Clinical trial NCT01492023: The Effects of Attention Retraining in MS
Official title: The Effects of Attention Retraining on Cognitive Performance, QoL and Perceived Cognitive Impairment in MS - a Single Blind, Randomized, Controlled Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: neuropsychological
rehabilitation
multiple sclerosis
RCT study
Lead sponsor: Finnish MS Society
Sponsor class: OTHER
Collaborators: name: Social Insurance Institution, Finland
name: Tampere University Hospital
name: Seinajoki Central Hospital
First posted: 2011-12-14
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with MS are collected from community by informing about the study via information letters send to the members of local MS Associations

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Objective cognitive performance
timeFrame: six months
measure: Subjective cognitive performance
timeFrame: six months
measure: Goal achievement
timeFrame: six months
Secondary outcomes:
measure: Quality of life
timeFrame: six months
measure: Objective cognitive performance
timeFrame: six months
measure: Mood
timeFrame: six months
measure: Fatigue
timeFrame: six months
measure: Subjective cognitive performance
timeFrame: six months
measure: The impact of the disease
timeFrame: six months
Other outcomes:
Locations:
city: Masku
country: Finland
facility: Masku Neurological Rehabilitation Centre
city: Seinäjoki
country: Finland
facility: Seinajoki Central Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Finnish MS Society / Masku Neurological Rehabilitation Centre
name: Päivi I Hämäläinen, adjunct prof
role: STUDY_DIRECTOR
affiliation: Seinajoki Central Hospital
name: Keijo Koivisto, Prof
role: STUDY_CHAIR
affiliation: Tampere University Hospital
name: Eija M Rosti-Otajärvi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seinajoki Central Hospital
name: Anu Mäntynen, MA
role: PRINCIPAL_INVESTIGATOR
References: