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Completed

NCT Number: NCT04565431

Examining Effects of Tysabri on Cognitive Fatigue Using fMRI

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.

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Key information

Conditions

Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kessler Foundation

West Orange, New Jersey, 07052, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tysabri

Drug

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.

Primary outcomes

  1. Brain activation (BOLD signal)

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

    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).

Secondary outcomes

  1. Fatigue onset (SDMT)

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

    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)

  2. Fatigue onset

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

    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)

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Collaborators

  • St. Barnabas Medical Center

Registry information

Official study title

Biomarker for Cognitive Fatigue Using Functional Imaging in Multiple Sclerosis

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Sep 25, 2020
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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