The Effects of Attention Retraining in MS

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT01492023
• Lead Sponsor: Finnish MS Society

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-12-04
• Study First Submitted QC: 2011-12-12
• Study First Posted: 2011-12-14
• Primary Completion: 2012-04
• Study Completion: 2012-05
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-08
• Last Update Posted: 2013-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Subjective cognitive performance	six months	The effects of rehabilitation on subjective cognitive performance: perceived cognitive deficits (Perceived Deficits Questionnaire, PDQ)
Objective cognitive performance	six months	effects of rehabilitation on objective cognitive performance: SDMT
Goal achievement	six months	Goal achievement: Goal Attainment Scaling (GAS)

Secondary Outcome Measures

Name	Time	Method
Mood	six months	The effects of rehabilitation on mood: Beck Depression Inventory II (BDI II)
The impact of the disease	six months	The effects of rehabilitation on the impact of the disease: Multiple Sclerosis Impact Scale (MSIS-29)
Subjective cognitive performance	six months	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)
Quality of life	six months	The effects of rehabilitation on QoL: WHOQOL-Bref
Objective cognitive performance	six months	The effects of rehabilitation on cognitive performances: test of Brief Repeatable Battery of Neuropsychological Tests (BRBNT), Trail Making Test, Stroop test
Fatigue	six months	The effects of rehabilitation on self-perceived feeling of fatigue: Fatigue Scale for Motor and Cognitive Fatigue (FSMC)

Trial Locations

Locations (3)

Masku Neurological Rehabilitation Centre; 🇫🇮 Masku, Finland

Seinajoki Central Hospital; 🇫🇮 Seinäjoki, Finland

Tampere University Hospital; 🇫🇮 Tampere, Finland