Clinical trial NCT02301247: Treating New Learning and Memory Deficits in Progressive Multiple Sclerosis (MS)
Official title: Treating New Learning and Memory Deficits in Progressive Multiple Sclerosis (MS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis, Progressive
Cognition - Other
Memory Impairment
Keywords: Multiple Sclerosis, Progressive
cognition
memory
treatment
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: International Progressive MS Alliance
First posted: 2014-11-25
Enrollment: 32
Sex: ALL
Minimum age (years): 30
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in scores on standardized neuropsychological tests of memory
timeFrame: Scores will be assessed at three time-points: Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention
Secondary outcomes:
measure: Change in scores on self-report of emotional functioning, measured via questionnaire
timeFrame: Scores will be assessed at three time-points: Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention
measure: Change in scores on self-report of memory functioning, measured via questionnaire
timeFrame: Scores will be assessed at three time-points: Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention
measure: Change in scores on self-report of quality of life, measured via questionnaire
timeFrame: Scores will be assessed at three time-points: Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Matthew R Weiner
role: STUDY_DIRECTOR
References: