Examining Effects of Tysabri on Cognitive Fatigue Using fMRI

NCT04565431 | Recruiting FDA Drug

• 1 other identifier: US-TYS-11640
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

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 Task and Modified Fatigue Impact Scale).

  Measured by change between 2 time points (baseline and six months after intervention)

Secondary Outcomes (2)

• Fatigue onset (SDMT)

  Measured by change between 2 time points (baseline and six months after intervention)

• Fatigue onset

  Measured by change between 2 time points (baseline and six months after intervention)

Study Arms (2)

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

Group 2: Healthy Controls

Healthy individuals who are age, gender and education matched to the MS group.

Interventions

Tysabri DRUG

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 1: Multiple Sclerosis

Eligibility Criteria

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

Study Population

Individuals diagnosed with Relapsing-Remitting Multiple Sclerosis and Healthy Volunteers

You may qualify if:

• 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

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
• 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; Multiple Sclerosis

Interventions

Natalizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• John DeLuca, Ph.D.

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nancy Moore, M.A.

CONTACT

19733248450; nbmoore@kesslerfoundation.org

Angela Smith, M.A.

CONTACT

19733248448; 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: August 25, 2020
• First Posted: September 25, 2020
• Study Start: March 19, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 15, 2024

Record last verified: 2024-02

Locations

US (1)