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

• Sponsor: Tel Aviv University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01303770
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 46
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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	Phase
Multiple Sclerosis; Cognitive Impairment	Behavioral: Self-management cognitive rehabilitation group intervention; Behavioral: Control intervention	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Feb 1, 2011
• Anticipated Primary Completion Date: Dec 1, 2014
• Anticipated Study Completion Date: Dec 1, 2014

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Cognitive strategy use [pre intervention, post intervention, 3,6,12 month followup]

Secondary Outcome Measures

1. Cognitive self-efficacy [pre-intervention, post intervention, 3,6,12 month followup]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eynat Shevil, Dr. Eynat Shevil, Tel Aviv University
• ClinicalTrials.gov Identifier: NCT01303770
• Other Study ID Numbers: MSCogRehab; PIRG03-GA-2008-230959
• First Posted: Feb 25, 2011
• Last Update Posted: Dec 25, 2013
• Last Verified: Dec 1, 2013

• Keywords provided by Eynat Shevil, Dr. Eynat Shevil, Tel Aviv University: Multiple Sclerosis; Cognitive impairment; Self-management programs; Occupational Therapy; Rehabilitation
• Additional relevant MeSH terms: Multiple Sclerosis; Sclerosis; Cognitive Dysfunction

Study Results

No Results Posted as of Dec 25, 2013