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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01303770
• Other study ID #: MSCogRehab
• Secondary ID: PIRG03-GA-2008-2
• Status: Active, not recruiting
• Phase: N/A
• First received: February 24, 2011
• Last updated: December 24, 2013
• Start date: February 2011
• Est. completion date: December 2014

Study information

• Verified date: December 2013
• Source: Tel Aviv University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Impairment
• Multiple Sclerosis
• Sclerosis

Intervention

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.
• Control intervention
8-week group program that is not specifically directed to management of cognitive impairments.

Locations

Country	Name	City	State
Israel	Rabin Medical Center, Multiple Sclerosis Clinic	Petah Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Tel Aviv University

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive strategy use		pre intervention, post intervention, 3,6,12 month followup	No
Secondary	Cognitive self-efficacy		pre-intervention, post intervention, 3,6,12 month followup	No