Examining Effects of Ocrevus on Cognitive Fatigue Using fMRI

NCT04448977 | Recruiting FDA Drug

• 1 other identifier: R-1104-20
• 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

Keywords

Multiple Sclerosis; cognitive fatigue

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 for change (before, six months and 12 months after intervention)

Study Arms (3)

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

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.

Interventions

Ocrevus DRUG

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 1

Eligibility Criteria

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

Study Population

Individuals who have Relapsing remitting Multiple Sclerosis and Healthy Volunteers

You may qualify if:

• 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.

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
• Hackensack Meridian Health: collaborator

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Interventions

ocrelizumab

Condition Hierarchy (Ancestors)

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, M.A.

CONTACT

973-324-8450; nbmoore@kesslerfoundation.org

Angela Smith, M.A.

CONTACT

973-324-8448; asmith@kesslerfoundation.org

Study Design

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

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 26, 2020
• Study Start: May 6, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)