Improving New Learning and Memory in Multiple Sclerosis

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Nancy Chiaravalloti, Kessler Foundation
ClinicalTrials.gov Identifier:
NCT00166283
First received: September 9, 2005
Last updated: June 8, 2013
Last verified: June 2013
  Purpose

The current study is a double-blind, placebo-control randomized clinical trial examining the efficacy of memory retraining in Multiple Sclerosis (MS). Impairment in higher level cognitive processing, such as new learning and memory, is one of the most common deficits in individuals with MS and such deficits have been shown to exert significant negative impact on multiple aspects of everyday life, including occupational and social functioning. Despite these findings, few studies have attempted to treat these cognitive deficits in order to improve the everyday functioning of individuals with MS. Through a small randomized clinical trial, we found that individuals with MS with documented memory impairment show a significant improvement in their memory performance following a treatment protocol designed to facilitate learning. The current proposal will replicate this finding and further evaluate (a) the impact of the treatment on everyday functioning, (b) the long term efficacy of the treatment and (c) the utility of booster sessions in facilitating long-term treatment effects. We will randomly assign individuals with MS, with documented impairment in new learning abilities, to a memory retraining group or a placebo control group. Both groups will undergo baseline, immediate and long-term follow-up assessment consisting of: (1) a traditional neuropsychological battery and (2) an assessment of global functioning examining the impact of the treatment on daily activities. This design will allow us to evaluate the efficacy of this particular memory retraining technique in an MS population through the assessment of cognitive function via a standard evaluation. In addition, we will be able to draw conclusions regarding the impact of this particular memory remediation program on everyday life from questionnaires completed by the participant and a significant other. Optional enrollment in pre- post neuroimaging will also allow us to look at changes in the brain.


Condition Intervention
Multiple Sclerosis
Behavioral: memory retraining exercises
Behavioral: placebo control memory exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving New Learning in Multiple Sclerosis: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Kessler Foundation:

Primary Outcome Measures:
  • Scores on memory tests [ Time Frame: Three points in time: pre-treatment, immediately following treatment and 6 months after treatment is completed ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reports of emotional functioning, memory functioning, quality of life and neuroimaging. [ Time Frame: Three points in time: pre-treatment, immediately following treatment and 6 months after treatment is completed ] [ Designated as safety issue: No ]

Enrollment: 88
Study Start Date: February 2005
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: experimental group
The experimental group will receive memory retraining exercises administered on a laptop computer twice a week for five weeks (10 training sessions).
Behavioral: memory retraining exercises
Memory retraining exercises will be administered on a laptop computer twice a week for five weeks (10 training sessions).
Placebo Comparator: placebo control group
The placebo control group will receive placebo memory exercises administered on a laptop computer twice a week for five weeks (10 placebo control sessions).
Behavioral: placebo control memory exercises
Placebo control memory exercises will be administered on a laptop computer twice a week for five weeks (10 training sessions).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English as primary language
  • diagnosis of multiple sclerosis

Exclusion Criteria:

  • ages less than 30 or greater than 70
  • Most recent exacerbation within one month
  • Other Neurological History: head injury, stroke, seizures, or any other significant neurological history will not be included in the study
  • Medications: persons on steroids, benzodiazepines, and/or neuroleptics will not be included
  • Individuals with an active diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder I or II will be excluded from the study.
  • Poor Visual Acuity (corrected vision in worse eye < 20/60), diplopia, or nystagmus
  • Inability to understand directions and following one, two, and three step commands
  • Intact New Learning and Memory: Only individuals that show impaired performance on a memory test will be included in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00166283

Locations
United States, New Jersey
Kessler Foundation Research Center
West Orange, New Jersey, United States, 07052
Sponsors and Collaborators
Kessler Foundation
Investigators
Principal Investigator: Nancy D Chiaravalloti, PhD Kessler Foundation
  More Information

No publications provided

Responsible Party: Nancy Chiaravalloti, Director, Kessler Foundation
ClinicalTrials.gov Identifier: NCT00166283     History of Changes
Other Study ID Numbers: ndcnih2004, R01HD045798
Study First Received: September 9, 2005
Last Updated: June 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Kessler Foundation:
memory
learning
Multiple Sclerosis
Cognition
treatment
therapy

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014