Multiple Sclerosis, Relapsing-RemittingNeuroQuantNCT05684016
Assessment of Deep Gray Matter Anatomic Changes in RRMS Patients Treated With Gilenya® With and Without Cognitive Impairment Over a 2 Year Period Using NeuroQuant, NeuroQuarc and ANAM
A study testing NeuroQuant, Automated Neuropsychological Assessment Matrices and EDSS in people with Multiple Sclerosis, Relapsing-Remitting, run by George Washington University at 1 site in United States.
Trial summary
The purpose of the research study is to investigate whether the extent and severity of lesions in the brain as measured by special MRI techniques can distinguish between Multiple Sclerosis (MS) patients with or without memory impairment and also between MS patients and age matched healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- NeuroQuant, Automated Neuropsychological Assessment Matrices and EDSS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Dec 2016
- Phase
- Interventional
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- RRMS Patients
- Male and Female adult definite RRMS patients with or without cognitive complaint
- Age range 18-55 years old
- Patients treated with Gilenya® (fingolimod) and other immunomodulating MS therapies
- Able to provide informed consent
- Male and Female adult with normal brain MRI and Neurological Examination
Show all 9Show fewer
- Headaches or dizziness
- Age range 18-55 years
- Able to provide informed consent
Who cannot join
- Pregnant or breastfeeding women
- Patients with an infectious disease
- Patients with any other medical or neurological condition that could affect cognition
- Inability to communicate in English
- Patients with clinically or radiologically isolated syndrome (CIS, RIS)
- Primary or Secondary Progressive forms of MS
Show all 16Show fewer
- Current or past medical, neurological or psychiatric disorders (other than MS)
- Previous illicit substance dependence or substance abuse
- Pulse or steroid therapy within 8 weeks or preceding evaluation
- Current major depressive episode
- Control Patients
- Patients with an infectious disease
- Patients with any other medical or neurological condition that could affect cognition
- Inability to provide informed consent
- Inability to communicate in English
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country.
United States1 site
The George Washignton University
Washington D.C., District of Columbia, 20037
About this study
Official title: Assessment of Deep Gray Matter Anatomic Changes in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Treated With Gilenya® (Fingolimod) With and Without Cognitive Impairment Over a 2 Year Period Using 3 Dimensional Volumetric MRI Studies (NeuroQuant, NeuroQuarc) and Automated Neuropsychological Assessment Matrices (ANAM)
The purpose of the research study is to investigate whether the extent and severity of lesions in the brain as measured by special MRI techniques can distinguish between Multiple Sclerosis (MS) patients with or without memory impairment and also between MS patients and age matched healthy controls.
Read the detailed description
Impairment in thinking or memory is frequently present in multiple sclerosis but there are difficulties finding changes on the Brain MRI that correlate with impairment in thinking and memory. This occurs because standard MRI is good for detecting some but not all abnormalities in the brain. Those lesions that we do see in the brain on standard MRI do not correlate with memory impairment or the source of disability in most RRMS patients. This occurs because RRMS symptoms mainly result from parts of the brain which have been hard to evaluate with MRI until now.
To gain more insight into the source of memory impairment, we plan to explore differences in brain volume that may be present in RRMS patients without thinking or memory problems compared with those who are impaired. A secondary objective will be to compare RRMS patients in general with healthy controls.
A new MRI technique called NeuroQuant which reliably defines the volume of those parts of the brain that are important for memory and thinking will be used. Neuropsychological testing will also be offered, at no cost, to those patients being treated with Gilenya® in order to help define the presence and extent of their memory impairment. Automated Neuropsychological Assessment Matrices (ANAM)looks at all functional brain systems and will be administered by a psychometrist over a period of 90 minutes.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- NeuroQuant, Automated Neuropsychological Assessment Matrices, EDSS, Physical Examination
- Keywords
- Relapsing Remitting Multiple Sclerosis, RRMS, Gilenya, Fingolimod, MRI, NeuroQuant, NeuroQuarc, Automated Neuropsychological Assessment Matrices, ANAM
- 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.
NeuroQuantOther
Reliably defines the volume of those parts of the brain that are important for memory and thinking.
Automated Neuropsychological Assessment MatricesOther
This is like an IQ test.
EDSSOther
Extended Disability Status Score
Physical ExaminationOther
Physical Examination
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | A control population (Non RRMS) will include a minimum of 20 age and gender matched healthy patients from the George Washington University (GWU) neurology outpatient clinic (being compared with those RRMS patients being treated with Gilenya® ) for whom Brain MRI's are being ordered as a result of their having headaches, dizziness, or other conditions where there is no physical evidence for neurologic impairment. All control patients will only be recruited by the full time Neurology Faculty at the GWU Medical Faculty Associates (MFA). Control patients will be asked to consent to have NeuroQuant added to their routine Brain MRI which will add 7 minutes to their time in the MRI scanner to obtain additional image data. Receives: Other: NeuroQuant; Other: Automated Neuropsychological Assessment Matrices |
| MS Subject on Gilenya | Active comparator | All the RRMS patients will have their Brain MRI with the addition of NeuroQuant. The 30 patients that are taking Gilenya® will have serial NeuroQuant/MRI and Neuropsychological testing (which is like an IQ test) using Automated Neuropsychological Assessment Matrices (ANAM) whether they are or are not experiencing cognitive issues. In addition, each study patient will undergo Extended Disability Status Score (EDSS) evaluation by a physician or a physician assistant at baseline and at 1 and 2 years. A group of 20 RRMS patients will undergo a second Brain MRI (not standard of care) with NeuroQuant evaluation 7 to 14 days after the initial study in order to confirm the reproducibility of this imaging technique. The cost for this repeat MRI will not be charged to you but will be borne by the sponsors of this study Receives: Other: NeuroQuant; Other: Automated Neuropsychological Assessment Matrices; Other: EDSS; Other: Physical Examination |
| MS Subject not on Gilenya | Active comparator | All the RRMS patients will have their Brain MRI with the addition of NeuroQuant. Receives: Other: NeuroQuant; Other: EDSS; Other: Physical Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in size of brain region by cm3 over a 2 year period in RRMS patients with and without cognitive impairment compared to healthy age matched controls
- Utilizing MRI 3 dimensional volumetric analysis (NeuroQuant) to detect gray matter changes in RRMS with or without cognitive impairment and compare results with normal demographically similar age matched controls.
Measured: 2 Years
Secondary outcomes (2)
Determine in patients with RRMS treated with Gilenya®, the changes on various gray matter volume as assessed by serial NeuroQuant/NeuroQuarc 3 dimensional volumetric analysis over a 2 year period.
- Use serial MRI 3 dimensional volumetric analysis (NeuroQuant) at baseline, 1 week (in 20 patients) and 1 and 2 years to assess reproducibility of NeuroQuant, and determine the degree of preservation of gray matter structures in RRMS patients treated with Gilenya® over a period of 2 years.
Measured: 2 Years
Compare Neuropsychological Evaluations using ANAM to address cognitive changes in patients treated with Gilenya over time as compared to healthy aged matched control patients.
Baseline neuropsychological evaluations on patients treated with Gilenya based on results of an Automated Neuropsychological Assessment Matrices (ANAM). Healthy controls will also undergo this neuropsychological assessment. Both groups will be repeatedly tested over time for 2 years.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study startDec 2013
- Primary completionSep 2016
- Study completionDec 2016
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 George Washington UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ted Rothstein, George Washington University
- Investigators
- Ted Rothstein, MD, Principal investigator, The George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684016
- Sponsor's protocol ID
- ADEG-MS-3DV
- Acronym
- NeuroQuant
- Status last verified
- Jan 2023
- First submitted
- 8 Jan 2015
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Deep Gray Matter Anatomic Changes in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Treated With Gilenya® (Fingolimod) With and Without Cognitive Impairment Over a 2 Year Period Using 3 Dimensional Volumetric MRI Studies (NeuroQuant, NeuroQuarc) and Automated Neuropsychological Assessment Matrices (ANAM)
- ClinicalTrials.gov ID
- NCT05684016
- Acronym / sponsor ID
- NeuroQuant / ADEG-MS-3DV
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Relapsing Remitting Multiple Sclerosis, RRMS, Gilenya, Fingolimod, MRI, NeuroQuant, NeuroQuarc, Automated Neuropsychological Assessment Matrices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 13 Jan 2023 (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 the research study is to investigate whether the extent and severity of lesions in the brain as measured by special MRI techniques can distinguish between Multiple Sclerosis (MS) patients with or without memory impairment and also between MS patients and age matched healthy controls.
Detailed description
Impairment in thinking or memory is frequently present in multiple sclerosis but there are difficulties finding changes on the Brain MRI that correlate with impairment in thinking and memory. This occurs because standard MRI is good for detecting some but not all abnormalities in the brain. Those lesions that we do see in the brain on standard MRI do not correlate with memory impairment or the source of disability in most RRMS patients. This occurs because RRMS symptoms mainly result from parts of the brain which have been hard to evaluate with MRI until now.
To gain more insight into the source of memory impairment, we plan to explore differences in brain volume that may be present in RRMS patients without thinking or memory problems compared with those who are impaired. A secondary objective will be to compare RRMS patients in general with healthy controls.
A new MRI technique called NeuroQuant which reliably defines the volume of those parts of the brain that are important for memory and thinking will be used. Neuropsychological testing will also be offered, at no cost, to those patients being treated with Gilenya® in order to help define the presence and extent of their memory impairment. Automated Neuropsychological Assessment Matrices (ANAM)looks at all functional brain systems and will be administered by a psychometrist over a period of 90 minutes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: NeuroQuant, Other: Automated Neuropsychological Assessment MatricesA control population (Non RRMS) will include a minimum of 20 age and gender matched healthy patients from the George Washington University (GWU) neurology outpatient clinic (being compared with those RRMS patients being treated with Gilenya® ) for whom Brain MRI's are being ordered as a result of their having headaches, dizziness, or other conditions where there is no physical evidence for neurologic impairment. All control patients will only be recruited by the full time Neurology Faculty at the GWU Medical Faculty Associates (MFA). Control patients will be asked to consent to have NeuroQuant added to their routine Brain MRI which will add 7 minutes to their time in the MRI scanner to obtain additional image data. |
| MS Subject on Gilenya | Active comparator | Other: NeuroQuant, Other: Automated Neuropsychological Assessment Matrices, Other: EDSS, Other: Physical ExaminationAll the RRMS patients will have their Brain MRI with the addition of NeuroQuant. The 30 patients that are taking Gilenya® will have serial NeuroQuant/MRI and Neuropsychological testing (which is like an IQ test) using Automated Neuropsychological Assessment Matrices (ANAM) whether they are or are not experiencing cognitive issues. In addition, each study patient will undergo Extended Disability Status Score (EDSS) evaluation by a physician or a physician assistant at baseline and at 1 and 2 years. A group of 20 RRMS patients will undergo a second Brain MRI (not standard of care) with NeuroQuant evaluation 7 to 14 days after the initial study in order to confirm the reproducibility of this imaging technique. The cost for this repeat MRI will not be charged to you but will be borne by the sponsors of this study |
| MS Subject not on Gilenya | Active comparator | Other: NeuroQuant, Other: EDSS, Other: Physical ExaminationAll the RRMS patients will have their Brain MRI with the addition of NeuroQuant. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- RRMS Patients
- Male and Female adult definite RRMS patients with or without cognitive complaint
- Age range 18-55 years old
- Patients treated with Gilenya® (fingolimod) and other immunomodulating MS therapies
- Able to provide informed consent
Key exclusion criteria (16 listed)
- Pregnant or breastfeeding women
- Patients with an infectious disease
- Patients with any other medical or neurological condition that could affect cognition
- Inability to communicate in English
- Patients with clinically or radiologically isolated syndrome (CIS, RIS)
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 |
|---|---|---|
| NeuroQuantReliably defines the volume of those parts of the brain that are important for memory and thinking. | Other | Control, MS Subject not on Gilenya, MS Subject on Gilenya |
| Automated Neuropsychological Assessment MatricesThis is like an IQ test. | Other | Control, MS Subject on Gilenya |
| EDSSExtended Disability Status Score | Other | MS Subject not on Gilenya, MS Subject on Gilenya |
| Physical ExaminationPhysical Examination | Other | MS Subject not on Gilenya, MS Subject on Gilenya |
Primary outcome
Changes in size of brain region by cm3 over a 2 year period in RRMS patients with and without cognitive impairment compared to healthy age matched controls
Time frame: 2 Years
a. Utilizing MRI 3 dimensional volumetric analysis (NeuroQuant) to detect gray matter changes in RRMS with or without cognitive impairment and compare results with normal demographically similar age matched controls.
2 secondary outcomes
Determine in patients with RRMS treated with Gilenya®, the changes on various gray matter volume as assessed by serial NeuroQuant/NeuroQuarc 3 dimensional volumetric analysis over a 2 year period.
Time frame: 2 Years
Compare Neuropsychological Evaluations using ANAM to address cognitive changes in patients treated with Gilenya over time as compared to healthy aged matched control patients.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
Related trials for Multiple Sclerosis, Relapsing-Remitting
Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
Recruiting
Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study
Multiple Sclerosis (MS) - Relapsing-remitting, Upper Extremity Dysfunction
Not yet recruiting
Treatment of Memory Retrieval Impairments in MS With HDtDCS to the LIFG in a Placebo Controlled Trial
Multiple Sclerosis, Relapsing-remitting Multiple Sclerosis (RRMS)
Recruiting
Monthly Monitoring of Plasma NfL in Treated Relapsing-remitting Multiple Sclerosis to Detect Persistent Infraclinical Disease Activity
Multiple Sclerosis (MS) - Relapsing-remitting
Active, not recruitingPhase 4
Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis
Multiple Sclerosis
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.
Ted Rothstein, MD principal investigator
The George Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuroQuant, Automated Neuropsychological Assessment Matrices and EDSS in people with Multiple Sclerosis, Relapsing-Remitting, run by George Washington University 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 9 inclusion and 16 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: finished, as of the sponsor's last update on 13 Jan 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in size of brain region by cm3 over a 2 year period in RRMS patients with and without cognitive impairment compared to healthy age matched controls (time frame: 2 Years). 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 13 Jan 2023.