Treating New Learning and Memory Deficits in Progressive Multiple Sclerosis (MS)
Status: | Completed |
---|---|
Conditions: | Neurology, Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 30 - 59 |
Updated: | 4/2/2016 |
Start Date: | November 2014 |
End Date: | April 2016 |
Contact: | Nancy B Moore, MA |
Email: | nbmoore@kesslerfoundation.org |
Phone: | 973-324-8450 |
This study is a double-blind placebo-controlled randomized clinical trial (RCT) to provide
Class I evidence in support of or in refute of the efficacy of the modified Story Memory
Technique (mSMT) in persons with progressive MS, with outcome measured through three
mechanisms: (1) a traditional neuropsychological evaluation (NPE) (2) an assessment of
global functioning (AGF) examining the impact of the treatment on daily activities, and (3)
an optional functional magnetic resonance imaging (fMRI) scan.
Class I evidence in support of or in refute of the efficacy of the modified Story Memory
Technique (mSMT) in persons with progressive MS, with outcome measured through three
mechanisms: (1) a traditional neuropsychological evaluation (NPE) (2) an assessment of
global functioning (AGF) examining the impact of the treatment on daily activities, and (3)
an optional functional magnetic resonance imaging (fMRI) scan.
There is a clear unmet need in the clinical care of persons with Progressive MS - there are
no treatments for memory dysfunction with demonstrated efficacy in persons with progressive
disease. This is despite the fact that cognitive impairment is a major contributor to
unemployment and decreased functional status in MS and memory deficits are a major source of
such disability. The investigator recent RCT's demonstrated the modified Story Memory
Technique (mSMT) to be effective for improving new learning and memory in individuals with
MS, demonstrating efficacy across three realms of functioning, objective behavior, brain
functioning and everyday life. This convincing data provides Class I evidence supporting the
efficacy of the mSMT for improving new learning and memory in MS. However, treatment
efficacy was not adequately tested in the progressive MS population. This is a major
limitation due to the fact that progressive MS carries with it major cognitive difficulties,
of which learning and memory are one of the most common. The currently proposed RCT will
address this limitation. The investigators will use methodologically vigorous research
design to provide Class I evidence in support of or in refute of the efficacy of the mSMT in
persons with progressive MS, with outcome measured through three mechanisms: (1) a
traditional neuropsychological evaluation (NPE) (2) an assessment of global functioning
(AGF) examining the impact of the treatment on daily activities and (3) an optional
functional magnetic resonance imaging (fMRI) scan. Both groups will undergo baseline,
immediate follow-up, and 3-month follow-up assessments
Thus, the current study will objectively evaluate the clinical utility of the mSMT to
improve new learning and memory in individuals with progressive MS with documented deficits
in this area. This protocol has been previously utilized in a Relapsing-Remitting MS sample,
yielding exceptional outcome data. Pilot data in a small sample of progressive MS patients
is promising. The investigators will also increase the generalizability and real life
application of assessment techniques by assessing outcome following cognitive retraining
with more global measures of everyday life. Finally, the long-term efficacy of the mSMT will
be evaluated in progressive MS through the inclusion of a 3-month follow-up assessment.
Given the absence of any treatment for impaired learning and memory in progressive patients,
the results of the present RCT will have a significant impact on symptom management and
quality of life for persons with Progressive MS.
no treatments for memory dysfunction with demonstrated efficacy in persons with progressive
disease. This is despite the fact that cognitive impairment is a major contributor to
unemployment and decreased functional status in MS and memory deficits are a major source of
such disability. The investigator recent RCT's demonstrated the modified Story Memory
Technique (mSMT) to be effective for improving new learning and memory in individuals with
MS, demonstrating efficacy across three realms of functioning, objective behavior, brain
functioning and everyday life. This convincing data provides Class I evidence supporting the
efficacy of the mSMT for improving new learning and memory in MS. However, treatment
efficacy was not adequately tested in the progressive MS population. This is a major
limitation due to the fact that progressive MS carries with it major cognitive difficulties,
of which learning and memory are one of the most common. The currently proposed RCT will
address this limitation. The investigators will use methodologically vigorous research
design to provide Class I evidence in support of or in refute of the efficacy of the mSMT in
persons with progressive MS, with outcome measured through three mechanisms: (1) a
traditional neuropsychological evaluation (NPE) (2) an assessment of global functioning
(AGF) examining the impact of the treatment on daily activities and (3) an optional
functional magnetic resonance imaging (fMRI) scan. Both groups will undergo baseline,
immediate follow-up, and 3-month follow-up assessments
Thus, the current study will objectively evaluate the clinical utility of the mSMT to
improve new learning and memory in individuals with progressive MS with documented deficits
in this area. This protocol has been previously utilized in a Relapsing-Remitting MS sample,
yielding exceptional outcome data. Pilot data in a small sample of progressive MS patients
is promising. The investigators will also increase the generalizability and real life
application of assessment techniques by assessing outcome following cognitive retraining
with more global measures of everyday life. Finally, the long-term efficacy of the mSMT will
be evaluated in progressive MS through the inclusion of a 3-month follow-up assessment.
Given the absence of any treatment for impaired learning and memory in progressive patients,
the results of the present RCT will have a significant impact on symptom management and
quality of life for persons with Progressive MS.
Inclusion Criteria:
- between the ages of 30 and 59
- diagnosed with Progressive Multiple Sclerosis
- have visual acuity of better then 20/60 in worse eye
Exclusion Criteria:
- has a prior stroke or neurological injury/disease (brain tumor, epilepsy, traumatic
brain injury).
- has a history of psychiatric illness (for example, bipolar disorder, schizophrenia,
or psychosis).
- currently taking medications such as: steroids, benzodiazepines, and neuroleptics. .
- difficulty with vision, eyesight worse then 20/60, or has diminished sight in visual
field, double vision, or nystagmus.
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