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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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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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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Objective cognitive performance
Tidsramme: six months
|
effects of rehabilitation on objective cognitive performance: SDMT
|
six months
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Subjective cognitive performance
Tidsramme: 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
|
|
Goal achievement
Tidsramme: six months
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Goal achievement: Goal Attainment Scaling (GAS)
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six months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Quality of life
Tidsramme: six months
|
The effects of rehabilitation on QoL: WHOQOL-Bref
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six months
|
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Objective cognitive performance
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Päivi I Hämäläinen, adjunct prof, Finnish MS Society / Masku Neurological Rehabilitation Centre
- Studiestol: Keijo Koivisto, Prof, Seinäjoki Central Hospital
- Hovedetterforsker: Eija M Rosti-Otajärvi, PhD, Tampere University Hospital
- Hovedetterforsker: Anu Mäntynen, MA, Seinäjoki Central Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MS1209
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