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

Pediatric Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03066752
• Other study ID #: 1000054117
• Status: Completed
• Start date: March 27, 2017
• Est. completion date: November 24, 2017

Study information

• Verified date: January 2020
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 24, 2017
• Est. primary completion date: November 24, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.*

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Multiple Sclerosis
• Pediatric Multiple Sclerosis

Locations

Country	Name	City	State
Canada	Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

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