Examining Effects of Tysabri on Cognitive Fatigue Using fMRI

Kessler Foundation

Status: Enrolling

Conditions: Multiple Sclerosis, Relapsing-Remitting

Treatments: Drug: Tysabri

Study type: Observational

Funder types: Other

Identifiers

NCT04565431

US-TYS-11640

Details and patient eligibility

About

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.

Full description

The researchers aim is to investigate the effects of Tysabri on cognitive fatigue and on specific brain areas that have been shown to underlie cognitive fatigue in individuals with RRMS. 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

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

Trial design

25 participants in 2 patient groups

Group 1: Multiple Sclerosis

Description:

Individuals with RRMS who are going to be starting Tysabri as determined by Neurologist as part of clinical care. Intervention: Drug: Tysabri

Treatment:

Drug: Tysabri

Group 2: Healthy Controls

Description:

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