The Effects of Attention Retraining in MS

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effects of Attention Retraining on Cognitive Performance, QoL and Perceived Cognitive Impairment in MS - a Single Blind, Randomized, Controlled Study

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: neuropsychological rehabilitation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 58 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| control<br>control group: no intervention | |
| neuropsychological rehabilitation<br>intervention group: neuropsychological rehabilitation (13 times 60 minutes, once per week, during 13 weeks) control group: no intervention | Behavioral: neuropsychological rehabilitation<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuropsychological, rehabilitation, multiple sclerosis, RCT study