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CompletedNCT04565431Updated Aug 11, 2026

Examining Effects of Tysabri on Cognitive Fatigue Using fMRI

An observational study in Multiple Sclerosis, Relapsing-Remitting, sponsored by Kessler Foundation. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by Kessler Foundation · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
7
Ages
18 Years to 64 Years
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

  • Multiple Sclerosis, Relapsing-Remitting

Keywords

  • Multiple Sclerosis
  • Cognitive Fatigue
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In context

Multiple Sclerosis, Relapsing-Remitting

602 studies on the registry are indexed under Multiple Sclerosis, Relapsing-Remitting; 80 are open to participants now.

This study's enrollment of 7 is below the median of 116 across 151 observational studies indexed under Multiple Sclerosis, Relapsing-Remitting.

Browse Multiple Sclerosis, Relapsing-Remitting studies →

Lead sponsor

Kessler Foundation is the lead sponsor of 170 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Individuals diagnosed with Relapsing-Remitting Multiple Sclerosis and Healthy Volunteers

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

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
7 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Group 2: Healthy Controls

    Healthy individuals who are age, gender and education matched to the MS group.

Interventions

  • DrugTysabri

    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.

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What researchers measure

Primary outcomes

  1. 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).

    Time frame: Measured by change between 2 time points (baseline and six months after intervention)

Secondary outcomes

  1. 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)

    Time frame: Measured by change between 2 time points (baseline and six months after intervention)

  2. 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)

    Time frame: Measured by change between 2 time points (baseline and six months after intervention)

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Study locations

1 site
  • Kessler Foundation
    West Orange, New Jersey 07052, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04565431
Lead sponsor
Kessler Foundation
Collaborators
St. Barnabas Medical Center
Responsible party
John DeLuca (Sr. Vice President for Research, Kessler Foundation) — Principal investigator
First posted
Sep 25, 2020
Start date
Mar 19, 2021
Primary completion
Dec 15, 2025
Completion
Dec 15, 2025
Last update
Aug 11, 2026

Study contacts

John DeLuca, Ph.D.
principal investigator · Kessler Foundation

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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