NCT01303770

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 25, 2013

Status Verified

December 1, 2013

Enrollment Period

3.8 years

First QC Date

February 24, 2011

Last Update Submit

December 24, 2013

Conditions

Multiple SclerosisCognitive Impairment

Keywords

Multiple SclerosisCognitive impairmentSelf-management programsOccupational TherapyRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Cognitive strategy use

    pre intervention, post intervention, 3,6,12 month followup

Secondary Outcomes (1)

  • Cognitive self-efficacy

    pre-intervention, post intervention, 3,6,12 month followup

Study Arms (2)

Cognitive intervention group

EXPERIMENTAL

Cognitive rehabilitation program designed to be tested in this study

Behavioral: Self-management cognitive rehabilitation group intervention

Control group

ACTIVE COMPARATOR
Behavioral: Control intervention

Interventions

Self-management cognitive rehabilitation group interventionBEHAVIORAL

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.

Cognitive intervention group
Control interventionBEHAVIORAL

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

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center, Multiple Sclerosis Clinic

Petah Tikva, 49100, Israel

Location

MeSH Terms

Conditions

Multiple SclerosisCognitive Dysfunction

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Eynat Shevil, PhD

    Tel Aviv University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Eynat Shevil

Study Record Dates

First Submitted

February 24, 2011

First Posted

February 25, 2011

Study Start

February 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 25, 2013

Record last verified: 2013-12

Locations

IL(1)