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Examining Effects of Ocrevus on Cognitive Fatigue Using fMRI

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ClinicalTrials.gov Identifier: NCT04448977
Recruitment Status : Recruiting
First Posted : June 26, 2020
Last Update Posted : July 23, 2021
Sponsor:
Collaborator:
Hackensack Meridian Health
Information provided by (Responsible Party):
Kessler Foundation

Brief Summary:
The purpose of this research study is to investigate the effectiveness of MS Disease modifying medications 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: Ocrevus

Detailed Description:
The researchers aim is to investigate the effects of disease modifying treatments on cognitive fatigue and on specific brain areas that have been shown to underlie cognitive fatigue in individuals with Multiple Sclerosis (MS). 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 : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Biomarker for Cognitive Fatigue Using Functional Imaging in MS
Actual Study Start Date : May 6, 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: Ocrelizumab

Group/Cohort Intervention/treatment
Multiple Sclerosis group 1
Individuals with Multiple Sclerosis who are going to be starting Ocrevus as determined by Neurologist as part of clinical care.
Drug: Ocrevus
Participants with MS will be divided into two treatment groups: those who will begin to take Ocrevus (the "early Ocrevus" group (EO), and those who plan to be begin treatment with Glatimer acetate SC (Copaxone) (EC). Both groups will be matched to the EO group for age, gender and education. The HC group will be free of neurological disease or injury and will be matched to the EO group for age, gender, and education.

Multiple Sclerosis group 2
Individuals with Multiple Sclerosis who are going to be starting Copaxone as determined by Neurologist as part of clinical care.
Healthy Controls
Healthy individuals who are age, gender and education matched to the other groups.



Primary Outcome Measures :
  1. Brain activation (BOLD signal) [ Time Frame: Measured for change at 3 time points (before, six months and 12 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 and Modified Fatigue Impact Scale).


Secondary Outcome Measures :
  1. Fatigue onset [ Time Frame: Measured for change at 3 time points for change (before, six months and 12 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 and 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 who have Relapsing remitting Multiple Sclerosis and Healthy Volunteers
Criteria

Inclusion Criteria:

  • Age between 18-64.
  • Relapsing remitting multiple sclerosis
  • Been newly prescribed a new disease modifying medication for MS (either Ocrevus or Copaxone)
  • or healthy volunteer who can 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): NCT04448977


Contacts
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Contact: Nancy Moore, M.A. 973-324-8450 nbmoore@kesslerfoundation.org
Contact: Angela Smith, M.A. 973-324-8448 asmith@kesslerfoundation.org

Locations
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United States, New Jersey
Kessler Foundation Recruiting
West Orange, New Jersey, United States, 07052
Contact: Nancy B Moore, MA    973-324-8450    nbmoore@kesslerfoundation.org   
Contact: Angela Smith, M.A.    973-324-8448    asmith@kesslerfoundation.org   
Principal Investigator: John DeLuca, PhD         
Sub-Investigator: Ekaterina Dobryakova, PhD         
Sub-Investigator: Helen Genova, PhD         
Sub-Investigator: Glenn Wylie, PhD         
Sub-Investigator: Krupa Pandey, MD         
Sub-Investigator: Florian Thomas, MD         
Sponsors and Collaborators
Kessler Foundation
Hackensack Meridian Health
Investigators
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Principal Investigator: John DeLuca, PhD Kessler Foundation
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Responsible Party: Kessler Foundation
ClinicalTrials.gov Identifier: NCT04448977    
Other Study ID Numbers: R-1104-20
First Posted: June 26, 2020    Key Record Dates
Last Update Posted: July 23, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Ocrelizumab
Immunologic Factors
Physiological Effects of Drugs