Multiple Sclerosis, Relapsing-RemittingNCT04885894
An Examination of Cognitive Fatigue Using Functional Neuroimaging
An observational study of Multiple Sclerosis, Relapsing-Remitting, run by Kessler Foundation at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Zeposia
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Individuals with Relapsing Remitting Multiple Sclerosis and Healthy Controls
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
West Orange, New Jersey, 07052
Amanda PraSisto, 973-324-3507, aprasisto@kesslerfoundation.org
Glenn Wylie, PhD
About this study
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.
Read the detailed 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.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Zeposia
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZeposiaDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| MS Zeposia | Individuals with MS who will begin taking Zeposia as part of standard care. Receives: Drug: Zeposia | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured for change at 3 time points (before, six months and 12 months after intervention)
Secondary outcomes (1)
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: Measured for change at 3 time points (before, six months and 12 months after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start1 Jan 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene, Hackensack Meridian Health, St. Barnabas Medical Center
- Responsible party
- Sponsor
- Investigators
- John DeLuca, PhD, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885894
- Sponsor's protocol ID
- R-1150-21
- Status last verified
- Feb 2024
- First submitted
- 11 May 2021
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Examination of Cognitive Fatigue Using Functional Neuroimaging
- ClinicalTrials.gov ID
- NCT04885894
- Acronym / sponsor ID
- R-1150-21
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- Celgene, Hackensack Meridian Health, St. Barnabas Medical Center
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 13 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MS Zeposia | – | Drug: ZeposiaIndividuals 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Individuals with Relapsing Remitting Multiple Sclerosis and Healthy Controls
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZeposiaParticipants 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. | Drug | MS Zeposia |
Primary outcome
Brain activation (BOLD signal)
Time frame: Measured for change at 3 time points (before, six months and 12 months after intervention)
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).
1 secondary outcome
Fatigue Onset
Time frame: Measured for change at 3 time points (before, six months and 12 months after intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John DeLuca, PhD principal investigator
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, Relapsing-Remitting, run by Kessler Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nancy Moore (973-324-8450, nbmoore@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain activation (BOLD signal) (time frame: Measured for change at 3 time points (before, six months and 12 months after intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.