The Effects of Attention Retraining in MS (MSattention)

March 8, 2013 updated by: Paivi Hamalainen, Finnish MS Society

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

97

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Masku, Finland, 212521
        • Masku Neurological Rehabilitation Centre
      • Seinäjoki, Finland, 60220
        • Seinajoki Central Hospital
      • Tampere, Finland
        • Tampere University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
control
control group: no intervention
neuropsychological rehabilitation
intervention group: neuropsychological rehabilitation (13 times 60 minutes, once per week, during 13 weeks) control group: no intervention
Behavioral: neuropsychological rehabilitation
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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: six months
The effects of rehabilitation on QoL: WHOQOL-Bref
six months
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
six months
Mood
Time Frame: six months
The effects of rehabilitation on mood: Beck Depression Inventory II (BDI II)
six months
Fatigue
Time Frame: six months
The effects of rehabilitation on self-perceived feeling of fatigue: Fatigue Scale for Motor and Cognitive Fatigue (FSMC)
six months
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)
six months
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)
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Finnish MS Society

Collaborators

Seinajoki Central Hospital
Social Insurance Institution, Finland
Tampere University Hospital

Investigators

  • Study Director: Päivi I Hämäläinen, adjunct prof, Finnish MS Society / Masku Neurological Rehabilitation Centre
  • Study Chair: Keijo Koivisto, Prof, Seinajoki Central Hospital
  • Principal Investigator: Eija M Rosti-Otajärvi, PhD, Tampere University Hospital
  • Principal Investigator: Anu Mäntynen, MA, Seinajoki Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

December 4, 2011

First Submitted That Met QC Criteria

December 12, 2011

First Posted (Estimate)

December 14, 2011

Study Record Updates

Last Update Posted (Estimate)

March 11, 2013

Last Update Submitted That Met QC Criteria

March 8, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS1209

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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