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Development and Evaluation of a Cognitive Rehabilitation Program for Persons With Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT01303770
Recruitment Status : Unknown
Verified December 2013 by Eynat Shevil, Tel Aviv University.
Recruitment status was:  Active, not recruiting
First Posted : February 25, 2011
Last Update Posted : December 25, 2013
Sponsor:
Information provided by (Responsible Party):
Eynat Shevil, Tel Aviv University

Brief Summary:

Multiple sclerosis (MS) is a progressive neurological disease that affects over 2.5 million people worldwide. Up to 50% of persons with MS (PwMS) will experience some form of cognitive impairment as a result of the disease including disturbances in memory, attention, concentration, information processing, and executive functions such as problem solving, and self-monitoring. MS-related cognitive impairments negatively affect many aspects of functioning and independent participation in everyday life. Thus, PwMS who experience cognitive impairments face a wide array of recurring barriers that pose grave challenges to carrying out everyday activities while trying to maintain multiple life roles and as they age.

Management of cognitive symptoms can be addressed through rehabilitation which has the potential to reduce disability, prevent complications of the disease, and enhance participation, independence, and quality of life. Considering the high frequency of cognitive impairments in MS and their significant, complex impact on functioning and independence, it is critical that cognitive interventions be an essential component of MS rehabilitation.

The overarching goal of this study is to develop and test a self-management, group-based cognitive rehabilitation program designed specifically for PwMS.


Condition or disease Intervention/treatment
Multiple Sclerosis Cognitive Impairment Behavioral: Self-management cognitive rehabilitation group intervention Behavioral: Control intervention

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Development and Evaluation of a Cognitive Rehabilitation Program for Persons With Multiple Sclerosis
Study Start Date : February 2011
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cognitive intervention group
Cognitive rehabilitation program designed to be tested in this study
Behavioral: Self-management cognitive rehabilitation group intervention
8-week cognitive rehabilitation program facilitated by an occupational therapist. Program goals include increased knowledge of cognitive impairments in multiple sclerosis, increased self-efficacy to manage cognitive changes and increased use of cognitive compensatory strategies.
Active Comparator: Control group Behavioral: Control intervention
8-week group program that is not specifically directed to management of cognitive impairments.



Primary Outcome Measures :
  1. Cognitive strategy use [ Time Frame: pre intervention, post intervention, 3,6,12 month followup ]

Secondary Outcome Measures :
  1. Cognitive self-efficacy [ Time Frame: pre-intervention, post intervention, 3,6,12 month followup ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of MS
  • 18 years of age or older
  • Self-report of cognitive difficulties

Exclusion Criteria:

  • Exacerbation of symptoms in past 3 months
  • History of TBI, CVA, epilepsy, Psychiatric condition, drug/alcohol abuse

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): NCT01303770


Locations
Israel
Rabin Medical Center, Multiple Sclerosis Clinic
Petah Tikva, Israel, 49100
Sponsors and Collaborators
Tel Aviv University
Investigators
Principal Investigator: Eynat Shevil, PhD Tel Aviv University

Responsible Party: Eynat Shevil, Dr. Eynat Shevil, Tel Aviv University
ClinicalTrials.gov Identifier: NCT01303770     History of Changes
Other Study ID Numbers: MSCogRehab
PIRG03-GA-2008-230959 ( Other Grant/Funding Number: European Commission FP7 Marie Curie IRG )
First Posted: February 25, 2011    Key Record Dates
Last Update Posted: December 25, 2013
Last Verified: December 2013

Keywords provided by Eynat Shevil, Tel Aviv University:
Multiple Sclerosis
Cognitive impairment
Self-management programs
Occupational Therapy
Rehabilitation

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Cognitive Dysfunction
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders