Treating New Learning and Memory Deficits in Progressive Multiple Sclerosis (MS)
Primary Purpose
Multiple Sclerosis, Progressive, Cognition - Other, Memory Impairment
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Memory retraining exercises
Placebo control memory exercises
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis, Progressive focused on measuring Multiple Sclerosis, Progressive, cognition, memory, treatment
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.
Sites / Locations
- Kessler Foundation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental Group
Placebo
Arm Description
The experimental group will receive memory retraining exercises administered on a laptop computer twice a week for 5 weeks (10 training sessions).
The placebo group will receive placebo control memory exercises administered on a laptop computer twice a week for 5 weeks (10 training sessions).
Outcomes
Primary Outcome Measures
Change in scores on standardized neuropsychological tests of memory
Secondary Outcome Measures
Change in scores on self-report of emotional functioning, measured via questionnaire
Change in scores on self-report of memory functioning, measured via questionnaire
Change in scores on self-report of quality of life, measured via questionnaire
Full Information
NCT ID
NCT02301247
First Posted
November 17, 2014
Last Updated
June 30, 2017
Sponsor
Kessler Foundation
Collaborators
International Progressive MS Alliance
1. Study Identification
Unique Protocol Identification Number
NCT02301247
Brief Title
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
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
April 2, 2017 (Actual)
Study Completion Date
April 2, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kessler Foundation
Collaborators
International Progressive MS Alliance
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Progressive, Cognition - Other, Memory Impairment
Keywords
Multiple Sclerosis, Progressive, cognition, memory, treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
The experimental group will receive memory retraining exercises administered on a laptop computer twice a week for 5 weeks (10 training sessions).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The placebo group will receive placebo control memory exercises administered on a laptop computer twice a week for 5 weeks (10 training sessions).
Intervention Type
Behavioral
Intervention Name(s)
Memory retraining exercises
Intervention Description
Memory retraining exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).
Intervention Type
Behavioral
Intervention Name(s)
Placebo control memory exercises
Intervention Description
Placebo control memory exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).
Primary Outcome Measure Information:
Title
Change in scores on standardized neuropsychological tests of memory
Time Frame
Scores will be assessed at three time-points: Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention
Secondary Outcome Measure Information:
Title
Change in scores on self-report of emotional functioning, measured via questionnaire
Time Frame
Scores will be assessed at three time-points: Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention
Title
Change in scores on self-report of memory functioning, measured via questionnaire
Time Frame
Scores will be assessed at three time-points: Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention
Title
Change in scores on self-report of quality of life, measured via questionnaire
Time Frame
Scores will be assessed at three time-points: Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew R Weiner
Organizational Affiliation
Kessler Foundation
Official's Role
Study Director
Facility Information:
Facility Name
Kessler Foundation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Treating New Learning and Memory Deficits in Progressive Multiple Sclerosis (MS)
We'll reach out to this number within 24 hrs