Study Results
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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COMPLETED
97 participants
OBSERVATIONAL
2010-11-30
2012-05-31
Brief Summary
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Detailed Description
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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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Study Design
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CASE_CONTROL
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
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)
Eligibility Criteria
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Inclusion Criteria
* EDSS \< 6
* age 18-58 years
* subjective cognitive problems and objective decline in attention
Exclusion Criteria
* 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)
18 Years
58 Years
ALL
No
Sponsors
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Social Insurance Institution, Finland
OTHER
Tampere University Hospital
OTHER
Seinajoki Central Hospital
OTHER
Finnish MS Society
OTHER
Responsible Party
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Paivi Hamalainen
neuropsychologist, adjunct professor
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
Seinajoki Central Hospital
Seinäjoki, , Finland
Tampere University Hospital
Tampere, , Finland
Countries
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Other Identifiers
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MS1209
Identifier Type: -
Identifier Source: org_study_id
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