PEDIATRIC SONICS: Pediatric Study of Neuropsychology and Imaging in CNS Demyelinating Syndromes.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Change i Score of D-KEFS Letter and Category Fluency
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •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).
排除标准
- •Known history of traumatic brain injury that required medical care
- •Non-English speaking (based on standardized neuropsychological testing and questionnaires)
- •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
结局指标
主要结局
Change i Score of D-KEFS Letter and Category Fluency
时间窗: 10-14 months
Verbal Fluency
Change in Score of Reading Fluency
时间窗: 10-14 months
Reading Speed
Change in Score of Calculation
时间窗: 10-14 months
Math Calculation Skills
MRI Brain without contrast
时间窗: 10-14 months
7T MRI
Change in Score of Beery-Buktencia Developmental Test of Visual-Motor Integration, Sixth Edition (VMI-6)
时间窗: 10-14 months
Visual-Motor Integration
Change in Score of Word Attack
时间窗: 10-14 months
Phoneme/Grapheme Knowledge
Change in Score of WISC-V or WAIS-IV Digits Backward
时间窗: 10-14 months
Working Memory
Change in Score of Woodcock-Johnson Tests of Achievement Letter Word identification
时间窗: 10-14 months
Basic Reading Skill
Change in Score of Grooved Pegboard
时间窗: 10-14 months
Bilateral Fine Motor Speed and Dexterity
Change in Score of Symbol Digit Modalities (SDMT)- Oral Version
时间窗: 10-14 months
Processing Speed
Change in Score of Wechsler Adult Intelligence Scale-Fourth edition (WAIS-IV) Digits Forward
时间窗: 10-14 months
Simple Auditory Attention
Change in Score of California Verbal Learning Test- Children's Version (CVLT-C) or California Verbal Learning Test-Second Edition (CVLT-II)
时间窗: 10-14 months
Verbal Learning and Memory
Change in Score of WASI-II
时间窗: 10-14 months
Estimate of IQ
Change in Score of Conners Continuous Performance Test 3rd Edition
时间窗: 10-14 months
Sustained Attention and Behavioral Inhibition
Change in Score of Delis-Kaplan Executive Function System (D-KEFS) Color
时间窗: 10-14 months
Executive Functioning
Change in Score of Word Interference Test (CWIT)
时间窗: 10-14 months
Executive Functioning
Change in Score of Wechsler Intelligence Scale for Children-5th edition (WISCV)
时间窗: 10-14 months
Simple Auditory Attention
Change in Score of Trail Making Test, Part A and B
时间窗: 10-14 months
Simple and complex Attention
Change in Score of Math Fluency
时间窗: 10-14 months
Math Speed
次要结局
- Change in score of Hauser Ambulation Index(10-14 months)
- Change in PROMIS Pain score(10-14 months)
- Change in score of Multiple Sclerosis Functional Capacity (MSFC)(10-14 months)
- Change in Examination of Optical Coherence Tomography(10-14 months)
- Change in PROMIS Upper extremity movement score(10-14 months)
- Change in score of 25 foot timed walk(10-14 months)
- Change in score of 6 minute timed walk(10-14 months)
- Change in PROMIS Mobility score(10-14 months)
- Change in PROMIS Peer relationship score(10-14 months)
- Change in PROMIS Stress score(10-14 months)
- Change in score of Modified Rankin Scale(10-14 months)
研究者
Benjamin Greenberg
Professor
University of Texas Southwestern Medical Center