Recruiting

Cognitive Fatigue

Sponsor:

Kessler Foundation

Code:

NCT04885894

Conditions

Multiple Sclerosis, Relapsing-Remitting

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Accepted

Interventions

Zeposia

Study Details

Brief summary:

The purpose of this research study is to investigate the effectiveness of MS Disease modifying medications 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

Study ID

NCT04885894

Start date

Jan 1, 2022

Status verified date

Feb, 2024

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age between 18-64.
  • Relapsing remitting multiple sclerosis
  • Been newly prescribed a new disease modifying medication for MS (either Zeposia or other high dose oral efficacy medication)
  • or healthy volunteer who can 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

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

MS Zeposia

Individuals with MS who will begin taking Zeposia as part of standard care.

MS High dose efficacy medication

Individuals with MS who will begin taking high dose efficacy oral medication as part of standard of care.

Healthy Control

Healthy controls, all of whom will be matched on age, education and gender to the MS groups.

Interventions

Zeposia

Participants with MS will be divided into two treatment groups: those who will begin to take Zeposia, and those who plan to be begin treatment with high dose oral efficacy medication. The HC group will be free of neurological disease or injury and will be matched to the MS groups for age, gender, and education.

Primary outcome measure

  • Brain activation (BOLD signal) [ Time Frame: Measured for change at 3 time points (before, six months and 12 months after intervention) ]

Central Contacts and Locations

Central contacts

Nancy Moore

973-324-8450nbmoore@kesslerfoundation.org

Amanda PraSisto

973-324-3507aprasisto@kesslerfoundation.org

Locations

Kessler Foundation

Recruiting

West Orange, New Jersey, United States, 07052

Contacts

Amanda PraSisto

973-324-3507aprasisto@kesslerfoundation.org

More Information

Sponsor

Kessler Foundation

Last update posted

Mar 1, 2024

Last verified

Feb, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2024-03-01.