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出境医 / 临床实验 / PEDIATRIC SONICS: Pediatric Study of Neuropsychology and Imaging in CNS Demyelinating Syndromes. (SONICS)

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

Study Description
Brief Summary:
Central Nervous System (CNS) demyelinating conditions include multiple sclerosis (MS), Acute Disseminated Encephalomyelitis (ADEM), Neuromyelitis Optica Spectrum Disorder (NMOSD) 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 18 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 +/- 2 months. Each study visit will have the same neuropsychological, OCT, and research MRI examinations.
Study Design
Layout table for study information
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
Arms and Interventions
Group/Cohort
CNS demyelinating diagnosis

Diagnosis of CNS demyelinating disorder: Multiple Sclerosis, Transverse Myelitis, Neuromyelitis Optica, Acute Disseminated Encephalomyelitis, anti-MOG antibody.

  • 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 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 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
Layout table for eligibility information
Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Teenagers before 18 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 18 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 and older 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, pregnant, 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

Contacts
Layout table for location contacts
Contact: Tricia Plumb, RN, MSN 214-456-2464 patricia.plumb@utsouthwestern.edu

Locations
Layout table for location information
United States, Texas
University Texas Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Tricia Plumb, RN, MSN    214-456-2464    patricia.plumb@utsouthwestern.edu   
Principal Investigator: Benjamin Greenberg, MD, MHS         
Sub-Investigator: Lana Harder, PhD, ABPP         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Benjamin Greenberg, MD. MHS University Texas Southwestern
Tracking Information
First Submitted Date April 22, 2019
First Posted Date May 8, 2019
Last Update Posted Date November 5, 2020
Actual Study Start Date October 22, 2019
Estimated Primary Completion Date May 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 7, 2019)
  • MRI Brain without contrast [ Time Frame: 10-14 months ]
    3T MRI
  • MRI Brain without contrast [ Time Frame: 10-14 months ]
    7T MRI
  • Change in Score of Delis-Kaplan Executive Function System (D-KEFS) Color [ Time Frame: 10-14 months ]
    Executive Functioning
  • Change in Score of Word Interference Test (CWIT) [ Time Frame: 10-14 months ]
    Executive Functioning
  • Change in Score of Symbol Digit Modalities (SDMT)- Oral Version [ Time Frame: 10-14 months ]
    Processing Speed
  • Change in Score of Beery-Buktencia Developmental Test of Visual-Motor Integration, Sixth Edition (VMI-6) [ Time Frame: 10-14 months ]
    Visual-Motor Integration
  • Change in Score of Wechsler Intelligence Scale for Children-5th edition (WISCV) [ Time Frame: 10-14 months ]
    Simple Auditory Attention
  • Change in Score of Wechsler Adult Intelligence Scale-Fourth edition (WAIS-IV) Digits Forward [ Time Frame: 10-14 months ]
    Simple Auditory Attention
  • Change in Score of WISC-V or WAIS-IV Digits Backward [ Time Frame: 10-14 months ]
    Working Memory
  • 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
  • Change i Score of D-KEFS Letter and Category Fluency [ Time Frame: 10-14 months ]
    Verbal Fluency
  • Change in Score of WASI-II [ Time Frame: 10-14 months ]
    Estimate of IQ
  • Change in Score of Woodcock-Johnson Tests of Achievement Letter Word identification [ Time Frame: 10-14 months ]
    Basic Reading Skill
  • Change in Score of Reading Fluency [ Time Frame: 10-14 months ]
    Reading Speed
  • Change in Score of Calculation [ Time Frame: 10-14 months ]
    Math Calculation Skills
  • Change in Score of Math Fluency [ Time Frame: 10-14 months ]
    Math Speed
  • Change in Score of Word Attack [ Time Frame: 10-14 months ]
    Phoneme/Grapheme Knowledge
  • Change in Score of Grooved Pegboard [ Time Frame: 10-14 months ]
    Bilateral Fine Motor Speed and Dexterity
  • Change in Score of Trail Making Test, Part A and B [ Time Frame: 10-14 months ]
    Simple and complex Attention
  • Change in Score of Conners Continuous Performance Test 3rd Edition [ Time Frame: 10-14 months ]
    Sustained Attention and Behavioral Inhibition
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 7, 2019)
  • Change in Examination of Optical Coherence Tomography [ Time Frame: 10-14 months ]
    Eye examination
  • Change in PROMIS Mobility score [ Time Frame: 10-14 months ]
    Patient Reported Outcomes Measures: Mobility, walking
  • Change in PROMIS Pain score [ Time Frame: 10-14 months ]
    Patient Reported Outcomes Measures: overall pain level
  • Change in PROMIS Peer relationship score [ Time Frame: 10-14 months ]
    Patient Reported Outcomes Measures: Peer relationships
  • Change in PROMIS Stress score [ Time Frame: 10-14 months ]
    Patient Reported Outcomes Measures: Psychological stress
  • Change in PROMIS Upper extremity movement score [ Time Frame: 10-14 months ]
    Patient Reported Outcomes Measures: Upper extremity movement
  • Change in score of 25 foot timed walk [ Time Frame: 10-14 months ]
    Walking speed
  • Change in score of 6 minute timed walk [ Time Frame: 10-14 months ]
    Walking Distance
  • Change in score of Hauser Ambulation Index [ Time Frame: 10-14 months ]
    Functional walking assessment
  • Change in score of Multiple Sclerosis Functional Capacity (MSFC) [ Time Frame: 10-14 months ]
    Hand and Eye coordination, Memory test
  • Change in score of Modified Rankin Scale [ Time Frame: 10-14 months ]
    Disability scale
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title PEDIATRIC SONICS: Pediatric Study of Neuropsychology and Imaging in CNS Demyelinating Syndromes.
Official Title PEDIATRIC SONICS: Pediatric Study of Neuropsychology and Imaging in CNS Demyelinating Syndromes.
Brief Summary Central Nervous System (CNS) demyelinating conditions include multiple sclerosis (MS), Acute Disseminated Encephalomyelitis (ADEM), Neuromyelitis Optica Spectrum Disorder (NMOSD) 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.
Detailed Description Pediatric patients (age 12 to 18 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 +/- 2 months. Each study visit will have the same neuropsychological, OCT, and research MRI examinations.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Teenagers before 18 at the time of consent diagnosis with a Central Nervous System demyelinating disorder.
Condition
  • Multiple Sclerosis, Relapsing-Remitting
  • Neuromyelitis Optica
  • Acute Disseminated Encephalomyelitis
  • Transverse Myelitis
Intervention Not Provided
Study Groups/Cohorts
  • CNS demyelinating diagnosis

    Diagnosis of CNS demyelinating disorder: Multiple Sclerosis, Transverse Myelitis, Neuromyelitis Optica, Acute Disseminated Encephalomyelitis, anti-MOG antibody.

    • 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 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 later
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 7, 2019) 		160
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 31, 2024
Estimated Primary Completion Date May 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Diagnosis of Multiple Sclerosis , ADEM, anti-MOG antibody associated CNS demyelination
  2. Age 12 to 18 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 and older 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, pregnant, the presence of metallic braces, implants or medical devices that are unsafe at 3T or 7T and/or interfere with the MRI/MRS signals
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Tricia Plumb, RN, MSN 214-456-2464 patricia.plumb@utsouthwestern.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03942952
Other Study ID Numbers STU-2019-0491
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Benjamin Greenberg, University of Texas Southwestern Medical Center
Study Sponsor University of Texas Southwestern Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Benjamin Greenberg, MD. MHS University Texas Southwestern
PRS Account University of Texas Southwestern Medical Center
Verification Date November 2020

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