Multiple Sclerosis, Relapsing-RemittingSONICSNCT03942952
PEDIATRIC SONICS: Pediatric Study of Neuropsychology and Imaging in CNS Demyelinating Syndromes.
An observational study of Multiple Sclerosis, Relapsing-Remitting and Neuromyelitis Optica, run by University of Texas Southwestern Medical Center at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 12 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting, Neuromyelitis Optica, Acute Disseminated Encephalomyelitis
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2019to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Teenagers before 22 at the time of consent diagnosis with a Central Nervous System demyelinating disorder.
Who may be able to join
- 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 18.
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting, Neuromyelitis Optica, Acute Disseminated Encephalomyelitis, Transverse Myelitis
- Keywords
- Multiple Sclerosis, NMO, anti-MOG, Acute Disseminated Encephalolmyelitis
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Neuromyelitis Optica, Encephalomyelitis, Acute Disseminated, Myelitis, Transverse, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI Brain without contrast
3T MRI
Measured: 10-14 months
MRI Brain without contrast
7T MRI
Measured: 10-14 months
Change in Score of Delis-Kaplan Executive Function System (D-KEFS) Color
Executive Functioning
Measured: 10-14 months
Change in Score of Word Interference Test (CWIT)
Executive Functioning
Measured: 10-14 months
Change in Score of Symbol Digit Modalities (SDMT)- Oral Version
Processing Speed
Measured: 10-14 months
Change in Score of Beery-Buktencia Developmental Test of Visual-Motor Integration, Sixth Edition (VMI-6)
Visual-Motor Integration
Measured: 10-14 months
Change in Score of Wechsler Intelligence Scale for Children-5th edition (WISCV)
Simple Auditory Attention
Measured: 10-14 months
Change in Score of Wechsler Adult Intelligence Scale-Fourth edition (WAIS-IV) Digits Forward
Simple Auditory Attention
Measured: 10-14 months
Change in Score of WISC-V or WAIS-IV Digits Backward
Working Memory
Measured: 10-14 months
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
Measured: 10-14 months
Change i Score of D-KEFS Letter and Category Fluency
Verbal Fluency
Measured: 10-14 months
Change in Score of WASI-II
Estimate of IQ
Measured: 10-14 months
Change in Score of Woodcock-Johnson Tests of Achievement Letter Word identification
Basic Reading Skill
Measured: 10-14 months
Change in Score of Reading Fluency
Reading Speed
Measured: 10-14 months
Change in Score of Calculation
Math Calculation Skills
Measured: 10-14 months
Change in Score of Math Fluency
Math Speed
Measured: 10-14 months
Change in Score of Word Attack
Phoneme/Grapheme Knowledge
Measured: 10-14 months
Change in Score of Grooved Pegboard
Bilateral Fine Motor Speed and Dexterity
Measured: 10-14 months
Change in Score of Trail Making Test, Part A and B
Simple and complex Attention
Measured: 10-14 months
Change in Score of Conners Continuous Performance Test 3rd Edition
Sustained Attention and Behavioral Inhibition
Measured: 10-14 months
Secondary outcomes (11)
Change in Examination of Optical Coherence Tomography
Eye examination
Measured: 10-14 months
Change in PROMIS Mobility score
Patient Reported Outcomes Measures: Mobility, walking
Measured: 10-14 months
Change in PROMIS Pain score
Patient Reported Outcomes Measures: overall pain level
Measured: 10-14 months
Change in PROMIS Peer relationship score
Patient Reported Outcomes Measures: Peer relationships
Measured: 10-14 months
Change in PROMIS Stress score
Patient Reported Outcomes Measures: Psychological stress
Measured: 10-14 months
Change in PROMIS Upper extremity movement score
Patient Reported Outcomes Measures: Upper extremity movement
Measured: 10-14 months
Change in score of 25 foot timed walk
Walking speed
Measured: 10-14 months
Change in score of 6 minute timed walk
Walking Distance
Measured: 10-14 months
Change in score of Hauser Ambulation Index
Functional walking assessment
Measured: 10-14 months
Change in score of Multiple Sclerosis Functional Capacity (MSFC)
Hand and Eye coordination, Memory test
Measured: 10-14 months
Change in score of Modified Rankin Scale
Disability scale
Measured: 10-14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start22 Oct 2019
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Greenberg, University of Texas Southwestern Medical Center
- Investigators
- Benjamin Greenberg, MD. MHS, Principal investigator, University Texas Southwestern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03942952
- Sponsor's protocol ID
- STU-2019-0491
- Acronym
- SONICS
- Status last verified
- Aug 2023
- First submitted
- 22 Apr 2019
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEDIATRIC SONICS: Pediatric Study of Neuropsychology and Imaging in CNS Demyelinating Syndromes.
- ClinicalTrials.gov ID
- NCT03942952
- Acronym / sponsor ID
- SONICS / STU-2019-0491
- Conditions
- Multiple Sclerosis, Relapsing-Remitting, Neuromyelitis Optica, Acute Disseminated Encephalomyelitis, Transverse Myelitis
- Keywords
- Multiple Sclerosis, NMO, anti-MOG, Acute Disseminated Encephalolmyelitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 8 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Teenagers before 22 at the time of consent diagnosis with a Central Nervous System demyelinating disorder.
Key inclusion criteria (5 listed)
- 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 18.
- 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).
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
11 secondary outcomes
Change in Examination of Optical Coherence Tomography
Time frame: 10-14 months
Change in PROMIS Mobility score
Time frame: 10-14 months
Change in PROMIS Pain score
Time frame: 10-14 months
Change in PROMIS Peer relationship score
Time frame: 10-14 months
Change in PROMIS Stress score
Time frame: 10-14 months
Change in PROMIS Upper extremity movement score
Time frame: 10-14 months
Change in score of 25 foot timed walk
Time frame: 10-14 months
Change in score of 6 minute timed walk
Time frame: 10-14 months
Change in score of Hauser Ambulation Index
Time frame: 10-14 months
Change in score of Multiple Sclerosis Functional Capacity (MSFC)
Time frame: 10-14 months
Change in score of Modified Rankin Scale
Time frame: 10-14 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Greenberg, MD. MHS principal investigator
University Texas Southwestern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, Relapsing-Remitting and Neuromyelitis Optica, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI Brain without contrast (time frame: 10-14 months). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.