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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Masku, Finlandia, 212521
- Masku Neurological Rehabilitation Centre
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Seinäjoki, Finlandia, 60220
- Seinajoki Central Hospital
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Tampere, Finlandia
- Tampere university Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Objective cognitive performance
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: six months
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Goal achievement: Goal Attainment Scaling (GAS)
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six months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Quality of life
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Päivi I Hämäläinen, adjunct prof, Finnish MS Society / Masku Neurological Rehabilitation Centre
- Silla de estudio: Keijo Koivisto, Prof, Seinajoki Central Hospital
- Investigador principal: Eija M Rosti-Otajärvi, PhD, Tampere university Hospital
- Investigador principal: Anu Mäntynen, MA, Seinajoki Central Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MS1209
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