Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00391352
Status:
COMPLETED
Last Update Posted:
2014-06-04
First Post:
2006-10-19
Brief Title:
fMRI Study of Treatment Recommendations Comparing Recently Diagnosed Multiple Sclerosis MS Patients to Controls
Sponsor:
Waukesha Memorial Hospital
Organization:
Waukesha Memorial Hospital
Study Overview
Official Title:
A Phase 4 fMRI Study of Treatment Recommendations Comparing Patients Taking IFN-β-1a 44 mcg Tiw SC Rebif to Controls of Patients Recently Diagnosed With Relapsing Remitting Multiple Sclerosis Currently Naive to Disease-Modifying Therapy
Status:
COMPLETED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Impaired short term memory attention and concentration lapses and slower processing of information occur in up to 40-65 of patients with Multiple Sclerosis MS The quality of life of individuals with MS is impacted to the degree with which they experience these symptoms
There are several medications approved by the United States Food and Drug Administration FDA to treat MS symptoms and to modify slow disease course Traditional approaches to determining the effectiveness of medications used in treating MS rely on reports of the number of relapses an individual experiences as well as standard clinical tests such as the Kurtzke Expanded Disability Status Scale EDSS
This research study will look at whether the functional magnetic resonance imaging fMRI scan can be used as a tool for measuring changes in the brain associated with treatment in MS patients Unlike a typical MRI which provides structural information about the brain the fMRI provides information about brain activity during performance of cognitive or motor tasks
There are several medications approved by the United States Food and Drug Administration FDA to treat MS symptoms and to modify slow disease course Traditional approaches to determining the effectiveness of medications used in treating MS rely on reports of the number of relapses an individual experiences as well as standard clinical tests such as the Kurtzke Expanded Disability Status Scale EDSS
This research study will look at whether the functional magnetic resonance imaging fMRI scan can be used as a tool for measuring changes in the brain associated with treatment in MS patients Unlike a typical MRI which provides structural information about the brain the fMRI provides information about brain activity during performance of cognitive or motor tasks
Detailed Description:
The development of the immunomodulatory disease-modifying therapies DMT represents a major advance for the treatment of multiple sclerosis MS To date immunomodulatory agents approved for the treatment of MS in the United States include two forms of recombinant interferon-beta IFN-beta-1a Avonex Rebif and IFN-beta-1b Betaseron and synthetic glatiramer acetate Copaxone These drugs have been shown to favorably alter the natural history of relapsing remitting MS by slowing the progression of disability reducing relapse rate and decreasing brain inflammation as measured by MRI There is evidence that the treatment effects of both IFN-beta and glatiramer acetate are related to their properties in regulating various components of the immune system in particular the T cell functions eg proliferation and migratory behavior and cytokine production
Though demonstrating clear efficacy on a number of short-term clinical measures these agents are not cures and most patients with MS continue to experience disease activity in spite of treatment Over the last ten years clinicians have become comfortable initiating therapy with DMT Now attention is focused on monitoring the results of a chosen therapy and deciding whether or not a patient is responding optimally to treatment At present however clinicians lack criteria for defining optimal response to DMT as well as evidence-based recommendations on how to improve treatment outcomes for individual patients
Using a recently published model generated by an advisory board from the United States as a framework The Canadian Multiple Sclerosis Working Group CMSWG developed practical evidence-based recommendations on how neurologists can assess the status of patients on DMT and decide when it may be necessary to modify treatment in order to optimize outcomes The CMSWGs recommendations are based on monitoring relapses neurological progression and MRI activity These recommendations have yet to be implemented in a prospective randomized comparative Phase IV clinical trial
Traditional measures do not provide critical information about the neural systems that underlie change in behavioral performance The goal of developing a surrogate biological marker of drug efficacy is to be able to measure the extent to which a drug reaches its intended targeted neural system and to understand and predict the impact of treatment on existing neuropathology Ideally relevant clinical outcome measures should be well correlated with the biomarker
fMRI is a new tool for noninvasive imaging of human brain function Without the use of contrast agents fMRI detects regional MR signal increases that have been hypothesized to reflect decreases in deoxyhemoglobin due to local increases in blood flowvolume during task activation fMRI has higher spatial and temporal resolution than other existing functional imaging techniques making it ideal for the study of complex cognitive functions in patient populations
Though demonstrating clear efficacy on a number of short-term clinical measures these agents are not cures and most patients with MS continue to experience disease activity in spite of treatment Over the last ten years clinicians have become comfortable initiating therapy with DMT Now attention is focused on monitoring the results of a chosen therapy and deciding whether or not a patient is responding optimally to treatment At present however clinicians lack criteria for defining optimal response to DMT as well as evidence-based recommendations on how to improve treatment outcomes for individual patients
Using a recently published model generated by an advisory board from the United States as a framework The Canadian Multiple Sclerosis Working Group CMSWG developed practical evidence-based recommendations on how neurologists can assess the status of patients on DMT and decide when it may be necessary to modify treatment in order to optimize outcomes The CMSWGs recommendations are based on monitoring relapses neurological progression and MRI activity These recommendations have yet to be implemented in a prospective randomized comparative Phase IV clinical trial
Traditional measures do not provide critical information about the neural systems that underlie change in behavioral performance The goal of developing a surrogate biological marker of drug efficacy is to be able to measure the extent to which a drug reaches its intended targeted neural system and to understand and predict the impact of treatment on existing neuropathology Ideally relevant clinical outcome measures should be well correlated with the biomarker
fMRI is a new tool for noninvasive imaging of human brain function Without the use of contrast agents fMRI detects regional MR signal increases that have been hypothesized to reflect decreases in deoxyhemoglobin due to local increases in blood flowvolume during task activation fMRI has higher spatial and temporal resolution than other existing functional imaging techniques making it ideal for the study of complex cognitive functions in patient populations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None