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Cognitive Dysfunction in MS: Using Altered Brain Oscillation to Link Molecular Mechanisms With Clinical Outcomes

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ClinicalTrials.gov Identifier: NCT03066752
Recruitment Status : Completed
First Posted : February 28, 2017
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
E. Ann Yeh, The Hospital for Sick Children

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.

Condition or disease
Pediatric Multiple Sclerosis

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Cognitive Dysfunction in MS: Using Altered Brain Oscillation to Link Molecular Mechanisms With Clinical Outcomes
Actual Study Start Date : March 27, 2017
Actual Primary Completion Date : November 24, 2017
Actual Study Completion Date : November 24, 2017

Resource links provided by the National Library of Medicine


Group/Cohort
7 pediatric-onset multiple sclerosis
7 non-patient healthy volunteers



Primary Outcome Measures :
  1. Neuronal responses during simple and choice reaction time tasks [ Time Frame: 60 minutes ]
    Video-based eye tracking in the MEG

  2. MRI scans of the brain, including Diffusion Tensor Imagine (DTI) [ Time Frame: 90 minutes ]
  3. Neurocognitive Testing [ Time Frame: 90 minutes ]
    Penn Computerized Neurocognitive Battery

  4. Neurological Exam - Standard physical exam performed by the neurologist to determine the Expanded Disability Status Scale (EDSS) score. [ Time Frame: 20 minutes ]
  5. 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.



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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.
Criteria

Inclusion Criteria (*applicable to controls):

  1. Must be between 6 and 17 years and 11 months of age*;
  2. Have a diagnosis of MS according to the revised McDonald diagnostic criteria and/or International Pediatric MS Study Group criteria;
  3. Has English language knowledge at the level needed to complete clinical questionnaires (4th grade level).*

Exclusion Criteria (*applicable to controls):

  1. Neurological comorbidity.*;
  2. Relapses or requires treatment with steroids within 30 days from enrollment;
  3. Is pregnant at the time of enrollment.*;
  4. Has any metal parts in their body (i.e. Cochlear (ear) implant, metal braces (dental fillings are o.k.).*;
  5. Is younger than 6 years of age.*;
  6. Is older than 18 years of age.*;
  7. Has prior history of traumatic brain injury, neurological disorder, cerebral palsy, developmental delay or learning disability.*;
  8. Requires sedation for brain scanning.*;
  9. Is claustrophobic, as brain scanning requires children to enter a tunnel in the MRI machine.*

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03066752


Locations
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Canada, Ontario
Hospital for Sick Children
Toronto, Ontario, Canada, M5G1X8
Sponsors and Collaborators
The Hospital for Sick Children

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Responsible Party: E. Ann Yeh, Associate Scientist, Research Institute, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT03066752     History of Changes
Other Study ID Numbers: 1000054117
First Posted: February 28, 2017    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Cognitive Dysfunction
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders