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| Name | Class |
|---|---|
| Social Insurance Institution, Finland | OTHER |
| Tampere University Hospital | OTHER |
| Seinajoki Central Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | control group: no intervention | ||
| neuropsychological rehabilitation | intervention group: neuropsychological rehabilitation (13 times 60 minutes, once per week, during 13 weeks) control group: no intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neuropsychological rehabilitation | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective cognitive performance | effects of rehabilitation on objective cognitive performance: SDMT | six months |
| Subjective cognitive performance | The effects of rehabilitation on subjective cognitive performance: perceived cognitive deficits (Perceived Deficits Questionnaire, PDQ) | six months |
| Goal achievement | Goal achievement: Goal Attainment Scaling (GAS) | six months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | The effects of rehabilitation on QoL: WHOQOL-Bref | six months |
| Objective cognitive performance | The effects of rehabilitation on cognitive performances: test of Brief Repeatable Battery of Neuropsychological Tests (BRBNT), Trail Making Test, Stroop test |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with MS are collected from community by informing about the study via information letters send to the members of local MS Associations
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| Name | Affiliation | Role |
|---|---|---|
| Päivi I Hämäläinen, adjunct prof | Finnish MS Society / Masku Neurological Rehabilitation Centre | Study Director |
| Keijo Koivisto, Prof | Seinajoki Central Hospital | Study Chair |
| Eija M Rosti-Otajärvi, PhD | Tampere University Hospital | Principal Investigator |
| Anu Mäntynen, MA | Seinajoki Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masku Neurological Rehabilitation Centre | Masku | 212521 | Finland | |||
| Seinajoki Central Hospital |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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A randomised, controlled, single-blind study
| six months |
| Mood | The effects of rehabilitation on mood: Beck Depression Inventory II (BDI II) | six months |
| Fatigue | The effects of rehabilitation on self-perceived feeling of fatigue: Fatigue Scale for Motor and Cognitive Fatigue (FSMC) | six months |
| Subjective cognitive performance | The effects of rehabilitation on subjective cognitive performance evaluated by the patient him/herself or the significant other: Multiple Sclerosis Neuropsychological Questionnaire (MSNQ-P, MSNQ-I) | six months |
| The impact of the disease | The effects of rehabilitation on the impact of the disease: Multiple Sclerosis Impact Scale (MSIS-29) | six months |
| Seinäjoki |
| 60220 |
| Finland |
| Tampere University Hospital | Tampere | Finland |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |