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Brain scans may reveal how MS drug affects mental fatigue

NCT ID NCT04565431

Knowledge-focused Sponsor: Kessler Foundation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This study explores whether the medication Tysabri can reduce cognitive fatigue—the tiredness that comes after intense mental effort—in people with relapsing-remitting multiple sclerosis (RRMS). Researchers will compare brain activity, measured with functional MRI, between RRMS patients starting Tysabri and healthy volunteers matched by age, gender, and education. The goal is to see if changes in brain activation correlate with fatigue levels, potentially identifying a biomarker for cognitive fatigue in MS.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tysabri (natalizumab), a drug used to treat multiple sclerosis
What this could lead to
If successful, this could point toward a way to measure and treat cognitive fatigue in multiple sclerosis, improving daily life for patients.
What could go wrong
This is a very small early-stage study (7 participants), so results may not apply broadly. It focuses on brain imaging markers rather than direct patient outcomes, and the drug may have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

7 people

The number who actually took part.

Started

Mar 2021

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Individuals diagnosed with Relapsing-Remitting Multiple Sclerosis and Healthy Volunteers

Ages

18 to 64 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

multiple sclerosis relapsing-remitting multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple sclerosis, relapsing-remitting

Contacts and locations

Locations

  • Kessler Foundation

    West Orange, New Jersey, 07052, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.