The Effects of Attention Retraining in MS

NCT ID: NCT01492023

Last Updated: 2013-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

97 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-05-31

Brief Summary

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The purpose of this study is to determine whether neuropsychological rehabilitation focused on attention retraining and teaching compensatory strategies has positive effects on cognitive performance, quality of life (QoL)and perceived cognitive deficits in patients with MS. The hypothesis is that the neuropsychological intervention shows positive effects on cognitive performance, QoL and perceived cognitive deficits.

Detailed Description

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Background: Cognitive impairments are a typical manifestation of multiple sclerosis (MS). According to previous studies, neuropsychological rehabilitation may improve cognitive performance in MS. However, the quality of previous studies is low and, accordingly, the evidence on the effects of neuropsychological rehabilitation is low to modest.

Objective: To study whether neuropsychological rehabilitation improves cognitive performance, QoL and perceived cognitive deficits in patients with MS.

Methods: Altogether 100 patients with MS are randomised either to intervention or to control group in three different study sites. All the study subjects are assessed with neuropsychological tests as well as self-rating questionnaires evaluating mood, QoL, cognitive deficits, fatigue and impact of the disease at baseline, after three months (immediately after intervention) and after six months. Patients in the intervention group are offered with neuropsychological rehabilitation conducted once a week during thirteen weeks. Patients in the control group do not receive any intervention.

Results: The effects of intervention on cognitive performance, QoL and perceived cognitive impairments are evaluated using appropriate statistical procedures and comparing the differences between the intervention and the control group.

The present status: The baseline assessments have been performed and the intervention will be conducted between September and December, 2011.

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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control

control group: no intervention

No interventions assigned to this group

neuropsychological rehabilitation

intervention group: neuropsychological rehabilitation (13 times 60 minutes, once per week, during 13 weeks) control group: no intervention

neuropsychological rehabilitation

Intervention Type BEHAVIORAL

attention retraining and teaching compensatory strategies as well as offering psychological support to better cope with cognitive impairments (13 times 60 minutes, once per week during 13 weeks)

Interventions

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neuropsychological rehabilitation

attention retraining and teaching compensatory strategies as well as offering psychological support to better cope with cognitive impairments (13 times 60 minutes, once per week during 13 weeks)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* clinically definite MS
* EDSS \< 6
* age 18-58 years
* subjective cognitive problems and objective decline in attention

Exclusion Criteria

* other neurological disease than MS
* psychiatric diagnosis
* severe depression
* secondary progressive or primary progressive course of MS
* EDSS\>=6
* alcohol or drug abuse
* relapse during the preceding month of study entry
* neuropsychological rehabilitation during the study
* no subjective cognitive cognitive problems and /or no decline in attention
* overall cognitive impairment (performance in all tests of BRBNT under -1.5 SD compared to norms of healthy controls)
Minimum Eligible Age

18 Years

Maximum Eligible Age

58 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Social Insurance Institution, Finland

OTHER

Sponsor Role collaborator

Tampere University Hospital

OTHER

Sponsor Role collaborator

Seinajoki Central Hospital

OTHER

Sponsor Role collaborator

Finnish MS Society

OTHER

Sponsor Role lead

Responsible Party

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Paivi Hamalainen

neuropsychologist, adjunct professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Päivi I Hämäläinen, adjunct prof

Role: STUDY_DIRECTOR

Finnish MS Society / Masku Neurological Rehabilitation Centre

Keijo Koivisto, Prof

Role: STUDY_CHAIR

Seinajoki Central Hospital

Eija M Rosti-Otajärvi, PhD

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Anu Mäntynen, MA

Role: PRINCIPAL_INVESTIGATOR

Seinajoki Central Hospital

Locations

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Masku Neurological Rehabilitation Centre

Masku, , Finland

Site Status

Seinajoki Central Hospital

Seinäjoki, , Finland

Site Status

Tampere University Hospital

Tampere, , Finland

Site Status

Countries

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Finland

Other Identifiers

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MS1209

Identifier Type: -

Identifier Source: org_study_id

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