An Examination of Cognitive Fatigue Using Functional Neuroimaging

NCT04885894 | Recruiting

• 1 other identifier: R-1150-21
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Outcome Measures

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 and Modified Fatigue Impact Scale).

  Measured for change at 3 time points (before, six months and 12 months after intervention)

Secondary Outcomes (1)

• Fatigue Onset

  Measured for change at 3 time points (before, six months and 12 months after intervention)

Study Arms (3)

MS Zeposia

Individuals with MS who will begin taking Zeposia as part of standard care.

Drug: Zeposia

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.

Interventions

Zeposia DRUG

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 Zeposia

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Individuals with Relapsing Remitting Multiple Sclerosis and Healthy Controls

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kessler Foundation: lead
• Celgene: collaborator
• Hackensack Meridian Health: collaborator
• St. Barnabas Medical Center: collaborator

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

ozanimod

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• John DeLuca, PhD

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nancy Moore

CONTACT

973-324-8450; nbmoore@kesslerfoundation.org

Amanda PraSisto

CONTACT

973-324-3507; aprasisto@kesslerfoundation.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 13, 2021
• Study Start: January 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)