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Treating New Learning and Memory Deficits in Progressive Multiple Sclerosis (MS)

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ClinicalTrials.gov Identifier: NCT02301247
Recruitment Status : Completed
First Posted : November 25, 2014
Last Update Posted : July 2, 2017
Sponsor:
Collaborator:
International Progressive MS Alliance
Information provided by (Responsible Party):
Nancy Chiaravalloti, Kessler Foundation

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Progressive Cognition - Other Memory Impairment Behavioral: Memory retraining exercises Behavioral: Placebo control memory exercises Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Treating New Learning and Memory Deficits in Progressive Multiple Sclerosis (MS)
Study Start Date : November 2014
Actual Primary Completion Date : April 2, 2017
Actual Study Completion Date : April 2, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental Group
The experimental group will receive memory retraining exercises administered on a laptop computer twice a week for 5 weeks (10 training sessions).
Behavioral: Memory retraining exercises
Memory retraining exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).

Placebo Comparator: Placebo
The placebo group will receive placebo control memory exercises administered on a laptop computer twice a week for 5 weeks (10 training sessions).
Behavioral: Placebo control memory exercises
Placebo control memory exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


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Ages Eligible for Study:   30 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301247


Locations
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United States, New Jersey
Kessler Foundation
West Orange, New Jersey, United States, 07052
Sponsors and Collaborators
Kessler Foundation
International Progressive MS Alliance
Investigators
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Study Director: Matthew R Weiner Kessler Foundation

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Responsible Party: Nancy Chiaravalloti, Director, Neuroscience and Neuropsychology Research, Kessler Foundation
ClinicalTrials.gov Identifier: NCT02301247     History of Changes
Other Study ID Numbers: R-839-14
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017

Keywords provided by Nancy Chiaravalloti, Kessler Foundation:
Multiple Sclerosis, Progressive
cognition
memory
treatment

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Memory Disorders
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms