An Examination of Cognitive Fatigue Using Functional Neuroimaging

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.

Study Overview

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

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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Nancy Moore; Phone Number: 973-324-8450; Email: nbmoore@kesslerfoundation.org
• Study Contact Backup: Name: Amanda PraSisto; Phone Number: 973-324-3507; Email: aprasisto@kesslerfoundation.org

Study Locations

• United States
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • Recruiting
      • Kessler Foundation
      • Sub-Investigator: Helen Genova, PhD
      • Sub-Investigator: Glenn Wylie, PhD
      • Contact: Amanda PraSisto; Phone Number: 973-324-3507; Email: aprasisto@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 with Relapsing Remitting Multiple Sclerosis and Healthy Controls

Description

Inclusion Criteria:

• Age between 18-64.
• Relapsing remitting multiple sclerosis
• Been newly prescribed a new disease modifying medication for MS (either Zeposia or other high dose oral efficacy medication)
• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MS Zeposia; Individuals with MS who will begin taking Zeposia as part of standard care.	Drug: Zeposia; Participants with MS will be divided into two treatment groups: those who will begin to take Zeposia, and those who plan to be begin treatment with high dose oral efficacy medication. The HC group will be free of neurological disease or injury and will be matched to the MS groups for age, gender, and education.
MS High dose efficacy medication; Individuals with MS who will begin taking high dose efficacy oral medication as part of standard of care.
Healthy Control; Healthy controls, all of whom will be matched on age, education and gender to the MS groups.

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 and Modified Fatigue Impact Scale).	Measured for change at 3 time points (before, six months and 12 months after intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue Onset	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).	Measured for change at 3 time points (before, six months and 12 months after intervention)

Collaborators and Investigators

• Sponsor: Kessler Foundation
• Collaborators: Celgene; Hackensack Meridian Health; St. Barnabas Medical Center
• Investigators: Principal Investigator: John DeLuca, PhD, Kessler Foundation

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 11, 2021
• First Submitted That Met QC Criteria: May 11, 2021
• First Posted (Actual): May 13, 2021

Study Record Updates

• Last Update Posted (Actual): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Immunosuppressive Agents; Immunologic Factors; Sphingosine 1 Phosphate Receptor Modulators; Ozanimod
• Other Study ID Numbers: R-1150-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No