The Effects of Attention Retraining in MS (MSattention)
The Effects of Attention Retraining on Cognitive Performance, QoL and Perceived Cognitive Impairment in MS - a Single Blind, Randomized, Controlled Study
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Masku, Finland, 212521
- Masku Neurological Rehabilitation Centre
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Seinäjoki, Finland, 60220
- Seinäjoki Central Hospital
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Tampere, Finland
- Tampere University Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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control
control group: no intervention
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neuropsychological rehabilitation
intervention group: neuropsychological rehabilitation (13 times 60 minutes, once per week, during 13 weeks) control group: no intervention
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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)
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Objective cognitive performance
Tijdsspanne: six months
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effects of rehabilitation on objective cognitive performance: SDMT
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six months
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Subjective cognitive performance
Tijdsspanne: six months
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The effects of rehabilitation on subjective cognitive performance: perceived cognitive deficits (Perceived Deficits Questionnaire, PDQ)
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six months
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Goal achievement
Tijdsspanne: six months
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Goal achievement: Goal Attainment Scaling (GAS)
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six months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Quality of life
Tijdsspanne: six months
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The effects of rehabilitation on QoL: WHOQOL-Bref
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six months
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Objective cognitive performance
Tijdsspanne: six months
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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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six months
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Mood
Tijdsspanne: six months
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The effects of rehabilitation on mood: Beck Depression Inventory II (BDI II)
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six months
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Fatigue
Tijdsspanne: six months
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The effects of rehabilitation on self-perceived feeling of fatigue: Fatigue Scale for Motor and Cognitive Fatigue (FSMC)
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six months
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Subjective cognitive performance
Tijdsspanne: six months
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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)
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six months
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The impact of the disease
Tijdsspanne: six months
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The effects of rehabilitation on the impact of the disease: Multiple Sclerosis Impact Scale (MSIS-29)
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six months
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Studie directeur: Päivi I Hämäläinen, adjunct prof, Finnish MS Society / Masku Neurological Rehabilitation Centre
- Studie stoel: Keijo Koivisto, Prof, Seinäjoki Central Hospital
- Hoofdonderzoeker: Eija M Rosti-Otajärvi, PhD, Tampere University Hospital
- Hoofdonderzoeker: Anu Mäntynen, MA, Seinäjoki Central Hospital
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- MS1209
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