Examining Effects of Tysabri on Cognitive Fatigue Using fMRI

Biomarker for Cognitive Fatigue Using Functional Imaging in Multiple Sclerosis

The purpose of this research study is to investigate the effectiveness of Tysabri on cognitive fatigue in persons with Relapsing-Remitting Multiple Sclerosis (RRMS). Cognitive fatigue is the kind of fatigue that occurs after intense mental concentration as after a session of problem solving.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Intervention / Treatment: Drug: Tysabri

Detailed Description

The researchers aim is to investigate the effects of Tysabri on cognitive fatigue and on specific brain areas that have been shown to underlie cognitive fatigue in individuals with RRMS. The researchers will investigate the effects on the cognitive fatigue that develops during the performance of a demanding task and also on how cognitive fatigue changes as a function of duration of treatment.

• Study Type: Observational
• Enrollment (Estimated): 25

Contacts and Locations

• Study Contact: Name: Nancy Moore, M.A.; Phone Number: 19733248450; Email: nbmoore@kesslerfoundation.org
• Study Contact Backup: Name: Angela Smith, M.A.; Phone Number: 19733248448; Email: asmith@kesslerfoundation.org

Study Locations

• United States
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • Recruiting
      • Kessler Foundation
      • Principal Investigator: John DeLuca, PhD
      • Sub-Investigator: Helen Genova, PhD
      • Sub-Investigator: Glenn Wylie, PhD
      • Contact: Angela Smith, MA; Phone Number: 19733248448; Email: asmith@kesslerfoundation.org
      • Contact: Nancy Moore, MA; Phone Number: 973-324-8450; Email: nbmoore@kesslerfoundation.org
      • Sub-Investigator: Ekaterina Dobryakova, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Individuals diagnosed with Relapsing-Remitting Multiple Sclerosis and Healthy Volunteers

Description

Inclusion Criteria:

• Age between 18-64
• Diagnosed with Relapsing-Remitting Multiple Sclerosis or a healthy volunteer
• If diagnosed with MS: has been newly prescribed Tysabri, but has not yet started taking the medication
• Can read and speak English fluently

Exclusion Criteria:

• History of head injury, stroke, seizures, or any other significant neurological event other than MS
• Flare up of MS symptoms within the past month
• History of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder
• Pacemaker or other implanted electrical device, brain stimulator, aneurysm clip (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and internal hearing aids [cochlear implants]), permanent eyeliner, implanted delivery pumps, or shrapnel fragments
• Left-handed.
• Not able to have an MRI

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1: Multiple Sclerosis; Individuals with RRMS who are going to be starting Tysabri as determined by Neurologist as part of clinical care. Intervention: Drug: Tysabri	Drug: Tysabri; Participants with RRMS who are planning to begin treatment with Tysabri will be compared to a group of healthy individuals who are matched for age, gender, and education.
Group 2: Healthy Controls; Healthy individuals who are age, gender and education matched to the MS group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain activation (BOLD signal)	A change in brain activation as measured with functional magnetic resonance imaging through blood oxygen level dependent signal will be measured in association with cognitive fatigue (as measured by the Visual Analogue scale during performance of the modified Symbol Digit Modality Task and Modified Fatigue Impact Scale).	Measured by change between 2 time points (baseline and six months after intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue onset	A change in brain activation as measured with functional magnetic resonance imaging through blood oxygen level dependent signal will be measured in association with cognitive fatigue (as measured by the Modified Fatigue Impact Scale)	Measured by change between 2 time points (baseline and six months after intervention)
Fatigue onset (SDMT)	A change in the speed with which modified Symbol Digit Modality Task (a cognitively demanding task) induces fatigue in MS (as measured by the Visual Analogue scale)	Measured by change between 2 time points (baseline and six months after intervention)

Collaborators and Investigators

• Sponsor: Kessler Foundation
• Collaborators: St. Barnabas Medical Center
• Investigators: Principal Investigator: John DeLuca, Ph.D., Kessler Foundation

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 25, 2020
• First Submitted That Met QC Criteria: September 24, 2020
• First Posted (Actual): September 25, 2020

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Cognitive Fatigue
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Fatigue; Multiple Sclerosis, Relapsing-Remitting; Physiological Effects of Drugs; Immunologic Factors; Natalizumab
• Other Study ID Numbers: US-TYS-11640

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes