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

Not Applicable

• Conditions: Multiple Sclerosis; Cognitive Impairment

• Registration Number: NCT01303770
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-24
• Study First Submitted QC: 2011-02-24
• Study First Posted: 2011-02-25
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-24
• Last Update Posted: 2013-12-25
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cognitive strategy use	pre intervention, post intervention, 3,6,12 month followup

Secondary Outcome Measures

Name	Time	Method
Cognitive self-efficacy	pre-intervention, post intervention, 3,6,12 month followup

Trial Locations

Locations (1)

Rabin Medical Center, Multiple Sclerosis Clinic; 🇮🇱 Petah Tikva, Israel