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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eynat Shevil, Tel Aviv University
ClinicalTrials.gov Identifier:
NCT01303770
First received: February 24, 2011
Last updated: December 24, 2013
Last verified: December 2013

February 24, 2011
December 24, 2013
February 2011
December 2014   (final data collection date for primary outcome measure)
Cognitive strategy use [ Time Frame: pre intervention, post intervention, 3,6,12 month followup ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01303770 on ClinicalTrials.gov Archive Site
Cognitive self-efficacy [ Time Frame: pre-intervention, post intervention, 3,6,12 month followup ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Development and Evaluation of a Cognitive Rehabilitation Program for Persons With Multiple Sclerosis
Development and Evaluation of a Cognitive Rehabilitation Program for Persons With Multiple Sclerosis

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
  • Multiple Sclerosis
  • Cognitive Impairment
  • 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.
  • Behavioral: Control intervention
    8-week group program that is not specifically directed to management of cognitive impairments.
  • Experimental: Cognitive intervention group
    Cognitive rehabilitation program designed to be tested in this study
    Intervention: Behavioral: Self-management cognitive rehabilitation group intervention
  • Active Comparator: Control group
    Intervention: Behavioral: Control intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01303770
MSCogRehab, PIRG03-GA-2008-230959
Not Provided
Eynat Shevil, Tel Aviv University
Tel Aviv University
Not Provided
Principal Investigator: Eynat Shevil, PhD Tel Aviv University
Tel Aviv University
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP