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Examining Effects of Tysabri on Cognitive Fatigue Using fMRI

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ClinicalTrials.gov Identifier: NCT04565431
Recruitment Status : Recruiting
First Posted : September 25, 2020
Last Update Posted : July 28, 2021
Sponsor:
Collaborator:
St. Barnabas Medical Center
Information provided by (Responsible Party):
Kessler Foundation

Brief 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.

Condition or disease Intervention/treatment
Multiple Sclerosis, Relapsing-Remitting 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.

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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Biomarker for Cognitive Fatigue Using Functional Imaging in Multiple Sclerosis
Actual Study Start Date : March 19, 2021
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Natalizumab

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.



Primary Outcome Measures :
  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 Outcome Measures :
  1. Fatigue onset [ 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)



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Individuals diagnosed with Relapsing-Remitting Multiple Sclerosis and Healthy Volunteers
Criteria

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

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): NCT04565431


Contacts
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Contact: Nancy Moore, M.A. 19733248450 nbmoore@kesslerfoundation.org
Contact: Angela Smith, M.A. 19733248448 asmith@kesslerfoundation.org

Locations
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United States, New Jersey
Kessler Foundation Recruiting
West Orange, New Jersey, United States, 07052
Contact: Nancy Moore, MA    973-324-8450    nbmoore@kesslerfoundation.org   
Contact: Angela Smith, MA    19733248448    asmith@kesslerfoundation.org   
Principal Investigator: John DeLuca, PhD         
Sub-Investigator: Ekaterina Dobryakova, PhD         
Sub-Investigator: Helen Genova, PhD         
Sub-Investigator: Glenn Wylie, PhD         
Sponsors and Collaborators
Kessler Foundation
St. Barnabas Medical Center
Investigators
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Principal Investigator: John DeLuca, Ph.D. Kessler Foundation
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Responsible Party: Kessler Foundation
ClinicalTrials.gov Identifier: NCT04565431    
Other Study ID Numbers: US-TYS-11640
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021

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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
Keywords provided by Kessler Foundation:
Multiple Sclerosis
Cognitive Fatigue
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Fatigue
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Natalizumab
Immunologic Factors
Physiological Effects of Drugs