An Examination of Cognitive Fatigue Using Functional Neuroimaging

NCT ID: NCT04885894

Last Updated: 2024-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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The researchers aim is to investigate the effects of disease modifying treatments on cognitive fatigue and on specific brain areas that have been shown to underlie cognitive fatigue in individuals with Multiple Sclerosis (MS). 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.

Conditions

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Multiple Sclerosis, Relapsing-Remitting

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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MS Zeposia

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

Zeposia

Intervention Type DRUG

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.

MS High dose efficacy medication

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

No interventions assigned to this group

Healthy Control

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

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Celgene

INDUSTRY

Sponsor Role collaborator

Hackensack Meridian Health

OTHER

Sponsor Role collaborator

St. Barnabas Medical Center

OTHER

Sponsor Role collaborator

Kessler Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John DeLuca, PhD

Role: PRINCIPAL_INVESTIGATOR

Kessler Foundation

Locations

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Kessler Foundation

West Orange, New Jersey, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Nancy Moore

Role: CONTACT

973-324-8450

Amanda PraSisto

Role: CONTACT

973-324-3507

Facility Contacts

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Amanda PraSisto

Role: primary

973-324-3507

Other Identifiers

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R-1150-21

Identifier Type: -

Identifier Source: org_study_id

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