NCT03066752

Completed

Cognitive Dysfunction in MS: Using Altered Brain Oscillation...

The Hospital for Sick Children Source

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Other study identifiers

Sponsor study identifier

1000054117

Study Type

observational

Actual enrollment (reported)

20

Locations

1 country

Sites

1

Timeline

Study Start

March 27, 2017

Actual (reported)

Primary Completion

November 24, 2017

Actual (reported)

Study Completion

November 24, 2017

Actual (reported)

Brief 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. 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 20 participants
Study completion date: November 24, 2017
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
January 3, 2017
Actual (reported)
First Posted
February 28, 2017
Actual (reported)
Study Start
March 27, 2017
Actual (reported)
Primary Completion
November 24, 2017
Actual (reported)
Study Completion
November 24, 2017
Actual (reported)

Last Updated: January 7, 2020
Status Verified: January 2020
Last Update Submitted: January 6, 2020

Conditions

Pediatric Multiple Sclerosis

Outcome Measures

Primary Outcomes (5)

Neuronal responses during simple and choice reaction time tasks
Video-based eye tracking in the MEG
60 minutes
MRI scans of the brain, including Diffusion Tensor Imagine (DTI)
90 minutes
Neurocognitive Testing
Penn Computerized Neurocognitive Battery
90 minutes
Neurological Exam - Standard physical exam performed by the neurologist to determine the Expanded Disability Status Scale (EDSS) score.
20 minutes
Clinical Interview
Series of questions about the participant's demographic and clinical information including, current and past health, family history, and medications.
10 minutes

Study Arms (2)

7 pediatric-onset multiple sclerosis

7 non-patient healthy volunteers

Eligibility Criteria

Age6 Years - 18 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64)

Sampling MethodNon-Probability Sample

Study Population

Seven patients who have pediatric-onset multiple sclerosis and 7 healthy (non-patient) children are expected to participate in this study.

You may qualify if:

Must be between 6 and 17 years and 11 months of age\*;

Sponsors & Collaborators

The Hospital for Sick Children
Otherlead

Study Sites (1)

Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Enrollment

20 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE CONTROL
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Associate Scientist, Research Institute

Study Record Dates

First Submitted

January 3, 2017

First Posted

February 28, 2017

Study Start

March 27, 2017

Actual (reported)

NCT01396343

Environmental and Genetic Risk Factors for Pediatric Multiple Sclerosis

Completed

NCT04660227

Exercise Training in Pediatric-Onset Multiple Sclerosis Patients

Not ApplicableCompleted

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).\*

You may not qualify if:

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.\*;
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.\*

Contact the study team to confirm eligibility.

Primary Completion

November 24, 2017

Actual (reported)

Study Completion

November 24, 2017

Actual (reported)

Last Updated

January 7, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing: Will not share

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT03066752
Data provider: ClinicalTrials.gov
Source updated: 2020-01-07
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:24:57 UTC

Locations

CA(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (5)

Study Arms (2)

7 pediatric-onset multiple sclerosis

7 non-patient healthy volunteers

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations