Improving New Learning and Memory in Multiple Sclerosis

NCT00166283 | Completed DMC

• 2 other identifiers: ndcnih2004R01HD045798
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

memory; learning; Multiple Sclerosis; Cognition; treatment; therapy

Outcome Measures

Primary Outcomes (1)

• Scores on memory tests

  Three points in time: pre-treatment, immediately following treatment and 6 months after treatment is completed

Secondary Outcomes (1)

• Reports of emotional functioning, memory functioning, quality of life and neuroimaging.

  Three points in time: pre-treatment, immediately following treatment and 6 months after treatment is completed

Study Arms (2)

experimental group

EXPERIMENTAL

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

placebo control group

PLACEBO COMPARATOR

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

Interventions

memory retraining exercises BEHAVIORAL

Memory retraining exercises will be administered on a laptop computer twice a week for five weeks (10 training sessions).

experimental group

placebo control memory exercises BEHAVIORAL

Placebo control memory exercises will be administered on a laptop computer twice a week for five weeks (10 training sessions).

placebo control group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English as primary language
• diagnosis of multiple sclerosis

You may not qualify if:

• 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

Sponsors & Collaborators

• Kessler Foundation: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Kessler Foundation Research Center

West Orange, New Jersey, 07052, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Nancy D Chiaravalloti, PhD

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 14, 2005
• Study Start: February 1, 2005
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 11, 2013

Record last verified: 2013-06

Locations

US (1)