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

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

— SONICS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03942952
• Other study ID #: STU-2019-0491
• Status: Completed
• Start date: October 22, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2023
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Disseminated Encephalomyelitis
• Encephalomyelitis
• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Myelitis
• Myelitis, Transverse
• Neuromyelitis Optica
• Sclerosis
• Transverse Myelitis

Locations

Country	Name	City	State
United States	University Texas Southwestern	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI Brain without contrast	3T MRI	10-14 months
Primary	MRI Brain without contrast	7T MRI	10-14 months
Primary	Change in Score of Delis-Kaplan Executive Function System (D-KEFS) Color	Executive Functioning	10-14 months
Primary	Change in Score of Word Interference Test (CWIT)	Executive Functioning	10-14 months
Primary	Change in Score of Symbol Digit Modalities (SDMT)- Oral Version	Processing Speed	10-14 months
Primary	Change in Score of Beery-Buktencia Developmental Test of Visual-Motor Integration, Sixth Edition (VMI-6)	Visual-Motor Integration	10-14 months
Primary	Change in Score of Wechsler Intelligence Scale for Children-5th edition (WISCV)	Simple Auditory Attention	10-14 months
Primary	Change in Score of Wechsler Adult Intelligence Scale-Fourth edition (WAIS-IV) Digits Forward	Simple Auditory Attention	10-14 months
Primary	Change in Score of WISC-V or WAIS-IV Digits Backward	Working Memory	10-14 months
Primary	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	10-14 months
Primary	Change i Score of D-KEFS Letter and Category Fluency	Verbal Fluency	10-14 months
Primary	Change in Score of WASI-II	Estimate of IQ	10-14 months
Primary	Change in Score of Woodcock-Johnson Tests of Achievement Letter Word identification	Basic Reading Skill	10-14 months
Primary	Change in Score of Reading Fluency	Reading Speed	10-14 months
Primary	Change in Score of Calculation	Math Calculation Skills	10-14 months
Primary	Change in Score of Math Fluency	Math Speed	10-14 months
Primary	Change in Score of Word Attack	Phoneme/Grapheme Knowledge	10-14 months
Primary	Change in Score of Grooved Pegboard	Bilateral Fine Motor Speed and Dexterity	10-14 months
Primary	Change in Score of Trail Making Test, Part A and B	Simple and complex Attention	10-14 months
Primary	Change in Score of Conners Continuous Performance Test 3rd Edition	Sustained Attention and Behavioral Inhibition	10-14 months
Secondary	Change in Examination of Optical Coherence Tomography	Eye examination	10-14 months
Secondary	Change in PROMIS Mobility score	Patient Reported Outcomes Measures: Mobility, walking	10-14 months
Secondary	Change in PROMIS Pain score	Patient Reported Outcomes Measures: overall pain level	10-14 months
Secondary	Change in PROMIS Peer relationship score	Patient Reported Outcomes Measures: Peer relationships	10-14 months
Secondary	Change in PROMIS Stress score	Patient Reported Outcomes Measures: Psychological stress	10-14 months
Secondary	Change in PROMIS Upper extremity movement score	Patient Reported Outcomes Measures: Upper extremity movement	10-14 months
Secondary	Change in score of 25 foot timed walk	Walking speed	10-14 months
Secondary	Change in score of 6 minute timed walk	Walking Distance	10-14 months
Secondary	Change in score of Hauser Ambulation Index	Functional walking assessment	10-14 months
Secondary	Change in score of Multiple Sclerosis Functional Capacity (MSFC)	Hand and Eye coordination, Memory test	10-14 months
Secondary	Change in score of Modified Rankin Scale	Disability scale	10-14 months