Continuous Performance Test 3rd Edition [ Time Frame: 10-14 months ]
    Sustained Attention and Behavioral Inhibition

Secondary Outcome Measures :

1. Change in Examination of Optical Coherence Tomography [ Time Frame: 10-14 months ]
   Eye examination
2. Change in PROMIS Mobility score [ Time Frame: 10-14 months ]
   Patient Reported Outcomes Measures: Mobility, walking
3. Change in PROMIS Pain score [ Time Frame: 10-14 months ]
   Patient Reported Outcomes Measures: overall pain level
4. Change in PROMIS Peer relationship score [ Time Frame: 10-14 months ]
   Patient Reported Outcomes Measures: Peer relationships
5. Change in PROMIS Stress score [ Time Frame: 10-14 months ]
   Patient Reported Outcomes Measures: Psychological stress
6. Change in PROMIS Upper extremity movement score [ Time Frame: 10-14 months ]
   Patient Reported Outcomes Measures: Upper extremity movement
7. Change in score of 25 foot timed walk [ Time Frame: 10-14 months ]
   Walking speed
8. Change in score of 6 minute timed walk [ Time Frame: 10-14 months ]
   Walking Distance
9. Change in score of Hauser Ambulation Index [ Time Frame: 10-14 months ]
   Functional walking assessment
10. Change in score of Multiple Sclerosis Functional Capacity (MSFC) [ Time Frame: 10-14 months ]
    Hand and Eye coordination, Memory test
11. Change in score of Modified Rankin Scale [ Time Frame: 10-14 months ]
    Disability scale

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 21 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Teenagers before 22 at the time of consent diagnosis with a Central Nervous System demyelinating disorder.

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

Contacts and Locations

Locations

United States, Texas

University Texas Southwestern

Dallas, Texas, United States, 75390

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Investigators

• Principal Investigator: Benjamin Greenberg, MD. MHS; University Texas Southwestern

More Information

• Responsible Party: Benjamin Greenberg, Professor, University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT03942952
• Other Study ID Numbers: STU-2019-0491
• First Posted: May 8, 2019
• Last Update Posted: December 15, 2022
• Last Verified: December 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Benjamin Greenberg, University of Texas Southwestern Medical Center:

Multiple Sclerosis; NMO; anti-MOG; Acute Disseminated Encephalolmyelitis

Additional relevant MeSH terms:

Encephalomyelitis; Myelitis; Myelitis, Transverse; Multiple Sclerosis; Neuromyelitis Optica; Multiple Sclerosis, Relapsing-Remitting; Encephalomyelitis, Acute Disseminated; Sclerosis; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Eye Diseases; Central Nervous System Infections; Infections; Central Nervous System Diseases; Spinal Cord Diseases; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Neurodegenerative Diseases; Leukoencephalopathies