Treating New Learning and Memory Deficits in Progressive Multiple Sclerosis (MS)
Condition: Multiple Sclerosis, Progressive; Cognition - Other; Memory Impairment
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Memory Disorders; Sclerosis
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Memory retraining exercises; Placebo control memory exercises
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Memory retraining exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).; Placebo control memory exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Multiple Sclerosis, Progressive; cognition; memory; treatment