Pediatric Multiple SclerosisNCT03066752
Cognitive Dysfunction in MS: Using Altered Brain Oscillation to Link Molecular Mechanisms With Clinical Outcomes
An observational study of Pediatric Multiple Sclerosis, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Up to 65% of patients with multiple sclerosis (MS) experience cognitive dysfunction. Diminution of mental capacity has a pervasive and profound impact on their quality of life. Subtle changes in white matter predict cognitive changes in these patients but how this disrupts brain function remains unclear. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Multiple Sclerosis
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 27 Mar 2017to 24 Nov 2017
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Seven patients who have pediatric-onset multiple sclerosis and 7 healthy (non-patient) children are expected to participate in this study.
Who may be able to join
- Must be between 6 and 17 years and 11 months of age*;
- Have a diagnosis of MS according to the revised McDonald diagnostic criteria and/or International Pediatric MS Study Group criteria;
- Has English language knowledge at the level needed to complete clinical questionnaires (4th grade level).*
Who cannot join
- Neurological comorbidity.*;
- Relapses or requires treatment with steroids within 30 days from enrollment;
- Is pregnant at the time of enrollment.*;
- Has any metal parts in their body (i.e. Cochlear (ear) implant, metal braces (dental fillings are o.k.).*;
- Is younger than 6 years of age.*;
- Is older than 18 years of age.*;
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- Has prior history of traumatic brain injury, neurological disorder, cerebral palsy, developmental delay or learning disability.*;
- Requires sedation for brain scanning.*;
- Is claustrophobic, as brain scanning requires children to enter a tunnel in the MRI machine.*
Trial locations and contacts
1 site in 1 country.
About this study
Up to 65% of patients with multiple sclerosis (MS) experience cognitive dysfunction. Diminution of mental capacity has a pervasive and profound impact on their quality of life. Subtle changes in white matter predict cognitive changes in these patients but how this disrupts brain function remains unclear. Development of effective therapeutics to restore normal cognition hinges on elucidating these functional changes. The investigators seek to uncover the patho-physiological basis for cognitive decline in MS. The investigators hypothesize that cognitive decline originates from disrupted gamma oscillations and that gamma oscillations are disrupted by molecular changes triggered by demyelination.
- Conditions
- Pediatric 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 |
|---|---|---|
| 7 pediatric-onset multiple sclerosis | Not described | |
| 7 non-patient healthy volunteers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuronal responses during simple and choice reaction time tasks
Video-based eye tracking in the MEG
Measured: 60 minutes
MRI scans of the brain, including Diffusion Tensor Imagine (DTI)
Measured: 90 minutes
Neurocognitive Testing
Penn Computerized Neurocognitive Battery
Measured: 90 minutes
Neurological Exam - Standard physical exam performed by the neurologist to determine the Expanded Disability Status Scale (EDSS) score.
Measured: 20 minutes
Clinical Interview
Series of questions about the participant's demographic and clinical information including, current and past health, family history, and medications.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start27 Mar 2017
- Primary completion24 Nov 2017
- Study completion24 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, E. Ann Yeh, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03066752
- Sponsor's protocol ID
- 1000054117
- Status last verified
- Jan 2020
- First submitted
- 3 Jan 2017
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Dysfunction in MS: Using Altered Brain Oscillation to Link Molecular Mechanisms With Clinical Outcomes
- ClinicalTrials.gov ID
- NCT03066752
- Acronym / sponsor ID
- 1000054117
- Conditions
- Pediatric Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 24 Nov 2017 (actual)
- Study completion
- 24 Nov 2017 (actual)
- First posted
- 28 Feb 2017 (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.
Up to 65% of patients with multiple sclerosis (MS) experience cognitive dysfunction. Diminution of mental capacity has a pervasive and profound impact on their quality of life. Subtle changes in white matter predict cognitive changes in these patients but how this disrupts brain function remains unclear. Development of effective therapeutics to restore normal cognition hinges on elucidating these functional changes. The investigators seek to uncover the patho-physiological basis for cognitive decline in MS. The investigators hypothesize that cognitive decline originates from disrupted gamma oscillations and that gamma oscillations are disrupted by molecular changes triggered by demyelination.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 7 pediatric-onset multiple sclerosis | – | – |
| 7 non-patient healthy volunteers | – | – |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Seven patients who have pediatric-onset multiple sclerosis and 7 healthy (non-patient) children are expected to participate in this study.
Key inclusion criteria (3 listed)
- Must be between 6 and 17 years and 11 months of age*;
- Have a diagnosis of MS according to the revised McDonald diagnostic criteria and/or International Pediatric MS Study Group criteria;
- Has English language knowledge at the level needed to complete clinical questionnaires (4th grade level).*
Key exclusion criteria (9 listed)
- Neurological comorbidity.*;
- Relapses or requires treatment with steroids within 30 days from enrollment;
- Is pregnant at the time of enrollment.*;
- Has any metal parts in their body (i.e. Cochlear (ear) implant, metal braces (dental fillings are o.k.).*;
- Is younger than 6 years of age.*;
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
Neuronal responses during simple and choice reaction time tasks
Time frame: 60 minutes
Video-based eye tracking in the MEG
MRI scans of the brain, including Diffusion Tensor Imagine (DTI)
Time frame: 90 minutes
Neurocognitive Testing
Time frame: 90 minutes
Penn Computerized Neurocognitive Battery
Neurological Exam - Standard physical exam performed by the neurologist to determine the Expanded Disability Status Scale (EDSS) score.
Time frame: 20 minutes
Clinical Interview
Time frame: 10 minutes
Series of questions about the participant's demographic and clinical information including, current and past health, family history, and medications.
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 7 Jan 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pediatric Multiple Sclerosis, run by The Hospital for Sick Children at 1 site in Canada.
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 3 inclusion and 9 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 7 Jan 2020. 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 Canada. 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?
Neuronal responses during simple and choice reaction time tasks (time frame: 60 minutes). The study lists 5 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 7 Jan 2020; AzTrials last refreshed its copy on 28 Oct 2026.