Investigating Tysabri's effects on cognitive fatigue in multiple sclerosis
Biomarker for Cognitive Fatigue Using Functional Imaging in Multiple Sclerosis
This study is testing how the medication Tysabri affects cognitive fatigue in people with Relapsing-Remitting Multiple Sclerosis to see if it helps them feel less tired when thinking.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Kessler Foundation Academic / other |
| Locations | 1 site (West Orange, New Jersey) |
| Trial ID | NCT04565431 on ClinicalTrials.gov |
What this trial studies
This research examines how Tysabri affects cognitive fatigue in individuals with Relapsing-Remitting Multiple Sclerosis (RRMS). The study utilizes fMRI to assess changes in brain activity related to cognitive fatigue during demanding tasks. Participants will be newly prescribed Tysabri and will undergo evaluations to measure cognitive fatigue before and after treatment. The goal is to understand the relationship between Tysabri treatment and cognitive fatigue over time.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-64 who have been newly prescribed Tysabri for RRMS.
Not a fit: Patients with significant neurological events, psychiatric illnesses, or those unable to undergo MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of cognitive fatigue in patients with RRMS.
How similar studies have performed: While studies on cognitive fatigue in MS exist, the specific investigation of Tysabri's effects using fMRI is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
West Orange, New Jersey
- Kessler Foundation — West Orange, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: John DeLuca, Ph.D. — Kessler Foundation
- Study coordinator: Nancy Moore, M.A.
- Email: nbmoore@kesslerfoundation.org
- Phone: 19733248450
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.