An Examination of Cognitive Fatigue Using Functional Neuroimaging

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

Official title:

An Examination of Cognitive Fatigue Using Functional Neuroimaging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04885894
• Other study ID #: R-1150-21
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Kessler Foundation
• Contact: Nancy Moore
• Phone: 973-324-8450
• Email: nbmoore[@]kesslerfoundation.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Kessler Foundation	West Orange	New Jersey

Sponsors (4)

Lead Sponsor	Collaborator
Kessler Foundation	Celgene, Hackensack Meridian Health, St. Barnabas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain activation (BOLD signal)	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 and Modified Fatigue Impact Scale).	Measured for change at 3 time points (before, six months and 12 months after intervention)
Secondary	Fatigue Onset	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 and Modified Fatigue Impact Scale).	Measured for change at 3 time points (before, six months and 12 months after intervention)