Examining Effects of Tysabri on Cognitive Fatigue Using fMRI

Recruiting

• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Interventions: Drug: Tysabri

• Registration Number: NCT04565431
• Lead Sponsor: Kessler Foundation

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-08-25
• Study First Submitted QC: 2020-09-24
• Study First Posted: 2020-09-25
• Study Start: 2021-03-19
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-15
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1: Multiple Sclerosis	Tysabri	Individuals with RRMS who are going to be starting Tysabri as determined by Neurologist as part of clinical care. Intervention: Drug: Tysabri

Primary Outcome Measures

Name	Time	Method
Brain activation (BOLD signal)	Measured by change between 2 time points (baseline and six months after intervention)	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).

Secondary Outcome Measures

Name	Time	Method
Fatigue onset (SDMT)	Measured by change between 2 time points (baseline and six months after intervention)	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)
Fatigue onset	Measured by change between 2 time points (baseline and six months after intervention)	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 Modified Fatigue Impact Scale)

Trial Locations

Locations (1)

Kessler Foundation; 🇺🇸 West Orange, New Jersey, United States