Skip to main content
OpenTrials
Completed

NCT Number: NCT01492023

The Effects of Attention Retraining in MS

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–58 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Masku Neurological Rehabilitation Centre, Masku, Finland

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Neuropsychological rehabilitation

Behavioral

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)

Primary outcomes

  1. Objective cognitive performance

    Time frame: six months

    effects of rehabilitation on objective cognitive performance: SDMT

  2. Subjective cognitive performance

    Time frame: six months

    The effects of rehabilitation on subjective cognitive performance: perceived cognitive deficits (Perceived Deficits Questionnaire, PDQ)

  3. Goal achievement

    Time frame: six months

    Goal achievement: Goal Attainment Scaling (GAS)

Secondary outcomes

  1. Quality of life

    Time frame: six months

    The effects of rehabilitation on QoL: WHOQOL-Bref

  2. Objective cognitive performance

    Time frame: six months

    The effects of rehabilitation on cognitive performances: test of Brief Repeatable Battery of Neuropsychological Tests (BRBNT), Trail Making Test, Stroop test

  3. Mood

    Time frame: six months

    The effects of rehabilitation on mood: Beck Depression Inventory II (BDI II)

  4. Fatigue

    Time frame: six months

    The effects of rehabilitation on self-perceived feeling of fatigue: Fatigue Scale for Motor and Cognitive Fatigue (FSMC)

  5. Subjective cognitive performance

    Time frame: 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)

  6. The impact of the disease

    Time frame: six months

    The effects of rehabilitation on the impact of the disease: Multiple Sclerosis Impact Scale (MSIS-29)

Sponsors and collaborators

Lead sponsor

Finnish MS Society

Other

Collaborators

  • Seinajoki Central Hospital
  • Social Insurance Institution, Finland
  • Tampere University Hospital

Registry information

Official study title

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

Acronym: MSattention

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 14, 2011
Registry last updated
Mar 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.